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Cognitive behavioural therapy (CBT) with and without exercise

to reduce fear of falling in older people living in the community
(Review)
Lenouvel E, Ullrich P, Siemens W, Dallmeier D, Denkinger M, Kienle G, Zijlstra GAR, Hauer K,

Klöppel S
Lenouvel E, Ullrich P, Siemens W, Dallmeier D, Denkinger M, Kienle G, Zijlstra GA, Hauer K, Klöppel S.
Cognitive behavioural therapy (CBT) with and without exercise to reduce fear of falling in older people living in the community.
Cochrane Database of Systematic Reviews 2023, Issue 11. Art. No.: CD014666.
DOI: 10.1002/14651858.CD014666.pub2.
www.cochranelibrary.com
Cognitive behavioural therapy (CBT) with and without exercise to reduce fear of falling in older people living in
the community (Review)
Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
TABLE OF CONTENTS
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
SUMMARY OF FINDINGS.............................................................................................................................................................................. 4
BACKGROUND.............................................................................................................................................................................................. 7
OBJECTIVES.................................................................................................................................................................................................. 9
METHODS..................................................................................................................................................................................................... 9
RESULTS........................................................................................................................................................................................................ 13
Figure 1.................................................................................................................................................................................................. 14
Figure 2.................................................................................................................................................................................................. 18
Figure 3.................................................................................................................................................................................................. 19
DISCUSSION.................................................................................................................................................................................................. 22
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 25
ACKNOWLEDGEMENTS................................................................................................................................................................................ 26
REFERENCES................................................................................................................................................................................................ 27
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 35
DATA AND ANALYSES.................................................................................................................................................................................... 56
Analysis 1.1. Comparison 1: Fear of falling: immediate postintervention, Outcome 1: Fear of falling: subgrouped according to 58
intervention approach..........................................................................................................................................................................
mean age...............................................................................................................................................................................................
control....................................................................................................................................................................................................
"A Matter of Balance" (AMB) versus non-AMB based interventions..................................................................................................
group versus individual interventions.................................................................................................................................................
Analysis 2.1. Comparison 2: Fear of falling: sustainability of effects, up to 6 months' postintervention, Outcome 1: Fear of falling: 63
subgrouped according to intervention approach...............................................................................................................................
subgrouped according to control........................................................................................................................................................
subgrouped according to AMB versus non-AMB based interventions...............................................................................................
subgrouped according to group versus individual interventions......................................................................................................
Analysis 3.1. Comparison 3: Fear of falling: sustainability of effects, more than 6 months' postintervention, Outcome 1: Fear of 67
falling: subgrouped according to intervention approach..................................................................................................................
falling: subgrouped according to "A Matter of Balance" (AMB) versus non-AMB based interventions............................................
falling: subgrouped according to group versus individual interventions..........................................................................................
Analysis 4.1. Comparison 4: Secondary outcomes, Outcome 1: Activity avoidance: immediate postintervention......................... 69
Analysis 4.2. Comparison 4: Secondary outcomes, Outcome 2: Occurrence of falls: immediate postintervention........................ 70
Analysis 4.3. Comparison 4: Secondary outcomes, Outcome 3: Depression: immediate postintervention.................................... 70
Analysis 4.4. Comparison 4: Secondary outcomes, Outcome 4: Anxiety: immediate postintervention........................................... 71
Analysis 4.5. Comparison 4: Secondary outcomes, Outcome 5: Quality of life: immediate postintervention................................. 71
ADDITIONAL TABLES.................................................................................................................................................................................... 72
APPENDICES................................................................................................................................................................................................. 78
HISTORY........................................................................................................................................................................................................ 89
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 89
DECLARATIONS OF INTEREST..................................................................................................................................................................... 89
SOURCES OF SUPPORT............................................................................................................................................................................... 89
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 90
INDEX TERMS............................................................................................................................................................................................... 91
Cognitive behavioural therapy (CBT) with and without exercise to reduce fear of falling in older people living in the community (Review) i
Informed decisions.
[Intervention Review]
Cognitive behavioural therapy (CBT) with and without exercise to reduce

fear of falling in older people living in the community
Eric Lenouvel1,2, Phoebe Ullrich3,4, Waldemar Siemens5,6, Dhayana Dallmeier7,8, Michael Denkinger9,10, Gunver Kienle11, G A Rixt
Zijlstra12,13,14, Klaus Hauer3,15, Stefan Klöppel1
1University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern (UPD), Bern, Switzerland. 2Graduate School for
Health Science, University of Bern, Bern, Switzerland. 3Geriatrisches Zentrum am Universitätsklinikum Heidelberg, AGAPLESION
Bethanien Krankenhaus, Heidelberg, Germany. 4Department of Thoracic Oncology, Thoraxklinik Heidelberg, Heidelberg University
Hospital, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL), Röntgenstraße 1, D-69126,
Heidelberg, Germany. 5Institute for Evidence in Medicine, Medical Center – University of Freiburg, Faculty of Medicine, University of
Freiburg, Freiburg, Germany. 6Cochrane Germany, Cochrane Germany Foundation, Freiburg, Germany. 7AGAPLESION Bethesda Clinic
Ulm, Research Unit on Ageing, Ulm, Germany. 8Department of Epidemiology, Boston University School of Public Health, Boston, USA.
9Institute for Geriatric Research, University of Ulm Medical Center, Ulm, Germany. 10AGAPLESION Bethesda Clinic Ulm, Geriatric Centre
Ulm/Alb-Donau, Ulm, Germany. 11Department of Medicine II, Medical Center, University of Freiburg, Freiburg, Germany, Freiburg,
Germany. 12Care and Public Health Research Institute, Department of Health Services Research, Maastricht University, Maastricht,
Netherlands. 13Public Health Service Flevoland (GGD Flevoland), Department of Health Policy & Research, Lelystad, Netherlands,
Netherlands. 14Health Care and Social Work Division, Windesheim University of Applied Sciences, Almere The Netherlands, Netherlands.
15Robert Bosch Gesellschaft für Medizinische Forschung mbH, Stuttgart, Germany
Contact: Eric Lenouvel, eric.lenouvel@upd.unibe.ch.
Editorial group: Cochrane Bone, Joint and Muscle Trauma Group.

Publication status and date: New, published in Issue 11, 2023.
Citation: Lenouvel E, Ullrich P, Siemens W, Dallmeier D, Denkinger M, Kienle G, Zijlstra GA, Hauer K, Klöppel S. Cognitive behavioural
therapy (CBT) with and without exercise to reduce fear of falling in older people living in the community. Cochrane Database of
Systematic Reviews 2023, Issue 11. Art. No.: CD014666. DOI: 10.1002/14651858.CD014666.pub2.
ABSTRACT
Background
Fear of falling (FoF) is a lasting concern about falling that leads to an individual avoiding activities that he/she remains capable of
performing. It is a common condition amongst older adults and may occur independently of previous falls. Cognitive behavioural therapy
(CBT), a talking therapy that helps change dysfunctional thoughts and behaviour, with and without exercise, may reduce FoF, for example,
by reducing catastrophic thoughts related to falls, and modifying dysfunctional behaviour.
Objectives
To assess the benefits and harms of CBT for reducing FoF in older people living in the community, and to assess the effects of interventions
where CBT is used in combination with exercise.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 1, 2023), MEDLINE Ovid (from 1946 to 11 January 2023),
Embase Ovid (from 1980 to 11 January 2023), CINAHL Plus (Cumulative Index to Nursing and Allied Health Literature) (from 1982 to 11
January 2023), PsycINFO (from 1967 to 11 January 2023), and AMED (Allied and Complementary Medicine from 1985 to 11 January 2023).
We handsearched reference lists and consulted experts for identifying additional studies.
Cognitive behavioural therapy (CBT) with and without exercise to reduce fear of falling in older people living in the community (Review) 1
Informed decisions.
Selection criteria
This review included randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs assessing CBT with and without exercise
interventions compared to control groups with sham-treatment, or treatment as usual. We defined CBT as a collaborative, time-limited,
goal-oriented, and structured form of speaking therapy. Included studies recruited community-dwelling older adults, with a mean
population age of at least 60 years minus one standard deviation, and not defined by a specific medical condition.
Data collection and analysis

Two review authors used standard methodological procedures expected by Cochrane. For continuous data, as assessed by single- or
multiple-item questionnaires, we report the mean difference (MD) with 95% confidence interval (CI) when studies used the same outcome
measures, and standardised mean difference (SMD) when studies used different measures for the same clinical outcome. For dichotomous
outcomes, we reported the treatment effects as risk ratios (RR) with 95% CIs. We measured the primary outcome, FoF, immediately, up to,
and more than six months after the intervention. We analysed secondary outcomes of activity avoidance, occurrence of falls, depression,
and quality of life when measured immediately after the intervention. We assessed risk of bias for each included study, using the GRADE
approach to assess the certainty of evidence.
Main results
We selected 12 studies for this review, with 11 studies included for quantitative synthesis. One study could not be included due to missing
information. Of the 11 individual studies, two studies provided two comparisons, which resulted in 13 comparisons. Eight studies were
RCTs, and four studies were cluster-RCTs. Two studies had multiple arms (CBT only and CBT with exercise) that fulfilled the inclusion criteria.
The primary aim of 10 studies was to reduce FoF. The 11 included studies for quantitative synthesis involved 2357 participants, with mean
ages between 73 and 83 years. Study total sample sizes varied from 42 to 540 participants. Of the 13 comparisons, three investigated CBT-
only interventions while 10 investigated CBT with exercise. Intervention duration varied between six and 156 hours, at a frequency between
three times a week and monthly over an eight- to 48-week period. Most interventions were delivered in groups of between five and 10
participants, and, in one study, up to 25 participants. Included studies had considerable heterogeneity, used different questionnaires, and
had high risks of bias.
CBT interventions with and without exercise probably improve FoF immediately after the intervention (SMD −0.23, 95% CI −0.36 to −0.11;
11 studies, 2357 participants; moderate-certainty evidence). The sensitivity analyses did not change the intervention effect significantly.
Effects of CBT with or without exercise on FoF may be sustained up to six months after the intervention (SMD −0.24, 95% CI −0.41 to
−0.07; 8 studies, 1784 participants; very low-certainty evidence). CBT with or without exercise interventions for FoF probably sustains
improvements beyond six months (SMD −0.28, 95% CI −0.40 to −0.15; 5 studies, 1185 participants; moderate-certainty of evidence).
CBT interventions for reducing FoF may reduce activity avoidance (MD −2.57, 95% CI −4.67 to −0.47; 1 study, 312 participants; low-certainty
evidence), and level of depression (SMD −0.41, 95% CI −0.60 to −0.21; 2 studies, 404 participants; low-certainty evidence). We are uncertain
whether CBT interventions reduce the occurrence of falls (RR 0.96, 95% CI 0.66 to 1.39; 5 studies, 1119 participants; very low-certainty
evidence).
All studies had a serious risk of bias, due to performance bias, and at least an unclear risk of detection bias, as participants and assessors
could not be blinded due to the nature of the intervention. Downgrading of certainty of evidence also occurred due to heterogeneity
between studies, and imprecision, owing to limited sample size of some studies. There was no reporting bias suspected for any article.
No studies reported adverse effects due to their interventions.
Authors' conclusions
CBT with and without exercise interventions probably reduces FoF in older people living in the community immediately after the
intervention (moderate-certainty evidence). The improvements may be sustained during the period up to six months after intervention
(low-certainty evidence), and probably are sustained beyond six months (moderate-certainty evidence). Further studies are needed to
improve the certainty of evidence for sustainability of FoF effects up to six months.
Of the secondary outcomes, we are uncertain whether CBT interventions for FoF reduce the occurrence of falls (very low-certainty
evidence). However, CBT interventions for reducing FoF may reduce the level of activity avoidance, and may reduce depression (low-
certainty evidence). No studies reported adverse effects.
Future studies could investigate different populations (e.g. nursing home residents or people with comorbidities), intervention
characteristics (e.g. duration), or comparisons (e.g. CBT versus exercise), investigate adverse effects of the interventions, and add outcomes
(e.g. gait analysis). Future systematic reviews could search specifically for secondary outcomes.
PLAIN LANGUAGE SUMMARY
Cognitive behavioural interventions for reducing fear of falling in older people living in the community
Key messages
Informed decisions.
– Cognitive behavioural therapy (CBT) with and without exercise probably reduces fear of falling in older people living in the community,
when measured once treatment has ended. Improvements may be sustained during the first six months after treatment finished, and
probably last beyond six months.
– As a consequence of these interventions, people may be less likely to avoid activities after treatment and their level of depression may
be reduced.
– It is unclear if the frequency of falls is reduced following treatment.
– We do not know if there are any adverse effects (harms) caused by CBT with and without exercise for reducing fear of falling, as none of
the studies measured this as one of their outcomes. We need more studies looking at adverse effects.
What is fear of falling?
Fear of falling is a lasting concern about falling that leads to a person avoiding activities that he/she remains capable of performing. Fear
of falling is common among older adults. They may be warned by healthcare professionals, family, and friends of the dangers of falls, as
well have witnessed directly or indirectly the consequences of a fall. This is significant as up to 34% of older adults fall each year, with 5%
experiencing bone fractures. Furthermore, they may recognise that their body is not as strong as it was when they were younger, adding
to concern that they may not be able to protect themselves from a fall, and must, therefore, take preventive measures to avoid falling.
People with fear of falling can experience physical, psychological, and social consequences. Treating fear of falling is therefore important
to reduce dysfunctional cognitions and behaviours leading to these consequences.
How is the condition treated?
There are several treatment approaches: cognitive behavioural therapy (CBT) (a talking therapy that helps change thoughts and
behaviour), exercise (a planned, structured, and repetitive physical activity to help keep the body healthy), or a combination of both. These
treatments are usually given in group settings by trained therapists.
What did we want to find out?
We wanted to find out if CBT with and without exercise in older adults living in the community (who live in places without additional
support, such as assisted living centres) were better than usual care or dummy treatments in reducing fear of falling. We also wanted to
see how CBT with and without exercise affected activity avoidance, falls, and depression, or if it caused any harm.
What did we do?

We searched several electronic databases and consulted experts for studies that compared interventions to reduce fear of falling using
CBT alone and CBT with exercise.
We combined and summarised the results across the studies. We rated our confidence in the evidence based on factors such as study
design, methods, and numbers of participants.
What did we find?
We found 12 relevant studies, of which 11 studies were included for statistical analyses with a total of 2383 people, with a mean age varying
from 73 to 83 years. The therapy (CBT or dummy treatment) was given at a frequency from three times per week to once per month, for
eight to 48 weeks. Added up, the treatments lasted between six and 156 hours. Most interventions were given in groups of between five
and 10 participants, and in one study up to 25. The primary aim of 10 studies was to reduce fear of falling.
Main results
We found that CBT with and without exercise interventions probably reduces fear of falling in older people living in the community once
treatment has ended. Improvements may be sustained during the first six months after treatment finished, and probably last beyond six
months. Additionally, we found that people may be less likely to avoid activities, and may reduce their level of depression. It remains
unclear if the frequency of falls improves after treatment.
What are the limitations of the evidence?
Our confidence in the evidence was limited because the results may have been influenced by the participants in the studies knowing which
treatment they received and the studies used different ways of delivering the interventions.
To improve our certainty of the evidence, we would need more studies, with more similarity in how they treated and measured fear of
falling.
How up to date is this evidence?
This evidence is up to date to 11 January 2023.
Cognitive behavioural therapy (CBT) with and without exercise to reduce fear of falling in older people living in the community (Review)
SUMMARY OF FINDINGS
Summary of findings 1. CBT interventions (CBT with and without exercise) compared to control (standard care or sham treatments) for reducing fear
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of falling (FoF) in older people living in the community
CBT interventions (with and without exercise) compared to control (standard care or sham treatments) for reducing fear of falling (FoF) in older people living in
the community
Patient or population: older adults (mean age minus 1 standard deviation is more than 60 years)
Better health.
Informed decisions.
Trusted evidence.
Setting: community living
Intervention: CBT interventions (with and without exercise)
Comparison: control (standard care or sham treatments) for FoF
Outcomes Anticipated absolute effects* (95% Relative effect № of partici- Certainty of Comments
CI) (95% CI) pants the evidence
(studies) (GRADE)
Risk with con- Risk with CBT in-
trol (standard terventions (CBT
care or sham with and without
treatments) exercise)
Licensed to CECÍLIA RODRIGUES ROSA - ceciliagyn@hotmail.com

for FoF
FoF (immediate postinter- — SMD 0.23 lower — 2357 ⊕⊕⊕⊝ This SMD indicated a small effect.b
vention)a (0.36 lower to 0.11 (11 RCTs)c Moderated
lower)b This corresponds to a reduction on the
Assessed with: FES-S, mFES, FES-I scale of 2.2 (95% CI −3.4 to −1.0).
FES-I, FES, ABC, and sin-
gle-item instruments In the control group, mean FES-S score
was 106.2, mFES ranged from 28.2 to
Follow-up: immediately after 35.3, mean FES-I from 27.15 to 39.53,
intervention mean FES was 88.69, ABC was 150.3,
mean single-item instruments from 1.7
to 1.8.

FoF (sustainability of ef- — SMD 0.24 lower — 1784 ⊕⊕⊝⊝ This SMD indicated a small effect.b
fects, up to 6 months' (0.41 lower to 0.07 (8 RCTs)e Lowd,f
postintervention) lower)b This corresponds to a reduction on
the FES-I scale of 2.3 (95% CI −4.3 to
Assessed with: −0.19).
FES-S, mFES, FES-I, FES, and In the control group, mean FES-S score
ABC was 99.0, mFES ranged from 29.4 to
35.86, mean FES-I from 34.1 to 38.07,
Follow-up: 1–6 months after mean FES was 88.4, ABC was 146.9.
the intervention
4
FoF (sustainability of ef- — SMD 0.28 lower — 1185 ⊕⊕⊕⊝ This SMD indicated a small effect.b
fects, > 6 months' postinter- (0.40 lower to 0.15 (5 RCTs) Moderate d
vention) lower) b This corresponds to a reduction on the
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FES-I scale of 2.6 (95% CI −3.8 to −1.8).
Assessed with:
In the control group, mean FES-S score
FES-S, mFES, and FES-I was 99.0, mFES ranged from 28.9 to
35.86, mean FES-I mean was 38.68.
Follow-up: 12–24 months'
postintervention
Better health.
Informed decisions.
Trusted evidence.
Activity avoidance In the control MD 2.57 lower — 312 ⊕⊕⊝⊝ —
Assessed with: FES-IAB group, mean (4.67 lower to 0.47 (1 RCT) Lowd,g
FES-IAB score lower)
Follow-up: immediately after was 28.74
intervention
Occurrence of falls 482 per 1000h 462 per 1000 RR 0.96 1119 ⊕⊝⊝⊝ An RR < 1 favours intervention group.
(318 to 669) (0.66 to 1.39) (5 RCTs) Very lowd,f,g
Follow-up: immediately after
intervention

Depression For CBT only For CBT only inter- — For CBT only in- ⊕⊕⊝⊝ SMD −0.41, 95% CI −0.60 to −0.21b
interventions ventions, MD 1.26 terventions, 314 Lowd,g
Assessed with: control group, lower (1.96 lower (1 RCT)
mean HADS-D to 0.56 lower)
HADS-D and GDS
score was 0.1
Follow-up: immediately after
intervention For CBT with ex- For CBT with ex- For CBT with ex-
ercise interven- ercise interven- ercise interven-
tions control tions, MD 0.38 low- tions, 90 (1 RCT)
group, mean er (0.80 lower to
GDS score was 0.04 higher)
0.79

Adverse effects — — — — — No studies reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and
its 95% CI).
ABC: Activities-Specific Balance Confidence Scale, range 0 to 100, a high score represents a high level of physical functioning; CBT: cognitive behavioural therapy; CI: con-
fidence Interval; FES: Falls Efficacy Scale, range 10 to 100, lower scores represent lower concerns about falling; FES-I: FES-International, range 16 to 64, lower scores repre-
sent lower concerns about falling; FES-IAB: FES International Avoidance Behaviour, range 16 to 64, a low score represents low activity avoidance; FES-S: Falls Efficacy Scale
Swedish variant, range 0 to 130, lower scores represent lower concerns about falling; FoF: fear of falling; GDS: Geriatric Depression Scale, range 0 to 15, a low score repre-
sents low level of depression; HADS-D: Hospital Anxiety and Depression Scale - Depression subscale, range 0 to 21, a low score represents low level of depression; MD: mean
5
difference; mFES: Modified FES, range 16 to 64, lower scores represent lower concerns about falling; RCT: randomised controlled trial; RR: risk ratio; Single-Item Instru-
ments: two instruments, ranging 1 to 4 and 1 to 5, a high score represents high FoF; SMD: standardised mean difference.
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GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is
substantially different.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
Better health.
Informed decisions.
Trusted evidence.
a The interventions fell into two categories: cognitive behavioural therapy (CBT) only interventions and multicomponent interventions, combining CBT and exercise interventions.
Two studies were multiple arm studies, having both a CBT only arm and a CBT with exercise arm.
b The rating of effect was based on a rule of thumb interpretation in which an SMD of 0.2 to 0.5 indicates a small effect, 0.5 to 0.8 a moderate effect, and over 0.8 a large effect.
c There were 11 studies included for quantitative synthesis, of which two had two arms (CBT only and CBT with exercise) (Huang 2011; Reinsch 1992).
d Downgraded one level due to serious risk of bias; blinding of participants and assessors not possible due to nature of the intervention.
e There were eight studies included for quantitative synthesis, of which one had two arms (CBT only and CBT with exercise) (Huang 2011).
f Downgraded one level due to serious inconsistency; heterogeneity existed between studies in CBT with exercise group; or heterogeneity existed between pooled studies.
g Downgraded one level due to serious imprecision; CIs indicated both benefit and harm; or insufficient number of participants (fewer than 200).
h Derived from the pooled estimate of the control group.

6
Informed decisions.
BACKGROUND functional impairments, the use of a walking aid, a history of falls,

and depression (Asai 2022; Denkinger 2015; Park 2017). Anxiety
Description of the condition was found to be an indirect predisposing factor for FoF, affecting
self-confidence at avoiding falls and restricting activity, which then
First introduced as a concept in 1982 by Murphy and Isaac, fear of
predisposes to FoF (Denkinger 2015).
falling (FoF) was defined in 1993 by Tinetti and colleagues as "a
lasting concern about falling that leads to an individual avoiding Protective factors against FoF have been found to be social support,
activities that he/she remains capable of performing" (Murphy participating in frequent social activities, increased opportunities
1982; Tinetti 1993). FoF is an umbrella term relating to different for physical activities (Howland 1998; Lee 2018). Howland 1998 also
concepts, assessment, and emerging intervention strategies. FoF, reported that "those who could rely on others or talk with friends
concern about falling, falls-efficacy, fall-related psychological about falling were least likely to report activity curtailment".
concerns (FRCPs), ptophobia, fall-related anxiety, and fear-related
activity avoidance are often used interchangeably; however, they FoF has serious adverse health outcomes. FoF is associated with
represent different psychological constructs (Ellmers 2023; Jørstad avoidance of activity (Zijlstra 2007), decreased social participation
2005). The fear in FoF describes a state of apprehension towards (Pin 2016), lower self-efficacy (Cumming 2000; Denkinger 2010),
a danger, the fall; "falls-efficacy" describes the level of confidence decreased ability to perform activities of daily living (ADLs)
towards the ability to mitigate the threat, that of falls, and as (Cumming 2000), a decreased quality of life (Schoene 2019),
such is considered a resiliency factor influencing the level of fear and anxiety (Painter 2012), and loss of balance confidence
FoF (Payette 2016); "Concern about falling," is a term that is (Hadjistavropoulos 2012). Altered gait parameters have been
closely related to fear, but is less intense and emotional (and associated with FoF, with a slowed gait, shorter stride length,
therefore may be more socially acceptable for older people to slower step rate, longer double support time (time when both feet
disclose) (Jørstad 2005; Yardley 2005). However, concern describes are on the ground), and greater variability in stride length (Makino
a solution-orientated cognitive response whereas fear is an innate 2017).
response (Levy 1985). Anxiety, often used to describe FoF, describes
a state of apprehension towards a future, imagined danger. Secondary diagnoses, such as depression can also develop
(Denkinger 2015). Consequently, the resultant health costs are
The behavioural reactions seen in those with FoF may be significant (Heinrich 2010). Van Haastegt and colleagues found that
maladaptive or adaptive (Ellmers 2022). Maladaptive behaviours FoF interventions could be more cost-effective than treating the
seen in FoF reflects a mismatch between physiological fall risk and associated symptoms that may develop from FoF (van Haastregt
one's perceived risk of falling. Adamczewska 2018 proposes that 2013).
FoF may have a protective element against falls, when there is
a focus on the immediate threat, as felt by fear, rather than the Measuring FoF has been achieved through different approaches
future threat, as felt by anxiety, which would predispose to a vicious (Greenberg 2012; McGarrigle 2023; Moore 2008; Soh 2022).
cycle of avoidance and a sedentary lifestyle. Therefore, FoF may be Single-item instruments involve direct questioning with yes/no
protective when there is low anxiety, and maladaptive when there questionnaires, for example, "are you afraid of falling?" (Tinetti
is high anxiety. Delbaere 2010 suggested a classification based on 1990) or with Likert scales, for example, "How afraid are you
this mismatch; low or high physiological fall risk, as measured by that you will fall and hurt yourself in the next year?" (Lachman
the physiological profile assessment (Lord 2003), and low FoF (Falls 1998). Alternatively, multi-item indirect instruments to measure
Efficacy Scale – International (FES-I) score of 22 or less for low FoF do so through measuring confidence, in particular falls-
physiological fall risk or 19 or less for high physiological fall risk), or related self-efficacy (Moore 2008). Falls-related self-efficacy in
high FoF. The four possible states are classified as vigorous (low FoF the context of FoF is the confidence to perform an activity
and low fall risk), anxious (high FoF and low fall risk), stoic (low FoF without falling. Multi-item instruments to assess falls-related self-
and high fall risk), and aware (high FoF and high fall risk) (Delbaere efficacy have been found to be more reliable than single-item
2010). instruments (Scheffer 2008). Multi-item instruments are superior to
dichotomous outcomes, allowing the assessment of FoF in both
FoF is common amongst older people, usually defined as aged simple and complex activities in more detail and as a continuum,
65 years and above. Studies in community-dwelling older adults describing a level of FoF. In using single-item questions or multi-
show a FoF prevalence in both genders of 36%, 43% in women, item questionnaires using Likert scaling, FoF can be followed over
and 26% in men (Boyd 2009; Tomita 2018), which increased with time to better identify changes. Questionnaires were developed
age (Lach 2005), and after falls (Lavedán 2018). One cross-sectional based on different concepts of FoF, for example, targeting concerns
study found a prevalence of 43.8% of FoF of people who had not of falling in the FES-I (Yardley 2005), or balance confidence as in
fallen, 66% who had fallen once, and up to 86% in people who the Activities Specific Balance and Confidence Scale (ABC) (Powell
had fallen more than once (Zijlstra 2007). Considering that global 1995), representing the most established assessments strategies
yearly prevalence of falls, as shown in one recent meta-analysis, (Scheffer 2008).
in older adults ranged from 28% to 34%, of which 5% may end in
fractures, there is likely a significant and growing group of people Description of the intervention
who experience falls (Salari 2022). Clemson 2015 found that having
The main therapeutic approaches to treat FoF are currently
an injurious fall does not predict acquiring FoF and that having
represented by exercise interventions and cognitive behavioural
FoF did not predict having an injurious fall; however, FoF has been
therapy (CBT). Exercise interventions are planned, structured,
shown to predict falls when mobility was limited (Litwin 2018).
repetitive, and purposeful physical activities to improve or
Risk factors associated with FoF are female gender, older age, lower maintain one or more components of physical fitness (CDC 2020;
level of education, chronic illness, poor subjective health status,
Informed decisions.
Kendrick 2014), also targeting related health outcomes such as trauma (Adamczewska 2018; Tinetti 1990). The beliefs towards
prevention of falls. falling therefore influence FoF.
CBT interventions, specifically designed to treat FoF, represents Kendrick 2014 suggests that exercise may reduce FoF by directly
a second approach to reduce FoF, and have been positively impacting FoF or indirectly impacting factors associated with FoF
evaluated in one review (Liu 2019). CBT is a class of and the risk of falling. The exercise component in CBT with exercise
psychotherapeutic interventions based on the cognitive theory, interventions is expected to have the same benefits. Exercise is
where an individual's idiosyncratic and maladaptive ideation, often expected to reduce the rate of falls through strength, balance,
called dysfunctional cognitions, and consequently dysfunctional endurance, and stability training, as well as improving mood (Jung
behaviour, are modified, in a process called cognitive restructuring 2008; Kendrick 2014). Exercise may also improve fall-related self-
(Beck 1970). CBT interventions for FoF are psychotherapeutic efficacy (Kendrick 2014).
interventions aimed at modifying individuals' thoughts and
behaviour. This therapeutic approach is to restructure maladaptive Li 2005 hypothesised that the mediator for change in FoF is fall-
behaviour to a more adaptive one (Liu 2019; Tennstedt 1998). related self-efficacy. In following Bandura 2004's social cognitive
CBT is collaborative, time-limited, goal-oriented, and structured. theory, falls efficacy would mediate a decrease in FoF through the
Misconceptions, distortions, and maladaptive assumptions are potentially pleasurable experience of exercise, the social approval
identified, and the validity and reasonableness of the assumptions of pursuing exercise, and the positive self-evaluations of having
tested (Beck 1970). Interventions aim to lower the emotional and successfully completed the exercise. Those with high self-efficacy
behavioural sequela resulting from these dysfunctional cognitions, would therefore likely have low FoF.
by loosening the perseverative and distorted cognitions, and
In combination with CBT approaches, the exercise component
by introducing more realistic ones (Beck 1970). CBT is the
of CBT with exercise interventions may serve as a source
most researched form of psychotherapy, with evidence of
of behavioural experiments, where, through exposure between
efficacy in multiple psychiatric pathologies (Hofmann 2012).
sessions to situations that evoke FoF, the individual acquires
CBT interventions specifically designed for treating FoF focus
experience refuting prior beliefs, or dysfunctional cognitions,
on cognitive restructuring, goal setting, and promoting physical
relating to falling, through performing activities that do not
activities in both one-on-one or group sessions and are given by
result in falls as expected. In considering the PTSD cognitive
specially trained individuals (Liu 2019).
model, behavioural experiments during the exercise component
Another approach to treating FoF is a multicomponent of CBT with exercise interventions would reduce FoF by modifying
intervention, that is, CBT with exercise interventions, where the negative appraisals of the trauma and its sequelae; elaborate
techniques of these individual therapeutic approaches are used the fall-related traumatic memories into context of time, place,
together (Huang 2016; Wetherell 2018). and situation; and drop dysfunctional behaviours and cognitive
strategies (Ehlers 2005).
The first widely implemented CBT with exercise intervention
developed for treating FoF was Tennstedt 1998's "A Matter of Why it is important to do this review
Balance" (AMB) and has been adapted to different languages and
The high prevalence and associated serious adverse health
countries. This time-limited intervention is given in twice-weekly
outcomes make FoF in older adults a major public health issue
group sessions, starting with psychotherapeutic discussions,
(Boyd 2009). FoF is an interdisciplinary challenge encompassing
progressing onto physical exercise, and ending with another
both physical and mental health: primary care providers, such
discussion. A cognitive restructuring approach to changing
as geriatricians or family physicians, would manage mainly the
behaviour is the main therapeutic approach (Tennstedt 1998). The
physical sequelae, whereas mental health providers, such as
group discussions are focused and have a new theme for each
psychiatrists, would respond to the psychological responses to FoF
session. The exercise consists of strength training exercises.
and the resulting vicious cycles leading to psychiatric comorbidity
(Lenouvel 2021). Best available evidence for the effectiveness of
How the intervention might work
treatment addressing both the physical and mental health needs of
Several mechanisms may be involved in reducing FoF in both CBT, individuals with FoF is required.
and CBT with exercise. CBT for FoF aims at modifying dysfunctional
cognitions regarding the risk of falling, and the resulting In addition to updating the literature search, our review
behaviour. The specific cognitive mechanisms maintaining FoF investigated other outcomes, including activity avoidance,
have been linked to those of post-traumatic stress disorder (PTSD), occurrence of falls, depression, anxiety, and adverse outcomes,
where there is a trauma response involving anxiety, loss of aiming to provide a comprehensive overview of the effects of CBT
self-confidence, and activity avoidance (Adamczewska 2018). A or CBT and exercise together, as these outcomes have not been
Multifactorial Causation Model of Falls and Fear has been proposed included in current reviews of CBT interventions for reducing FoF.
linking FoF with appraisals of an individual's ability to maintain These outcomes are selected as they are known to be related to FoF.
balance in relation to other contributors such as falls history
We will also consider the interventions in the context of the need
or beliefs that a person holds regarding falls (Hadjistavropoulos
for a standardised taxonomy to characterise the interventions and
2012). Such an extended model would also help explain the high
to address problems of intervention heterogeneity (variability) in
frequency of FoF in those who have not had a severe fall or any
both research and care for falling (Lamb 2011).
fall in the recent past. The Multifactorial Causation Model of Falls
and Fear suggests that falls efficacy, the belief that one can avoid Our review will complement the Kendrick 2014 Cochrane Review
falling, has a role in stressful situations following exposure to fall on exercise interventions to reduce FoF, as well as establishing
the evidence base of the emerging CBT and combined CBT with
Informed decisions.
exercise approaches. The Cochrane format of ongoing reviewing We defined CBT interventions as interventions given by a
will allow inclusion of emerging new studies to allow an update of professional or trained non-professional therapist that were
evidence found (Moher 2006). delivered in person, or through telecommunications, such as
videoconferencing. The content of the interventions included any
OBJECTIVES therapeutic approaches aimed at modifying maladaptive beliefs
and behaviours. We defined CBT interventions based on a summary
To assess the benefits and harms of CBT for reducing FoF in of six Cochrane Reviews on CBT (Davies 2018; Fuller 2020; Hetrick
older people living in the community, and to assess the effects of 2016; James 2020; Simon 2021; Sneddon 2020). This definition
interventions where CBT is used in combination with exercise. is in line with the Prevention of Falls Network Europe (ProFaNE)
taxonomy for use in fall prevention (Lamb 2011). CBT interventions
METHODS were included in this review when they included all the following.
Criteria for considering studies for this review • The goal of the CBT was changing behaviour.
Types of studies • The CBT component was structured (e.g. there was a protocol to
follow).
We searched for randomised controlled trials (RCTs), quasi-RCTs
(i.e. group allocation based on certain criteria), and cluster-RCTs • The CBT component allowed for interactive discussion.
(if more than one cluster per intervention) assessing CBT with and The CBT intervention was provided by a person trained in
without exercise interventions for FoF versus control. following the intervention protocol, not necessarily a certified
Types of participants psychotherapist. The exercise intervention was delivered either
alongside at the same time, or separately at a different time
Trials were included when all the participants were: by the same or different people, as the CBT component of the
combined intervention. Cognitive restructuring may be used in the
• community-dwelling older adults. Community living was CBT component to test the assumptions or beliefs about FoF of
considered when the places of residence did not provide those undergoing treatment. There may have been a provision of
significant health-related care, such as living at home, recommended exercises without supervision.
retirement villages, or shelters. Trials with mixed populations
were included. Mixed populations are when people living in Interventions combining CBT and exercise combined elements
the community are grouped with people living in places where of both CBT and exercise interventions for FoF. The exercise
increased care is provided, such as assisted living centres or intervention component consisted of physical activities that
nursing homes; were planned, structured, repetitive, and aimed at improving or
• older adults. Although older adults are considered 65 years and maintaining one or more components of physical fitness (CDC 2020;
older, in order to avoid the exclusion of relevant trials, those with Kendrick 2014). We included sham treatments in the comparison
a specified inclusion criterion of 60 years of age or over, or if the group, defined as interventions that were unlikely to have a
mean age minus one standard deviation is more than 60 years substantial impact on physical activity, such as simple lifestyle
were included. advice (Kendrick 2014).
Trials were excluded when: Trials were excluded when they:
• trial population focused on distinct clinical conditions. Distinct • did not fulfil our definition of CBT interventions, as described
clinical conditions involved any special population with a above;
specific ICD-10 (10th revision of the International Statistical • did not include CBT with and without exercise interventions.
Classification of Diseases and Related Health Problems) coded
diagnosis, such as people with stroke, Parkinson's disease, Trials were included when they compared:
osteoporosis, or multiple sclerosis. However, because there
is a high prevalence of multimorbidity, including dementia, • CBT-only interventions for FoF with standard care, or placebo
amongst older adults, we included trials looking at multimorbid or sham treatments. Standard care was defined as no change in
populations living in the community; usual activities (without any additional treatments);
• trial population had moderate (Mini-Mental State Examination • CBT with exercise interventions for FoF with standard care, or
(MMSE) score 11 to 20) or severe (MMSE 0 to 10) dementia placebo or sham treatments.
(Perneczky 2006). Trials where participants had mild cognitive
Studies with placebo or sham treatments that have active
impairment (MCI) or mild dementia (MMSE 21 to 24) were
components were included if there was enough information in the
included. The inclusion of participants with MCI and mild
study report to determine that these were unlikely to influence
dementia takes into consideration that CBT has been shown
behaviour.
effective in that population (Forstmeier 2015).
Types of outcome measures
Types of interventions
Trials assessing FoF and related constructs as primary or secondary
Trials were included when they investigated:
outcomes were included in this review. We collected data
• CBT interventions with and without exercise interventions. for the primary outcome at three time points: immediately
postintervention, up to and including six months after treatment,
and more than six months after treatment; these latter
Informed decisions.
two time points demonstrate sustainability of the effect of • Cochrane Central Register of Controlled Trials (CENTRAL, Issue
the intervention. For secondary outcomes, we only reported 1, 2023) via the Cochrane Register of Studies (CRS-Web)
immediate postintervention effects. • MEDLINE Ovid (from 1946 to 11 January 2023)
Primary outcomes • Embase Ovid (from 1980 to 11 January 2023)
• CINAHL Plus (Cumulative Index to Nursing and Allied Health
• FoF. As an umbrella term, FoF is documented by different Literature) (from 1982 to 11 January 2023)
assessment methods focusing on concepts related to emotional
• PsycINFO (from 1967 to 11 January 2023)
(fear) as well as cognitive appraisal (concerns). FoF can be
measured through single-item questionnaires, or through multi- • AMED (Allied and Complementary Medicine from 1985 to 11
item measures, such as those for falls efficacy, and balance January 2023)
confidence. Relevant measurement tools to identify FoF are There were no limitations based on language or publication status
summarised by Kendrick 2014 and Moore 2008. These are: during the initial search. However, only English and German
◦ ABC and its associated versions (e.g. its UK version ABC-UK) language articles were considered for inclusion, due to the
(Powell 1995) language abilities of the review authors.
◦ Falls Efficacy Scale (FES) (Tinetti 1990) and its associated
versions (e.g. modified FES (mFES) (Hill 1996), or FES-I) In MEDLINE, we combined the subject-specific terms with the
(Yardley 2005) sensitivity-maximising version of the Cochrane Highly Sensitive
◦ Geriatric Fear of Falling Measure (GFFM) (Huang 2006) Search Strategy for identifying randomised trials (Lefebvre 2019).
◦ Single-item Instruments (Tinetti 1990; Howland 1993) The search strategies are provided in Appendix 1.
◦ Mobility Efficacy Scale (MES) (Lusardi 1997) We also searched the following trials registries to identify ongoing
◦ University of Illinois at Chicago Fear of Falling Measure and recently completed trials.
(UICFFM) (Velozo 2001)
• The World Health Organization International Clinical Trials
Secondary outcomes Registry Platform (WHO ICTRP) (11 January 2023)
• Activity avoidance (direct questions or questionnaires, such • ClinicalTrials.gov (11 January 2023)
as the Survey of Activities and Fear of Falling in the Elderly
Searching other resources
(SAFFE) (Lachman 1998) or the Falls Efficacy Scale-International
Avoidance Behaviour (FES-IAB) (Dorresteijn 2016)) We searched reference lists of included articles for relevant
• Occurrence of falls (number of fallers/rate of falls) (Hauer 2006; articles. We contacted experts in the field for relevant published
Lamb 2005) or unpublished studies. We handsearched the conference
• Depression (any validated depression-related questionnaire, proceedings of International Conference on Fall Prevention and
e.g. Beck Depression Inventory-II (BDI-II)) (Beck 1996) Protection (ICFPP) from 2010 to 2022.
• Anxiety (any validated anxiety related questionnaire, e.g. Beck Data collection and analysis
Anxiety Inventory (BAI)) (Beck 1988)
• Adverse effects, such as development of new symptoms, Review authors previously or currently involved in conducting a
distress, or emotional disturbances during intervention study that was potentially eligible for inclusion in the review were
(Schermuly-Haupt 2018) exempt from study selection decisions, risk of bias assessments,
and data extraction for their study.
• Quality of Life (QoL) encompassing related concepts of
functional status, health-related QoL, and well-being. Examples Selection of studies
of relevant measurement tools to identify QoL are:
◦ 36-item Short Form Health Survey (SF-36) (Ware 1980) Two review authors (EL and PU) independently screened titles
◦ World Health Organization Quality of Life-BREF (WHOQOL- and abstracts retrieved from the database searches against the
BREF) (Skevington 2004) inclusion and exclusion criteria using the online screening and
data extraction tool Covidence (Covidence). We screened the full
◦ Personal Well-Being Index (PWI) (Cummings 2002)
texts of the remaining articles. We resolved disagreements for the
◦ Satisfaction with Life Scale (SWLS) (Diener 1985) inclusion or exclusion of titles and abstracts, or study inclusion
◦ Life Satisfaction Questionnaire-9 (LISAT-9) (Fugl-Meyer 1991) between the pairs of review authors. When there was no consensus,
• Burden of treatment (as per the cost of treatment, time an independent advisor group (SK, KH, GK, RZ) resolved conflicts.
spent treating, participant time receiving treatment), and When clarification was required to assess eligibility, we contacted
compliance (reported adherence to exercises and presence the corresponding authors of the article in question.
during psychotherapy)
Data extraction and management
Search methods for identification of studies Two review authors (EL and PU) independently extracted data
Electronic searches using an electronic version of a standardised data extraction
form for intervention reviews modified to include primary and
Using tailored search strategies, we searched the following secondary outcome data. This form was managed in an electronic
electronic databases for relevant trials with the main search spreadsheet. The review authors discussed disagreements in data
conducted in March 2021, updated in November 2021 in a second extraction. When there was no consensus, an independent advisor
search, and updates on 11 January 2023 in a third search. group (SK, KH, GK) resolved conflicts. We piloted the data extraction
Informed decisions.
form on two studies. We considered studies with multiple reports as Unit of analysis issues
a single study. We contacted study authors to request missing data.
Unit of analysis issues occur when the number of observations in
The standardised data extraction form was based on that of The the analysis do not match the number of units that are randomised,
Cochrane Developmental, Psychosocial and Learning Problems typically occurring in cluster-randomised trials (Higgins 2019).
Review Group, as published on their website (Cochrane 2022). When studies did not account for clustering in their analysis,
an intracluster correlation coefficient (ICC) was estimated of r =
Assessment of risk of bias in included studies 0.02 and the sample size was adjusted accordingly (Killip 2004)
for the effective sample size. In taking a conservative approach,
Two review authors (EL, PU) independently assessed the risk of
we rounded values down, as per Chapter 23 of the Cochrane
bias of included studies using the Cochrane RoB 1 tool, providing
Handbook for Systematic Reviews of Interventions (Deeks 2022).
a domain-based evaluation, as described in Chapter 8 of the
Studies that presented results over several time periods created
Cochrane Handbook for Systematic Reviews of Interventions (Higgins
unit of analysis error (Higgins 2019). For this reason, we based
2011). The forms were managed in an electronic spreadsheet.
outcomes in time frames. Caution was taken to avoid analysing
We assessed the domains of sequence generation, allocation
count data as dichotomous data, which occurs when outcomes are
concealment, blinding of participants and personnel, blinding
reported as number of events, such as number of falls, rather than
of outcome assessments, incomplete outcome data, selective
number of participants with these outcomes (Higgins 2019). When
outcome reporting, and other potential threats of validity. We
studies had multiple experimental arms, and were not a cross-over
contacted corresponding study authors to request any missing
design, each arm with a CBT component was given proportional
information required to classify risk of bias. We resolved
weight, as described in the data synthesis. If cross-over trials are
disagreements in the assessment of risk of bias between review
identified in future updates, they will be handled as described in
authors. When there was no consensus, an independent advisor
Chapter 23 of the Cochrane Handbook for Systematic Reviews of
group (SK, KH, GK, RZ) resolved conflicts. Whenever we obtained
Interventions (Deeks 2022).
missing data from study authors, we documented this in the risk of
bias table. We considered studies to have an overall high risk of bias Dealing with missing data
when at least three domains were at high risk, or if there was at least
one unclear and one high risk in the other domains. Missing data were dealt with following the recommendations of the
Cochrane Handbook for Systematic Reviews of Interventions (Deeks
Specifically for trials using cluster randomisation, we considered 2019). We calculated standard deviation (SDs) for continuous
the additional risk of bias relating to recruitment, baseline outcomes when not reported based on standard errors, CIs, or
imbalance, loss of clusters, incorrect analysis, and comparability exact probability (P) values. We contacted study authors to request
with individually randomised trials, as described in Chapter 16 information where missing data could not be calculated from the
of the Cochrane Handbook for Systematic Reviews of Interventions information given. We did not impute missing SDs.
(Higgins 2011). Particular attention was given to the randomisation
and blinding processes (Eldridge 2016). Assessment of heterogeneity
We assessed statistical heterogeneity using the Chi2 test,
Measures of treatment effect
considering a low P value (less than 0.1) as statistical evidence of
We reported continuous data using the mean difference (MD) heterogeneity of intervention effects (Deeks 2019). We calculated
with 95% confidence intervals (CI) when studies used the same inconsistencies across studies using the I2 statistic, testing the
outcome measures and standardised mean difference (SMD) when impact of the heterogeneity (Deeks 2019). All calculations used
studies used different measures for the same clinical outcome. Review Manager 5 (Review Manager 2014). We interpreted results
For continuous outcomes, we presented final scores in preference as suggested by Higgins 2019.
to change scores. Where appropriate, we combined change
scores with post-treatment scores. For dichotomous outcomes, we • 0% to 40%: heterogeneity might not be important
reported treatment effects as risk ratios (RR), with 95% CIs. We • 30% to 60%: may represent moderate heterogeneity
interpreted outcomes presented as SMDs as having small effect • 50% to 90%: may represent substantial heterogeneity
sizes for SMD values of 0.2 or greater, medium effect sizes as 0.5
• 75% to 100%: considerable heterogeneity
or greater, and large effect sizes as 0.8 or greater in line with the
Cochrane Handbook for Systematic Reviews of Interventions (Higgins Comparisons of participant characteristics and methodology of
2011). included studies allowed for the evaluation of the clinical and
methodological diversity. Visual inspection of forest plots was
We considered a one-month measurement period following the
performed to identify overlapping 95% CIs for consistency of
end of the intervention for the postintervention effects due to
intervention effects.
the logistics of measuring study participants. We chose sustained
FoF change time points representing short-term sustainability Assessment of reporting biases
(over one month to up to and including six months), and long-
term sustainability (over six months). Sustainability of effects was We assessed publication biases using funnel plots where there were
dichotomised at less than six months and six months or greater as more than 10 studies available. Visual inspection for asymmetry
it was considered clinically relevant. was performed to identify the presence of potential bias.
Data synthesis
Analysis of synthesised data followed the recommendations of the
Cochrane Handbook for Systematic Reviews of Interventions (Deeks
Informed decisions.
2022). All calculations were performed using Review Manager 5 Four a priori subgroup analyses (baseline fall risk, baseline FoF,
using data extracted from the included articles, or obtained directly cognitive state, and sex) were not undertaken for reasons explained
from study authors (Review Manager 2014). in the Differences between protocol and review section.
When considered appropriate, we pooled the results of comparable When there were common trends in interventions that were
studies using both fixed-effect and random-effects models. We deemed clinically relevant, we conducted post hoc analyses. Post
reported random-effects models as primary analyses, due to hoc analyses were:
their plausible assumptions in medicine, as well as extent of
heterogeneity between studies. We included fixed-effect models in • CBT only versus CBT with exercise interventions;
the sensitivity analysis. In studies with multiple arms, we included • interventions based on AMB versus non-AMB-based
each arm fulfilling the inclusion criteria (e.g. CBT with and without interventions;
exercise interventions). We used the number of participants of each • group versus individual interventions.
of the corresponding intervention arms, divided the number of
participants in the control group by the number of included arms Sensitivity analysis
of the study. Studies with multiple arms were used throughout.
We performed a priori sensitivity analysis for the primary outcome
We did not consider pooling data where there was considerable
for:
heterogeneity (I2 ≥ 75%) that could not be explained by the
diversity of methodological or clinical features amongst trials. • removing the studies causing considerable heterogeneity
Where pooling data was inappropriate, we presented trial data in (outliers);
the analyses or tables descriptively and reported these in the text.
• trials with high risks of bias (i.e. with at least three domains at
We assessed FoF postintervention and to determine sustainability high risk of bias);
of effect. The postintervention effect is the change in FoF values • comparing fixed-effect and random-effects estimates.
as measured upon completion of the intervention. Sustainability
is "the maintenance of health benefits over time and improving One a priori sensitivity analysis (quasi-RCTs) was not undertaken for
appraisal of existing programs (Shediac-Rizkallah 1998; Lennox reasons explained in the Differences between protocol and review
2020)." We measured sustainability at two time points – up to section.
six months after the intervention and later than six months. We When there were common trends in studies observed in
re-expressed the SMD of the primary outcomes using the FES-I, interventions that were deemed subject to potentially influence
calculating the baseline pooled SD of a study whose population quantitative synthesis, we performed post hoc sensitivity analysis
was representative of the those included in this review, with the for the primary outcome for:
formula from the Cochrane Handbook for Systematic Reviews of
Interventions (Deeks 2022). • trials where FoF was not the primary outcome;
During the review process, we noted differences in intervention • where non-FES-based questionnaires were used as measures;
type according to whether exercise was included with CBT. For all • clustered trials for potential ICC issues;
outcomes, we presented data separately for CBT with and without • trials where active control groups were used.
exercise interventions in order to better demonstrate the variation
between intervention approaches; we also presented a pooled Summary of findings and assessment of the certainty of the
effect estimate for all intervention approaches. evidence
We prepared Summary of findings 1 for CBT interventions (CBT
When studies reported several measures for FoF, preference
with and without exercise) compared to control for reducing FoF in
was given for the FES-I or its derivatives (e.g. modified Falls
older people living in the community, listing the outcomes of FoF,
Efficacy Scale (mFES), FES, Falls Efficacy Scale Swedish variant
immediate postintervention effects; sustainability of effects, up to
(FES-S)). Preference was given to the FES-I as it was the most
six months' postintervention; sustainability of effects, more than
used FoF measuring instrument amongst the included studies
six months' postintervention; postintervention effects for activity
and is the recommended fall-related psychological measure for
avoidance, occurrence of falls, depression, and adverse effects. We
falls efficacy (Moore 2008). This follows the ProFaNE consensus
used GRADEpro software to produce the table (GRADEpro GDT).
recommendation that psychological consequences of falls should
be conceptualised in terms of falls-related self-efficacy (Lamb We used the GRADE approach to assess the certainty of evidence.
2005). The certainty of the evidence is rated according to four categories:
high, moderate, low, and very low (Schünemann 2019). The
Subgroup analysis and investigation of heterogeneity
decision to define the certainty of evidence is based on five
We selected subgroup characteristics a priori due to their known domains for downgrading (risk of bias, inconsistency, indirectness,
association with FoF, or influence on the course of intervention imprecision, publication bias), with the certainty of evidence
outcomes. We performed the following a priori subgroup analyses. initially being rated at high, as all included studies were RCTs (Deeks
2022). A high grade indicates that we are "very confident that the
• Age group (aged less than 75 years versus aged 75 years or true effect lies close to that of the estimate of the effect;" moderate
greater) grade that we are "moderately confident in the effect estimate:
• Type of control group (placebo control versus usual care control) the true effect is likely to be close to the estimate of the effect,
but there is a possibility that it is substantially different;" low that
"confidence in the effect estimate is limited: the true effect may be
Informed decisions.
substantially different from the estimate of the effect;" and very Once duplicates had been removed, we had 4938 records. We
low that we "have very little confidence in the effect estimate: the excluded 4866 records based on titles and abstracts. We obtained
true effect is likely to be substantially different from the estimate of the full text of the remaining 72 records and linked any references
effect" (Schünemann 2019). pertaining to the same study under a single study ID. Upon further
analysis, we excluded 57 studies of which the 24 most potentially
RESULTS relevant excluded studies are described in the Characteristics
of excluded studies table. There are three ongoing studies (see
Description of studies Characteristics of ongoing studies table).
Results of the search
We included 12 studies reported in 15 references (Arkkukangas
We screened 8060 records from the following databases: CENTRAL 2019; Dorresteijn 2016; Freiberger 2012; Freiberger 2013; Gitlin
(1492), MEDLINE (1327), Embase (2007), CINAHL (544), PsycINFO 2006; Huang 2011; Parry 2016a; Reinsch 1992; Resnick 2008;
(1168), AMED (504), the WHO International Clinical Trials Registry Tennstedt 1998; Wetherell 2018; Zijlstra 2009). For a further
Platform (415), and ClinicaTtrials.gov (603). Our searches of the description of our screening process, see the study flow diagram
reference lists of included studies found one additional study that (Figure 1).
was not retained for inclusion in the meta-analysis.
Informed decisions.
Figure 1. Study flow diagram.
8060 records 1 additional record

identified through identified through
database searching other sources
4938 records after

duplicates removed
4938 records 4866 records

screened excluded
57 full-text articles
excluded, due to
ineligibility with
predefined
inclusion/exclusion
criteria for:
• 18 intervention
72 full-text articles • 21 study design
assessed for • 8 population
eligibility • 3 language not
English or German
• 1 preliminary results
of a retained study
• 1 duplicate study
data publication
• 5 control group
3 ongoing trials
12 studies included
in qualitative
synthesis
11 studies included
in quantitative
synthesis
(meta-analysis)
Informed decisions.
Included studies 2012; Freiberger 2013; Parry 2016a; Tennstedt 1998; Wetherell
2018; Zijlstra 2009). Inclusion and exclusion criteria of the studies
Design
are listed in the Characteristics of included studies table. Studies
Of the 12 included studies, eight studies were individually included community-dwelling, relatively healthy, and mobile older
randomised controlled trials (RCTs), and four were cluster-RCTs people without cognitive impairment.
(Freiberger 2013; Reinsch 1992; Resnick 2008; Tennstedt 1998).
The study characteristics are summarised in Table 1. There were All but three studies reported baseline fall rates (Gitlin 2006; Parry
no quasi-experimental trials. Most studies were two-armed RCTs 2016a; Resnick 2008). Most studies stratified participants according
(intervention versus control), except for Arkkukangas 2019 (three- to baseline fall history – no falls, one fall, or more than one fall.
armed RCT), Huang 2011 (three-armed RCT), Freiberger 2012 (four- We dichotomised baseline fall rate as non-fallers and fallers (fallen
armed RCT), and Reinsch 1992 (four-armed RCT). Arkkukangas 2019 once or more) by adding single and multiple fallers. Tennstedt
had a CBT with exercise arm, an exercise only arm, and a control 1998 reported 24.9% of participants with at least one fall in the
arm. Huang 2011 had a CBT only arm, a CBT with exercise arm, and last three months before baseline. Dorresteijn 2016 had 62.2% and
a control arm. Freiberger 2012 had two exercise only arms, one CBT Zijlstra 2009 55.6% of participants falling in the previous six months.
with exercise arm, and a control arm. Reinsch 1992 had a CBT alone Arkkukangas 2019 reported 43.2% and Wetherell 2018 64.3% in
arm, CBT with exercise arm, exercise alone arm, and control arm. the last 12 months. Alternatively, studies stratified by falls versus
For purposes of this review, we included the CBT only, CBT with no falls in past six months (Freiberger 2012: 26.1%) or 12 months
exercise, and control arms from the three and four-armed studies. (Freiberger 2013: 52.3%; Huang 2011: 17.8%). Reinsch 1992 used
the term previous fallers without specifying a timeline (27.1%).
Aim The percentage of fallers before the intervention was calculated
as the mean between intervention and control groups. The overall
The primary aim of 10 studies was to investigate the effectiveness of
weighted mean rate of fallers of all included studies reporting
reducing FoF (Arkkukangas 2019; Dorresteijn 2016; Freiberger 2012;
baseline fall rates was 44.4% and the median was 43.2%. Tennstedt
Gitlin 2006; Huang 2011; Parry 2016a; Resnick 2008; Tennstedt 1998;
1998 was not included in the calculation for mean and median
Wetherell 2018; Zijlstra 2009). The primary aim of Reinsch 1992 was
percentage of fallers in the baseline characteristics, as this study
to investigate the length of time to first fall and the severity of injury
was not included in quantitative synthesis.
associated with the fall; FoF was a secondary outcome. The primary
aim of Freiberger 2013 was to reduce falls and injurious falls. Interventions
Sample sizes The interventions fell into two categories: CBT only (Huang 2011;
Parry 2016a; Reinsch 1992), and CBT with exercise (Arkkukangas
The 12 included studies involved 3197 participants in both the
2019; Dorresteijn 2016; Freiberger 2012; Freiberger 2013; Gitlin
control groups (total 1544) and intervention groups (total 1653),
2006; Huang 2011; Reinsch 1992; Resnick 2008; Tennstedt 1998;
of whom 2357 (control 1119, intervention 1238) were included for
Wetherell 2018; Zijlstra 2009). Two studies had both a CBT only arm
quantitative synthesis, before adjusting for clustering. Study total
and a CBT with exercise arm that fulfilled the inclusion criteria for
sample sizes varied from 42 (Wetherell 2018) to 540 participants
inclusion in this review (Huang 2011; Reinsch 1992).
(Zijlstra 2009).
Details of intervention
Setting
Three interventions were reported to be directly adapted from or
The studies were based in six different countries (USA = 5; Germany to take elements of the AMB (Dorresteijn 2016; Freiberger 2012;
= 2; the Netherlands = 2; Sweden = 1; Taiwan = 1; UK = 1). One study Zijlstra 2009). The interventions focused on using the technique
was an international collaboration between Germany, the USA, and of cognitive restructuring, goal setting, and encouraging the
the Netherlands (Freiberger 2012). pursuit of activities between sessions in groups while focusing on
positive aspects of the exercise. The adaptations to AMB were:
Participants
Dorresteijn 2016 translated AMB to Dutch and provided a home-
No study noted differences in their baseline sample populations. based individual intervention with a motivational interviewing
All studies recruited both sexes. Mean age of recruited participants component for establishing an individualised exercise component.
at baseline varied between 73 (Resnick 2008) and 83 years The exercise component focused on setting realistic personal goals
(Arkkukangas 2019), with one study not reporting the mean age for increasing activity levels and safe behaviour (using action plans,
(Huang 2011). The median age of studies included in quantitative promoting uptake of old and new activities, and exposure in vivo).
synthesis was 77.9 years. The median consisted of all studies except Dorresteijn 2016 was a CBT with exercise intervention, as the
for Huang 2011, who reported baseline age in ranges (60 to 64 intervention attempted to plan and structure repetitive purposeful
years and 65 years or greater) rather than overall mean. Only physical activities though focusing on activities that were no longer
Resnick 2008 had a mean age of participants of less than 75 years, pursued due to the FoF; Freiberger 2012 used the fall risk education
and only Arkkukangas 2019 had participants with a mean age of component from AMB and added a cognitive training component;
more than 80 years. Five studies recruited populations greater Zijlstra 2009 adapted the intervention to allow for scheduling more
than 60 years of mean age (Huang 2011; Parry 2016a; Reinsch time for some activities, changing session frequency from twice to
1992; Resnick 2008; Tennstedt 1998), two greater than 65 years once a week, adding a booster session after six months, and adding
(Freiberger 2013; Wetherell 2018), and five greater than 70 years more transparencies.
(Arkkukangas 2019; Dorresteijn 2016; Freiberger 2012; Gitlin 2006;
Zijlstra 2009). In seven studies, fall experience or the presence Despite elements overlapping with AMB, other CBT interventions
of FoF was an inclusion criterion (Dorresteijn 2016; Freiberger treated FoF differently. Arkkukangas 2019 used interactive
motivational interviewing structured using open-ended questions,
Informed decisions.
affirmations, reflective listening, and summaries (OARS). Freiberger hours; Huang 2011 had 8 to 12 hours; Dorresteijn 2016 had 15.5
2013 was adapted for improvement from Freiberger 2012, following hours; Freiberger 2013, Tennstedt 1998, and Zijlstra 2009 had 16
the outcomes of their study. Freiberger 2013 developed a fall risk hours; Resnick 2008 had 12 to 18 hours; and Freiberger 2012 had
education component that addressed misconceptions about fall 32 hours. Intervention intensity varied from three times weekly
risk, attitudes about falls, thoughts, and concerns about falling; (Reinsch 1992), twice weekly (Resnick 2008; Tennstedt 1998),
negative and positive thinking patterns; identifying potential weekly (Freiberger 2012; Freiberger 2013; Huang 2011; Parry 2016a;
environmental fall hazards; and dedicated sessions for behavioural Wetherell 2018; Zijlstra 2009), every two weeks (Arkkukangas 2019;
changes and attitudes. Gitlin 2006 used the cognitive approach Dorresteijn 2016), and monthly (Gitlin 2006). Interventions were
of problem-solving and reframing. Huang 2011 developed an given for 8 weeks (Huang 2011; Parry 2016a; Tennstedt 1998;
intervention focusing on restructuring misconceptions to promote Zijlstra 2009), 12 weeks (3 months) (Arkkukangas 2019; Resnick
a view of fall risk and FoF as controllable through discussions 2008), 16 weeks (4 months) (Dorresteijn 2016; Freiberger 2012;
about the associations with falls or FoF. Participant's point of Freiberger 2013), 24 weeks (6 months) (Gitlin 2006), and 48 weeks
view of FoF (positive and negative aspects about the topic), (12 months) (Reinsch 1992). Details of compliance with exercise and
strategies to manage FoF and family support and implementing psychotherapy components of treatment were lacking amongst the
it in the participant's daily life, and problem-solving (during a included studies.
fall learning how to fall, stand up, and call for help) (Huang
2011). Parry 2016a examined the three Ps model (predisposing, Therapist backgrounds
precipitating, and perpetuating) in more detail, formulating the FoF Therapists providing CBT were healthcare professionals of various
schema. Identified problems were managed using standard non- specialities; physiotherapists (Arkkukangas 2019; Freiberger 2013;
specific CBT approaches (e.g. graded exposure for anxiety; activity Gitlin 2006; Wetherell 2018), nurses (Dorresteijn 2016; Huang
monitoring, graded activity and behavioural activation for pain, 2011; Zijlstra 2009), trained "fall prevention instructors" (Freiberger
fatigue, and low mood; and sleep management for fatigue) (Parry 2012), sports scientists (Freiberger 2013), occupational therapists
2016a). (Gitlin 2006), licenced psychotherapists (Parry 2016a), nutritionists
(Resnick 2008), or trained laypeople (Resnick 2008; Tennstedt
Reinsch 1992 used a cognitive behavioural approach to 1998). Wetherell 2018 had a novel approach of providing
improve awareness of environmental hazards and medically physiotherapists with supervision from licenced psychotherapists.
related risk factors, through fall prevention education, improve
confidence, and lower anxiety, through relaxation training (Reinsch Controls
1992). Resnick 2008 developed the Senior Exercise Self-efficacy
Project (SESEP). This intervention used exposure to enactive Control groups were mostly usual care (no interventions)
mastery experiences (participating in an exercise class), verbal (Arkkukangas 2019; Dorresteijn 2016; Freiberger 2012; Freiberger
encouragement (counselling and education), and "implementation 2013; Gitlin 2006; Huang 2011; Parry 2016a; Zijlstra 2009).
of interventions to decrease the unpleasant sensations or augment Other control groups (placebo controls, considered active control
the pleasant sensations associated with exercise" to enhance falls- groups) consisted of a non-FoF-related discussion group (Reinsch
related self-efficacy beliefs and modify outcome expectations. 1992), nutrition education (Resnick 2008), social contact and
Wetherell 2018 developed the Activity, Balance, Learning, and non-FoF-related discussion groups (Tennstedt 1998), and fall
Exposure (ABLE) intervention. The CBT component was given prevention education (Wetherell 2018). Fall prevention education
during the fifth to seventh week and consisted of "psychoeducation was considered a sham treatment, as the education in the context
about anxiety and the role of avoidance, creation of a fear hierarchy of Wetherell 2018 was designed to be an attention placebo.
based on identified triggers and avoidance behaviours, exposure
Outcomes
practise, cognitive restructuring, and problem-solving" while using
exposure techniques (Wetherell 2018). All studies reported FoF outcomes, measured using six different
instruments; we described these in Table 2. Huang 2011 reported
Delivery of intervention sustainability of effects at two and five months. Freiberger
Details of interventions are listed in the Characteristics of included 2012, Gitlin 2006, Tennstedt 1998, and Zijlstra 2009 reported
studies table. All interventions were guided, and five were sustainability measures at six months. Dorresteijn 2016, Freiberger
individualised treatments (Arkkukangas 2019; Dorresteijn 2016; 2012, Parry 2016a, Tennstedt 1998, and Zijlstra 2009 reported
Gitlin 2006; Parry 2016a; Wetherell 2018), while other studies sustainability measures at 12 months. Arkkukangas 2019 and
used group interventions, with mostly between five and 15 Freiberger 2012 reported sustainability measures at 24 months.
participants. Huang 2011 reported up to 12 participants per group, Freiberger 2013 reported 24-month sustainability measures in a
Freiberger 2012 and Freiberger 2013 reported 15 participants, secondary publication. Outcome data were available for most
and Reinsch 1992 reported 25 participants. Zijlstra 2009 reported secondary outcomes, except adverse effects and cost of treatment,
mean group sizes of 10 participants, and Tennstedt 1998 reported for which no studies explicitly reported data.
11 participants. Resnick 2008 reported a mean group size of 17
participants (as calculated by 100 participants over six sites). Only Tennstedt 1998 could not be included in quantitative
Reinsch 1992 had the greatest variation of group size of between synthesis, as it did not report sufficient data. They reported mean
five and 25 participants. change scores, with effect sizes missing in the control groups. We
contacted the study authors who reported they no longer had
Duration and intensity of interventions access to the data. Freiberger 2012 did not report sufficient data
for inclusion; however, when contacted, they provided mean and
Therapist contact time varied between six hours (Arkkukangas
SD values of the ABC scores so that the study could be included.
2019) and 156 hours (Reinsch 1992). Parry 2016a had a total
Wetherell 2018 did not provide sufficient information in their
of 6.75 hours; Gitlin 2006 had 7.5 hours; Wetherell 2018 had 8
Informed decisions.
text; however, we could extract the data from their figures, which programme (using components from the StandingTall Balance
showed mean and standard errors of the FES-I scores. Confidence study) for reducing FoF to community living
older adults (ACTRN12621000440820). This study recruited 189
Sources of funding participants and is expected to finish collecting data by July 2023
All studies declared their sources of funding, and no study declared (www.neura.edu.au/project/own-your-balance/).
conflicts of interest.
NCT05192408 is a multicomponent intervention RCT for reducing
Excluded studies FoF in community-dwelling older adults that began recruitment in
January 2022. The primary outcome of this trial is FoF measured
We excluded 60 articles on inspection of the full text because they using the short FES-I. The secondary outcomes are number of falls
did not meet our inclusion criteria (see Figure 1). We reported in and physical activity measured using the Incidental and PlannEd
the review details of 24 key excluded studies in the Characteristics activity Questionnaire – Weekly Average (IPEQ-WA). The study plans
of excluded studies table. The key excluded studies did not fulfil on recruiting 420 participants, and is expected to be finished in May
inclusion criteria due to an ineligible intervention type, as their 2023.
intervention did not fulfil our definition of CBT (seven studies:
Azizan 2015; Brouwer 2003; Dattilo 2014; Gill 2020; Johansson Taylor 2021 is comparing motivational interviewing (MI) with
2018; Lim 2023; van Schooten 2021), or did not have a CBT standard care in community-dwelling older adults after hip fracture
component (five studies: Headley 2014; Kwon 2011; Lee 2013; Lin (MIHip trial). The primary outcome of this trial is changes in daily
2007; Suttanon 2018); study design (seven studies: Banez 2008; time spent walking; however, one of several secondary outcomes
Chen 2014; NCT01268657; Sartor-Glittenberg 2018; Thiamwong is FoF measured using the FES. Although the intervention is MI,
2019; Walters 2018; Wolfe 2018); and control group (five studies: it is considered to be a CBT intervention, as its goal is to change
Duenas 2019; IRCT20211201053248N1; Liu 2014; NCT02727374; behaviour, there is a protocol to follow, it is designed to allow for
NCT03211429). interactive discussion, and delivered by trained therapists. The trial
recruited around 270 participants. Data collection is expected to be
Studies awaiting classification completed by 2023.
There are no studies awaiting classification.
Risk of bias in included studies
Ongoing studies The findings of the risk of bias assessment are presented in Figure
Three studies are likely to fulfil inclusion criteria but were not 2 (risk of bias summary) and Figure 3 (risk of bias graph). Detailed
included in this review as they are still ongoing. findings are reported in the Characteristics of included studies
table.
The Own your Balance Study is a three-armed RCT investigating
eHealth options to provide a CBT with a tailored exercise
Informed decisions.
Figure 2. Risk of bias summary: review authors' judgements about each risk of bias item for fear of falling outcomes
of each included study.
Blinding of participants and personnel (performance bias): All outcomes

Blinding of outcome assessment (detection bias): All outcomes
Incomplete outcome data (attrition bias): All outcomes
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Selective reporting (reporting bias)

Other bias
Arkkukangas 2019 + + − ? + + +
Dorresteijn 2016 + + − ? + + +
Freiberger 2012 + + − ? + + +
Freiberger 2013 + − − − + + +
Gitlin 2006 + + − ? + ? +
Huang 2011 + + − ? + ? +
Parry 2016a + + − − − + +
Reinsch 1992 ? ? − − − ? ?
Resnick 2008 + + − ? − ? ?
Tennstedt 1998 ? ? − ? + ? −
Wetherell 2018 + + − ? + ? ?
Zijlstra 2009 + + − ? + + +
Informed decisions.
Figure 3. Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages for
fear of falling outcomes across all included studies.
Random sequence generation (selection bias)

Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias): All outcomes
Blinding of outcome assessment (detection bias): All outcomes
Incomplete outcome data (attrition bias): All outcomes
Selective reporting (reporting bias)
Other bias
0% 25% 50% 75% 100%
Low risk of bias Unclear risk of bias High risk of bias
Allocation unclear risk of bias. Tennstedt 1998 was at unclear risk of bias
as they blinded the assessors, but outcomes were self-reported
Random sequence generation
by participants who knew their group allocation. For two trials,
All studies reported random allocation of participants to the authors reported that outcome assessors were not blinded to
intervention and control groups. We judged the risk of bias in group allocation (Freiberger 2013; Parry 2016a), and Reinsch 1992
random sequence generation to be low in 10/12 studies as the did not report whether the outcome assessor was blinded, and
method of random sequence generation was clearly described. It did not report specific statistical analysis considering cluster-
was unclear in two studies as the exact method was not described randomisation, so we classified these studies at high risk of bias for
(Reinsch 1992; Tennstedt 1998). No study had a high-risk rating. this domain.
Allocation concealment Incomplete outcome data

Nine studies had a low risk of allocation concealment, showing Nine trials were at low risk of attrition bias due to low or balanced
that participants and investigators could not foresee assignments. dropout rates or adequately described intention-to-treat analyses
One study was at high risk of bias for allocation concealment with missing data imputation. Three studies were at high risk of bias
as the cluster randomisation procedure was conducted prior to due to high dropout rates and no missing data imputation (Parry
recruitment and inclusion of participants, leading to identification/ 2016a; Reinsch 1992; Resnick 2008).
recruitment bias (Freiberger 2013). Two studies with cluster
randomisation were at unclear risk of bias as the timing of the Selective reporting
randomisation and the inclusion of participants was not specified Six trials reported all prespecified outcomes in the trial registration
(Reinsch 1992; Tennstedt 1998). or protocol, so we judged them at low risk of reporting bias
(Arkkukangas 2019; Dorresteijn 2016; Freiberger 2012; Freiberger
Blinding
2013; Parry 2016a; Zijlstra 2009). We judged the risk of bias to
Performance bias be unclear in the other six trials because the study protocol was
not published, and verification of preplanned analyses was not
For psychological interventions, it is difficult to blind participants
possible (Gitlin 2006; Huang 2011; Reinsch 1992; Resnick 2008;
and therapists to the intervention being provided. None of the trials
Tennstedt 1998; Wetherell 2018).
reported blinding of participants or personnel providing therapies.
Therefore, for the domain of performance bias, we considered all Other potential sources of bias
12 studies at high risk of bias.
Nine studies had low risk of other bias. Three studies were at
Detection bias unclear risk of other bias (Reinsch 1992; Resnick 2008; Wetherell
2018). Reinsch 1992 had a disproportionate ratio of females to
All outcome measurement instruments were appropriate. The
males in the control group compared to the intervention groups
assessment of FoF and the secondary outcomes of depression,
and did not adjust analyses for clustering. Resnick 2008 also did
anxiety, and QoL tend to be assessed from the subjective
not adjust for clustering. Wetherell 2018 only partly reported their
participant's perspective, and rely on self-reports by participants
outcomes in figures within the manuscript. As this reduces the
who know their group allocation, which leads to a judgement
usability of the published data and introduces a potential margin of
of some concerns. Measures were self-reported, and as such
error by having to extract the data from figures, this study was rated
impossible to blind. However, eight trials minimised the likelihood
at unclear risk of other sources of bias. One study had a high risk
of observer bias by blinding the outcome assessors, during
of other bias due to incomplete outcome data and non-transparent
data analysis, to group allocation, and no study reported
reporting of intention-to-treat analyses and analyses for compliant
unsuccessful blinding of assessors (Arkkukangas 2019; Dorresteijn
subgroups (Tennstedt 1998). Additionally, Tennstedt 1998 did not
2016; Freiberger 2012; Gitlin 2006; Huang 2011; Resnick 2008;
Wetherell 2018; Zijlstra 2009). Hence, these trials were judged at
Informed decisions.
adjust for clustering. This lack of reported outcomes prevented this −0.36 to −0.07; I2 = 53%; 10 studies, 1885 participants; Analysis 1.1);
study from being included in quantitative synthesis. assessments included measures from FES-S, mFES, ABC, FES-I, FES,
and single-item instruments.
Effects of interventions
CBT-only interventions showed a low level of heterogeneity (I2 less
See: Summary of findings 1 CBT interventions (CBT with and
than 40%), the CBT with exercise interventions and the pooled
without exercise) compared to control (standard care or sham
treatments) for reducing fear of falling (FoF) in older people living effect sizes of both interventions show a moderate heterogeneity (I2
in the community greater than 40%). Formal tests of subgroup differences according
to whether exercise was included in the intervention indicated
See Summary of findings 1 for the main comparison: CBT no differences between the two intervention types (P = 0.53). We
interventions for reducing fear of falling in community-dwelling conducted all prespecified sensitivity analyses (Analysis 1.1). Whilst
older people. statistical heterogeneity was sometimes reduced, the effect sizes
were similar to our primary analysis, and we did not alter our
Primary outcome interpretation of the effect as a result of sensitivity analysis (see
Table 3).
Fear of falling
We pooled data from 11/12 included studies (all but Tennstedt Subgroup analyses
1998) (2357 participants; 1238 in intervention arm, 1119 in control In formal tests for subgroup interactions, we found no differences
arm) in a meta-analysis for CBT interventions for reducing FoF. in both a priori or post-hoc analysis findings according to the mean
There were clustering issues in three studies (Freiberger 2013; age of participants (note: Huang 2011 was excluded, as they did
Reinsch 1992; Resnick 2008). Freiberger 2013 incorporated an not report mean age of participants) (Analysis 1.2), the type of
analysis design using a three-level linear mixed-effects model. control (Analysis 1.3), if their interventions were based on AMB or
Their reported data adequately adjusted for clustering and were not (Analysis 1.4), or individual or group interventions (Analysis
incorporated directly in the quantitative synthesis of this review. 1.5); the 95% CI in the subgroups clearly overlapped, which was
Reinsch 1992 did not address the cluster design; therefore, we reflected by large P values for the test for subgroup differences.
adjusted their data: for the FoF outcomes of the CBT only group and These results remained true when the outlier, Freiberger 2012, was
CBT with exercise group, we adjusted the denominator values for removed (see Table 4).
participants in the intervention groups from 32 to 28 participants
and from 50 to 43 participants, respectively. We similarly adjusted Publication bias
the control group denominator values from 23 to 20 and then There was no significant publication bias suspected. Visual
divided the control group when comparing with each of the inspection of the funnel plot of the postintervention effects of CBT
interventions group within the same analysis (CBT only and CBT interventions for FoF showed no asymmetry. This was considered
with exercise; 10 participants for each subgroup). Resnick 2008 did valid as there were over 10 studies, and study populations varied
not adjust for clustering, as they considered that the clustering (see sample sizes) (Deeks 2022).
resulted in significant outcome differences. However, for purposes
of this review, we adjusted their sample sizes to account for Sustainability of fear of falling effects up to six months'
the clustering effect. We adjusted the intervention and control postintervention
groups from 64 to 56 participants and from 39 to 34 participants,
Eight of 11 studies included in quantitative synthesis reported
respectively.
sustainability of effects, up to six months' postintervention
Immediate postintervention effects on fear of falling (Arkkukangas 2019; Dorresteijn 2016; Freiberger 2012; Gitlin 2006;
Huang 2011; Parry 2016a; Wetherell 2018; Zijlstra 2009). One study
When pooled using the SMD, we found that CBT with and without had two intervention arms (Huang 2011). When pooled using the
exercise interventions versus control probably reduces FoF (SMD SMD, we found that CBT with and without exercise interventions
−0.23, 95% CI −0.36 to −0.11; I2 = 48%; 11 studies, 2357 participants; versus control may sustain a reduction FoF up to six months'
moderate-certainty evidence; Analysis 1.1). Two studies had a CBT- postintervention (SMD −0.24, 95% CI −0.41 to −0.07; I2 = 63%; 8
only arm and a CBT with exercise arm (Huang 2011; Reinsch studies, 1784 participants; low-certainty evidence; Analysis 2.1). We
1992). We re-expressed the SMD on the FES-I using an SD of 9.41 re-expressed the SMD on the FES-I, using an SD of 9.41 from the
from the baseline measures of Parry 2016a. This corresponds to baseline measures of Parry 2016a. This corresponds to a reduction
a reduction on the FES-I scale of 2.2 (95% CI −3.4 to −1.0). Using on the FES-I scale of 2.3 (95% CI −4.3 to −0.19). Using a rule of
a rule of thumb interpretation, we judged the size of this effect thumb interpretation, we judged the size of this effect to be small.
to be small. We judged this evidence to be moderate certainty, We judged this evidence to be of low certainty, downgrading by
downgrading one level for serious risk of bias across all studies one level owing to serious risk of bias across all studies due to
due to performance and detection bias; and due to the nature performance and detection bias; and due to inconsistency in the
of psychological interventions, studies included unavoidable high CBT with exercise subgroup having substantial heterogeneity.
risk of performance and detection bias.
The sustainability of effects of CBT-only interventions versus
CBT-only interventions probably reduce FoF (SMD −0.31, 95% CI control were assessed using the FES and FES-I. We found that FoF
−0.56 to −0.05; I2 = 25%; 3 studies, 472 participants; Analysis may be reduced (SMD −0.27, 95% CI −0.47 to −0.07; I2 = 0%; 2 studies,
1.1); this included measures from the FES-I, FES, and single-item 404 participants; Analysis 2.1). The sustainability of effects of CBT
instrument. We found a similar result with reduced FoF when CBT with exercise interventions were assessed using the ABC, FES-S,
interventions included an exercise component (SMD −0.22, 95% CI mFES, FES-I, and FES. We found that FoF may be reduced (SMD
Informed decisions.
−0.24, 95% CI −0.46 to −0.02; I2 = 72%; 7 studies, 1380 participants; exercise interventions probably reduces FoF (SMD −0.24, 95% CI
Analysis 2.1). −0.39 to −0.08; I2 = 19%; 4 studies, 871 participants; Analysis 3.1).
There was no heterogeneity with CBT-only interventions (0%), with Formal tests of subgroup differences according to whether
the CBT with exercise interventions alone and the pooled effect exercise was included in the intervention indicated no differences
sizes of both interventions showed moderate heterogeneity (I2 between the two intervention types (P = 0.32). We conducted the
greater than 50%). Formal tests of subgroup differences according prespecified sensitivity analyses on Analysis 3.1. Whilst statistical
to whether exercise was included in the intervention indicated heterogeneity was sometimes reduced, the effect sizes were similar
no differences between the two intervention types (P = 0.84). to our primary analysis, and we did not alter our interpretation of
We conducted the prespecified sensitivity analyses (Analysis 2.1). the effect as a result of sensitivity analysis (see Table 3).
Whilst statistical heterogeneity was sometimes reduced, the effect
sizes were similar to our primary analysis, and we did not alter our Subgroup analyses
interpretation of the effect as a result of sensitivity analysis (see In formal tests for subgroup interactions, we found no differences
Table 3). in both a priori or post-hoc analysis findings according to if their
interventions were based on AMB or not (Analysis 3.2), or individual
Subgroup analyses
or group interventions (Analysis 3.3). The 95% CIs in the subgroups
In formal tests for subgroup interactions, we found no differences clearly overlapped, which was reflected by large P values for the
in a priori or post-hoc analyses findings according to the type of test for subgroup differences. This remained true when the outlier,
control (Analysis 2.2), if their interventions were based on AMB or Freiberger 2012, was removed (see Table 4). Subgroup analysis for
not (Analysis 2.3), or individual or group interventions (Analysis type of control group and mean age could not be conducted as
2.4); the 95% CI in the subgroups clearly overlapped, which was all studies reporting sustainability over six months used control
reflected by large P values for the test for subgroup differences. This groups with usual care, and had a baseline mean age of study
remains true when the outlier, Freiberger 2012, was removed (see participants of 75 years and over.
Table 4). Subgroup analysis could not be performed for mean age
of study participants, as all studies reporting on sustainability over Publication bias
six months had a baseline mean age of 75 years and over. As with the outcomes of immediate postintervention effects and
sustainability of effects up to six months' postintervention, there
Publication bias
was no significant publication bias suspected of the outcomes of
As with the outcomes of immediate postintervention effects, there sustainability of effects more than six months' postintervention.
was no significant publication bias suspected of the outcomes Visual inspection of the funnel plot of the postintervention effects
of sustainability of effects, up to six months' postintervention. of CBT interventions for FoF did not show asymmetry. However, in
Visual inspection of the funnel plot of the postintervention effects containing five studies, this analysis may lack validity (Deeks 2022).
of CBT interventions for FoF showed no asymmetry. However, in
containing nine studies, this analysis may lack validity (Deeks 2022). Secondary outcomes
Sustainability of fear of falling effects more than six months'

Activity avoidance
postintervention Two studies reported on activity avoidance; however, due to
Five of 11 studies included in quantitative synthesis reported missing information in Tennstedt 1998, only Dorresteijn 2016 could
sustainability of effects up to six months' postintervention be included in quantitative synthesis. Tennstedt 1998 reported
(Arkkukangas 2019; Dorresteijn 2016; Freiberger 2012; Parry 2016a; the Sickness Impact Profile (SIP), a 68-item scale measuring the
Zijlstra 2009). When pooled using the SMD, we found that CBT changes in a person's behaviour because of health problems.
with and without exercise interventions versus control probably Dorresteijn 2016 reported on activity avoidance measured using
sustains a reduction in FoF more than six months'' postintervention the FES-IAB. CBT-only interventions may reduce the level of
(SMD −0.28, 95% CI −0.40 to −0.15; I2 = 14%; 5 studies, 1185 activity avoidance (MD −2.57, 95% CI −4.67 to −0.47; 1 study, 312
participants; moderate-certainty evidence; Analysis 3.1). We re- participants; low-certainty evidence; Analysis 4.1). We downgraded
expressed the SMD on the FES-I, using an SD of 9.41 from the evidence one level owing to serious risk of bias due to
the baseline measures of Parry 2016a. This corresponds to a performance and detection bias, and due to imprecision, as there
reduction on the FES-I scale of 2.6 (95% CI −3.8 to −1.8). Using were fewer than 200 participants in each study group (Cochrane
a rule of thumb interpretation, we judged the size of this effect 2022).
to be small. We judged this evidence to be moderate certainty
Occurrence of falls
downgrading one level owing to serious risk of bias across all
studies due to performance and detection bias; due to the nature Eight studies reported the occurrence of falls (Arkkukangas 2019;
of psychological interventions, studies included unavoidable high Dorresteijn 2016; Huang 2011; Parry 2016a; Reinsch 1992; Tennstedt
risk of performance and detection bias. 1998; Wetherell 2018; Zijlstra 2009); however, Parry 2016a, Reinsch
1992, and Tennstedt 1998 did not publish sufficient data to be
The sustainability of effects of CBT-only interventions versus included in the quantitative synthesis. Huang 2011 published
control were assessed using the FES-I. We found that CBT-only outcomes from two intervention arms (CBT only and CBT with
interventions probably reduces FoF (SMD −0.38, 95% CI −0.60 to exercise) and, as such, appeared twice in the analysis. The
−0.15; 1 study, 314 participants; Analysis 3.1). The sustainability outcomes were dichotomised (falls versus no falls) and assessed
of effects of CBT with exercise interventions versus control were using a random-effects model, calculating an RR with 95% CIs. The
assessed used the FES-I, FES-S, and mFES. We found that CBT with CBT-only intervention had an RR of 0.50 (95% CI 0.21 to 1.20; 1 study,
Informed decisions.
90 participants). The CBT with exercise interventions had an RR of functioning) (Resnick 2008). Parry 2016a used three measures of
1.04 (95% CI 0.70 to 1.53; I2 = 82%; 5 studies, 1029 participants). The quality of life; WHOQOL-OLD, the Euro quality of life-5 Dimension
overall pooled RR of CBT with and without exercise interventions (EQ-5D (5L)), and the Short-Form Six-Dimension (SF-6D). The
was 0.96 (95% CI 0.66 to 1.39; I2 = 80; 5 studies (of which Huang 2011 WHOQOL-OLD was given preference over the EQ-OLD, EQ-5D, and
had two intervention arms), 1119 participants; very low-certainty SF-6D due to its specific focus on aged populations (Siette 2021).
evidence; Analysis 4.2). We are uncertain whether CBT with and The SF-12 used by Resnick 2008 consisted of physical well-being
without exercise interventions reduces falls. We downgraded the and mental health well-being mean (SD) scores. The physical well-
evidence one level owing to serious risk of bias across all studies being and mental health well-being mean (SD) subscores were
due to performance and detection bias; one level due to serious combined for data synthesis.
inconsistency owing to heterogeneity existing between studies in
the CBT with exercise groups; and one level for serious imprecision CBT-only interventions had an inconclusive effect size (SMD −0.04,
owing to CI indicating both benefit and harm. 95% CI −0.23 to 0.14; I2 = 0%; 3 studies, 472 participants; Analysis
4.5). CBT with exercise interventions also had an inconclusive effect
The pooled RR is inconclusive, not ruling out either benefit or harm size (SMD −0.47, 95% CI −0.98 to 0.05; I2 = 67%; 3 studies, 229
of the CBT interventions for reducing the risk of falling. participants; Analysis 4.5). Their pooled effect size was inconclusive
(SMD −0.24, 95% CI −0.51 to 0.04; I2 = 58%; 4 studies (of which two
Depression had a CBT-only arm and CBT with exercise arm), 701 participants;
Two studies reported depression using the HADS-D subscore Analysis 4.5).
for depression (Parry 2016a) and GDS (Resnick 2008) (Analysis
We are uncertain whether CBT with and without exercise
4.3). Parry 2016a reported that their CBT-only intervention may
interventions improves QoL. We judged this evidence to be of very
reduce depression (MD −1.26, 95% CI −1.96 to −0.56; 1 study,
low certainty, downgrading one level owing to serious risk of bias
314 participants; Table 5). The mean HADS-D control group score
across all studies due to performance and detection bias; one
was 0.1 (SD 2.65). Resnick 2008 did not adjust for clustering for
level due to serious inconsistency owing to heterogeneity existing
depression outcomes. For the purpose of this review, we adjusted
between studies in the CBT with exercise groups; and one level
their data for clustering, adjusting the intervention and control
for serious imprecision owing to CIs being compatible with either
groups to 56 and 34 from 64 and 39 participants, respectively.
benefit or harm of the intervention.
Resnick 2008 reported that their CBT with exercise intervention
may also reduce depression (MD −0.38, 95% CI −0.80 to 0.04; 1 study, Burden of treatment
90 participants; Table 5). The average GDS control group score was
0.79 (SD 1.1). As there was only one study in each intervention No studies reported data to assess the burden of treatment.
subgroup reporting depression outcomes, we reported these as
separate analyses in Summary of findings 1. When we pooled the DISCUSSION
results from the two studies using an SMD, we found that CBT
with and without exercise may reduce the level of depression (SMD Summary of main results
−0.41, 95% −0.60 to −0.21; 2 studies, 404 participants; low-certainty The included studies assessed the effects of CBT in reducing FoF
evidence; Analysis 4.3). Using a rule of thumb interpretation, we in older people living in the community. This review identified
judged the size of this effect to be small. We downgraded the 12 studies, of which 11 were included for quantitative synthesis,
evidence one level owing to serious risk of bias across both totalling 2383 participants after adjustment for clustering (1250
studies due to performance and detection bias; and one level for in intervention arm, 1133 in control arm instead of 1273 in
serious imprecision owing to having fewer than 200 participants intervention arm and 1146 in control arm), that investigated the
(combined) in the control arm of the included studies. effects of CBT with and without exercise interventions versus
control. A summary of the evidence is presented in Summary of
Anxiety findings 1.
Only one study reported anxiety measured using the HADS
subscore for anxiety (Parry 2016a). The effect size was not The immediate postintervention effect, and sustainability of effect
conclusive (MD 0.06, 95% CI −0.60 to 0.72; 1 study, 344 participants; up to six months and more than six months showed a small
Analysis 4.4). reduction in effect size. The certainty of evidence was moderate
(immediate effect), low (short-term sustainability), and moderate
Adverse effects (long-term sustainability). These results suggest that CBT with and
without exercise interventions probably reduces FoF following the
No studies measured adverse effects associated with their end of treatment and over six months, compared to control. The
interventions. benefits up to six months may be sustained following cessation
of the intervention. Sensitivity analyses show that the conclusions
Quality of life
from the primary analysis remain stable.
Four studies measured QoL using various measures: WHOQOL-
BREF (26-item scale, higher score represents higher quality of life) Immediate postintervention effects and sustainability of effects
(Huang 2011), WHOQOL-Older Adults Module (WHOQOL-OLD, 24- up to six months showed moderate levels of heterogeneity.
item scale, higher score represents higher quality of life) (Parry Considering the variations in intervention designs (CBT only, CBT
2016a), self-rated health questionnaire (1-item scale, rated 1 to 5, with exercise, duration, and group or individual interventions)
lower score represent greater health) (Reinsch 1992), and the 12- and population characteristics (in particular age and proportion
item Short Form Health Survey (SF-12; higher score indicate better of participants falling at baseline), the clinical diversity may be a
significant source of heterogeneity.
Informed decisions.
Heterogeneity could not be explained through subgroup analyses weightings for individuals and populations, considering that the
separating studies based on age group, baseline fall rate, type significance of fear, concern, or worry about falling can differ across
of control group, AMB and non-AMB interventions, individual and different situations (such as bathing, showering, or walking around
group interventions, and duration of intervention through formal the neighbourhood) (Kendrick 2014). Of note, Ellmers 2023, in
tests for subgroup interactions. one study on a special population, where people had cervical
compressive myelopathy, estimated an MCID at 5.5 points using
We conducted secondary analyses for activity avoidance, an anchor-based calculation method and 10 using a distribution-
occurrence of falls, depression, anxiety, adverse effects, and QoL. based method.
Although only one study reported activity avoidance, it found
that CBT-only interventions for FoF may reduce activity avoidance. There was limited reporting of our secondary outcomes,
However, we are uncertain if the occurrence of falls, depression, particularly concerning adverse effects. Occurrence of falls was the
anxiety, or QoL are changed following intervention, due to very low- most reported secondary outcome, in only eight of 11 studies for
certainty evidence. No study reported information about adverse quantitative synthesis, whereas only one study reported on activity
effects (harms). avoidance. Considering that FoF is defined as a "lasting concern
about falling that leads to an individual avoiding activities that he/
Overall completeness and applicability of evidence she remains capable of performing", this relevant measurement
seems to be under-reported.
The studies included in this review are likely most representative
of high-income countries. However, this review is unlikely to be
Quality of the evidence
internationally representative, due to a lack of research conducted
on populations in low- to middle-income countries, despite studies The GRADE approach assessed the certainty of evidence from
showing a high prevalence of FoF in low- to middle-income moderate to very low across the different outcomes, as presented
countries (Birhanie 2021). This is significant, as FoF is higher in Summary of findings 1. Several studies did not publish sufficient
in minority ethnic groups, lower educational groups, and lower data to fully assess their risk of bias, resulting in uncertainty across
household income groups (Kumar 2014). These groups should many domains. Some authors responded to requests for additional
receive particular attention when implementing such treatments information allowing for improving the certainty of the risk of
in clinical practice. The included studies were heterogeneous, bias (Freiberger 2012; Freiberger 2013; Gitlin 2006; Resnick 2008;
showing a variation in study population, such as mean age Tennstedt 1998; Zijlstra 2009).
and baseline fall rates, demonstrating possible variations in
recruitment approaches, potentially reducing the true generality of The body of evidence for all outcomes was downgraded due to
community-dwelling older adults. serious risk of bias. Blinding of participants to their intervention
groups was not possible, due to the nature of the psychological
Tennstedt 1998, which used a CBT with exercise intervention interventions and studies used self-rated questionnaires for
called A Matter of Balance (AMB), was a large study with 434 measuring outcomes, resulting in a high risk of performance and
participants that could not be included in quantitative synthesis detection bias.
due to insufficient data published in their manuscript. The study
published FoF effect size, as measured by the FES, for only the Serious inconsistency additionally lowered the certainty of
intervention group, and not the control group. We were informed evidence in most outcomes. Interventions varied significantly in
by study authors that the data were likely destroyed. This study duration, intensity, and design (e.g. AMB-based, group versus
showed positive results of their intervention. The omission of individual, CBT only versus CBT with exercise). This was
this study likely reduces the certainty of the results presented in demonstrated by the presence of statistical heterogeneity between
this review. This is additionally significant, as three other studies pooled studies. The low level of certainty for FoF sustainability of
included in this review were based on, or incorporated elements of, effects up to six months' postintervention was due to inconsistency
AMB (Dorresteijn 2016; Freiberger 2012; Zijlstra 2009). between the CBT with and without exercise subgroups having
substantial heterogeneity.
Detailed protocols of the different interventions included in this
review were generally not publicly available, and as such limit the No outcomes were downgraded due to indirectness or publication
qualitative analysis of the descriptions of the studies. Therefore, the bias. Most studies included in the review compared their
individual intervention's components were difficult to compare, intervention to a placebo, except for Wetherell 2018, who compared
particularly when all but Parry 2016a were delivered by trained their intervention to a group receiving education. Although no
health professionals who were not registered psychotherapists and studies reported adverse effects, we do not consider their omission
must therefore have followed a treatment protocol. The lack of a failure to report all results, but rather outcomes that are difficult
greater detail of the interventions limits how they can be compared, to measure due to the nature of CBT interventions.
concerning, for example, duration of CBT and exercise components.
Except for postintervention effects of FoF interventions on
The minimal clinically important difference (MCID) has not yet been activity avoidance, which showed low-certainty evidence, all other
established for FoF measures in the populations used in studies secondary outcomes showed very low-certainty evidence. This
included in this review. The MCID is a measure to demonstrate is likely due to the small number of studies and a low number
genuine clinical improvement, rather than statistical improvement of participants included in the analysis investigating secondary
(Bloom 2023). However, this value does have limitations, as it can outcomes.
vary significantly based on how it is calculated (Franceschini 2023).
Establishing an MCID value may not be possible for FoF outcomes
reported in this review, as FoF scale items may necessitate varying
Informed decisions.
Potential biases in the review process it is non-therapeutic, as an active group, it may have the potential to
influence FoF outcomes. For this reason, we conducted a post-hoc
This review was designed to reduce the risk of bias during the sensitivity analysis by removing Wetherell 2018 from the analyses.
review process. Despite a thorough search of literature, we could Despite its removal, there was no change in the results.
not rule out the possibility that we may not have included some
eligible studies, such as unpublished studies or studies published Agreements and disagreements with other studies or
in other languages not covered by the search. By including articles reviews
published only in English and German, there is potential for
language bias. However, interventions for reducing FoF is not For the primary outcome, this review concurs with similar
language specific, as is the case for traditional Chinese medicine. All reviews of CBT interventions for reducing FoF. One meta-analysis
relevant studies are expected to be covered in English and German conducted by Liu 2019 identified CBT-only interventions to reduce
publications. Therefore, we expect that language bias is small (if at FoF. It identified six trials involving 1626 participants. The meta-
all) and would not affect conclusions. analysis also included Huang 2016, investigating CBT interventions
for reducing FoF in nursing home residents, and Liu 2014 who
To reduce the risk of publication bias, we searched several used an intervention known to reduce FoF as the control group
databases for relevant studies for inclusion. We also searched (Tai Chi only versus Tai Chi with a CBT component). They did
reference lists of included studies for additional studies not not include Reinsch 1992. Despite these variations, their results
identified in the original search strategy. However, this did not remained congruent with the results found in this review: FoF
produce any new studies for inclusion. outcomes measured using the FES-I are reduced over all time
points (immediate postintervention, eight weeks, and two months)
To reduce the risk of reporting bias, when there were insufficient for both the Tai Chi-only and Tai Chi with CBT interventions. In
data available in the published manuscripts, we contacted study contrast to Liu 2019, our review reduced the risks of bias by
authors. This allowed outcome data on one occasion to be included including an additional study, and avoiding potential indirectness
in the study (Freiberger 2013). by including Liu 2014 in the pooled estimate.
Although the Cochrane guidelines and methods were strenuously A second meta-analysis was conducted by Chua 2019 of CBT with
followed during the development of the protocol, biases can still and without exercise interventions for reducing FoF. Their meta-
be present, affecting the procedures that are followed throughout analysis identified 15 studies for quantitative synthesis consisting
the review. For example, we adhered to a strict definition of CBT of 3599 older community-dwelling participants aged 60 years and
that may have excluded studies using therapeutic approaches above. They included additional studies that we excluded from this
similar to our definition, but not entirely fulfilling our definition, review, as we did not consider them to be CBT interventions but
such as some forms of motivational interviewing, or self-help CBT education. They also included Liu 2014 in their pooled estimate.
(Lim 2023). Additionally, many studies during the review process In contrast, their meta-analysis did not include Reinsch 1992,
had partial or no descriptors of speaking components of their Resnick 2008, or Wetherell 2018. However, their results remained
intervention, which could not be verified due to the absence of congruent with the results of this study: small effects in favour
study protocols, or intervention manuals. Therefore, it is possible of CBT interventions immediately postintervention (SMD −0.28,
that CBT interventions could have been missed due to a lack of 95% CI −0.35 to −0.21; 3165 participants, favoured intervention),
adequate description in their titles, abstracts, and publications. and sustainability of effects up to six months (SMD –0.32, 95%
CI –0.49 to –0.15; 1360 participants, favoured intervention) and
Deviations from the protocol may represent a source of potential
more than six months (SMD –0.30, 95% CI –0.45 to –0.14; 1403
bias. The review process limited the language of the review to
participants, favoured intervention). By using a stricter definition
studies published in English and German. This may exclude studies
of CBT, our review provides a clearer understanding of the effects
published in other languages, and as such not fully represent
of CBT interventions, as well as providing subgroup analyses that
the entirety of currently available literature. Post-hoc subgroup
Chua 2019 does not.
analyses were added. Post-hoc analyses should be avoided due to
the risk of "data mining" (Deeks 2022). This review, in trying to keep One related Cochrane Review exists for exercise-only interventions
within the objectives of this review, selected the post-hoc criteria for reducing FoF (Kendrick 2014). The population, comparison,
to ensure that no important elements were missed. Additionally, and outcomes were similar to this review. The pooled effect size
we did not report sustainability of effects of secondary outcomes. for exercise interventions was also small. They reported a small
Data for our secondary outcomes were limited by a smaller number effect size for immediate postintervention effects (SMD 0.37, 95%
of studies and participants. Because of the limited data, we judged CI 0.18 to 0.56, favoured intervention). Feng 2022 conducted a
that it was more meaningful to report immediate postintervention review of exercise-only interventions "to evaluate the extent to
effects rather than explore sustainability of effects. We could not which these interventions followed the exercise principles and
rule out the possibility that we introduced reporting biases owing reported exercise parameters, and quantify the effect of these
to this decision. However, we consider the risk for bias minimal. interventions on reducing FOF." The review also found a small-
to-moderate intervention effect in reducing FoF (SMD −0.34, 95%
Wetherell 2018 used an active control group; FoF education. This
CI −0.44 to −0.23, favoured intervention). Caristia 2021 conducted
study was retained in this review as education for FoF was deemed
a review assessing what type of exercise is associated with fall
to be a sham treatment; education, although a part of CBT, does not
risk reduction in healthy adults aged 50 years and older. FoF, a
on its own fulfil the criteria to be considered CBT or a therapeutic
secondary outcome, decreased with endurance exercises (Caristia
from a CBT perspective. This is supported by Rucker 2006, which
2021). We were unable to determine in our review if there were
found no reduction in FoF from FoF education as compared to usual
benefits to CBT interventions with or without exercise as opposed
care. However, although our interpretation of FoF education is that
to exercise-only interventions, and as such, there were insufficient
Informed decisions.
data to assign individual patients to a specific intervention. The AUTHORS' CONCLUSIONS

review investigated CBT interventions versus control, and not CBT
interventions versus exercise interventions. Therefore, we could Implications for practice
not extract comparisons between CBT and exercise interventions.
Cognitive behavioural therapy (CBT) with and without exercise
Lenouvel 2021 suggested that the selection of a CBT intervention
interventions probably reduces fear of falling (FoF) in older
with or without exercise or exercise-only intervention for reducing
people living in the community immediately after the intervention,
FoF could be guided by the patient frailty status; frail patients could
may sustain improvements up to six months after intervention,
benefit most from exercise as compared to non-frail patients, and
and probably sustains improvements beyond six months. The
hence optimise their treatment.
standardised mean differences (SMDs) calculated for immediate
Kruisbrink 2021 conducted a review of the relationship postintervention effects, sustainability up to six months, and
between characteristics and components of FoF interventions sustainability more than six months correspond to a reduction on
and intervention effectiveness, to determine which overarching the Falls Efficacy Scale – International (FES-I) scale of 2.2 (95%
characteristics of interventions and which components of confidence interval (CI) 3.4 to 1.0), 2.3 (95% CI 4.3 to 0.19), and 2.6
interventions are effective in reducing FoF in community-dwelling (95% CI 3.8 to 1.8) points, respectively, on a scale ranging from 16
older people. These reviews demonstrated that FoF interventions (lowest level of FoF) to 64 (highest level of FoF). Subgroup analysis
in general were associated with a small-to-moderate reduction based on an intervention approach (CBT only versus CBT with
in FoF immediately postintervention. Body awareness, holistic exercise) shows similar SMDs, and as such, does not suggest that a
exercises, meditation, and delivery of the intervention in the particular approach is associated with greater improvement of FoF
community setting were more effective at reducing FoF (Kruisbrink outcomes.
2021). Given the aim of our review, we did not study the effects of
One of the main reasons why effect sizes are so small and
characteristics and components of the CBT interventions with and
changes potentially not clinically relevant, is that most studies
without exercise. Additionally, many other factors can influence
in this review have not disentangled between maladaptive
the effect of an intervention on FoF, for example, participant
and non-maladaptive processes. As pointed out in a comment
characteristics such as gender, comorbidity, and previous falls, and
on the recent World Fall Guidelines, concerns that reflect a
other factors related to the intervention, such as the quality of the
realistic and appropriate appraisal of one's risk of falling could
intervention manuals, the quality of the delivery of the intervention
be well treated using structured exercise and balance training
components by the trainer, the quality of the adoption of the
programmes (Montero-Odasso 2022). However, if the concerns
intervention components by the participants, and 'emotional and
are indicative of maladaptive processes, it becomes essential
physical factors' enhancing the setting of the intervention and its
to suggest psychological interventions such as CBT along with
atmosphere.
exercise.
Although no study included in our review reported that there
were adverse effects (harms) due to the intervention, Kempen Implications for research
2011 conducted an observational study of the population from This review established moderate-certainty evidence for CBT
Zijlstra 2009 to examine the long-term mortality effect of a interventions for reducing FoF in older adults living in the
multicomponent cognitive behavioural group intervention to community for immediate effects and sustainability of effects
reduce FoF and activity avoidance in community-dwelling older over six months' postintervention. However, the low certainty of
people (Kempen 2011). They obtained mortality statuses of evidence for sustainability up to six months creates a gap in the
participants for several years following the end of intervention. evidence. Further research may be justified to improve this. This
There were no differences between groups allocated to can be accomplished through improved study design, reducing
intervention and control. However, when only intervention serious concern for imprecision (such as by ensuring sufficiently
participants were included who participated in five or more large study groups), and heterogeneity (such as reducing the risk
sessions, there was a decrease in mortality after three years. for heterogeneity between individual studies, with the use of a
standard measures, such as the FES-I, and consistency in inclusion
Of special note, two more-recent studies investigated online self- criteria, such as age). All studies had a risk of bias due to the nature
guided CBT interventions for FoF, that, due to lack of interactivity of measuring FoF using self-reported qualitative questionnaires.
with a therapist, did not fulfil our inclusion criteria for CBT (Lim Recent advances in gait analysis, in part due to advances in sensor
2023; van Schooten 2021). Lim 2023 is an RCT that uses three technology, have shown that FoF is associated with discrete gait
modules (Managing Fear and Anxiety, Taking Charge of Worry, and characteristics that can be measured for changes over the course
Solving Problems) from the myCompass 2023 online self-help CBT of treatment, therefore reducing the risk of detection bias (Ayoubi
platform. These modules are considered relevant to FoF and are 2014; Lenouvel 2020).
skill building. Participants have six weeks to complete the three
modules. Follow-up measures were at six weeks, six months, and 12 A future direction of research may also consider not only relatively
months. The trial showed high compliance with the modules, and healthy older adults living in the community, but also those
low attrition rates, suggesting that online CBT is a feasible modality. living in assisted living facilities and nursing homes, or special
However, it found no changes in FoF outcomes. van Schooten 2021 populations with different diseases or comorbidities (or both).
is an ongoing RCT. It adds a CBT component to the Standing Tall Considering the significant proportion of the elderly population
exercise intervention, using the myCompass 2023 platform given living in nursing homes or with comorbidities, this would allow
over 12 months. for a better understanding of FoF interventions in a greater
population. Relevant but still unclear aspects include gender-
related differences in FoF with higher prevalence of FoF in women
Informed decisions.
despite comparable prevalence of falls (Pohl 2015), as well as ACKNOWLEDGEMENTS

gender-specific aspects with respect to therapy initiation (Berger
2013) or treatment effects (Lim 2018). Future intervention providers This project was supported by the National Institute for Health
should integrate information about gender-specific factors that Research (NIHR) via Cochrane Infrastructure funding to the
influence openness and acceptance of CBT interventions as well Cochrane Bone, Joint and Muscle Trauma (BJMT) Group. The
as FoF-related aspects to target those who are likely to be most views and opinions expressed herein are those of the review
interested. authors and do not necessarily reflect those of the Systematic
Reviews Programme, NIHR, National Health Service (NHS), or the
We adhere to a strict definition of CBT that is defined primarily Department of Health.
through the element of interactivity, and as such requiring
an in-person presence. Recent trends in artificial intelligence We would like to thank Joanne Elliott and Sharon Lewis for
may soon evolve to provide sufficient interactivity that the in- providing editorial support and guidance in preparing this work.
person component is no longer required to fulfil this criterion of We thank Maria Clark for her assistance in developing the search
interactivity. Future studies could therefore take into consideration strategy and advice on the search methods.
the rapid development of artificial intelligence programming in
psychotherapy. We would also like to thank in particular Dr Sebastian Voigt-Radloff,
who was an author of the protocol but could not continue in the full
There were no differences found with certainty in the subgroup review, for his encouragement throughout the various stages of this
analyses. Future research should consider focusing on stratifying review.
data according to baseline age or limiting their inclusion criteria
to specific age groups of older adults. Additionally, future studies Editorial and peer-reviewer contributions
could investigate intervention characteristics, such as duration. Cochrane BJMT Group supported the review authors in the
Studies are needed that compare the dose-effectivity of short- development of this review.
versus long-term CBT interventions to better demonstrate the time
to benefit effects. The following people conducted the editorial process for this
article.
This review cannot demonstrate preference for FoF between CBT
interventions and exercise interventions. Future meta-analyses • Sign-off Editor (final editorial decision): Rebecca Fortescue, St
could be designed to allow for this comparison. This would better George's, University of London
improve our knowledge of the advantages of different approaches • Managing Editor (selected peer reviewers, provided editorial
to treating FoF. guidance to authors, edited the article): Liz Bickerdike, Cochrane
Central Editorial Service
Reporting of this review's secondary outcomes amongst included
studies was limited. This suggests an insufficiency of knowledge • Editorial Assistant (conducted editorial policy checks, collated
of secondary benefits to reducing FoF, such as fall rate, anxiety, peer-reviewer comments and supported editorial team): Leticia
depression, quality of life, and longevity. Rodrigues, Cochrane Central Editorial Service
• Copy Editor (copy editing and production): Anne Lawson,
Future studies should make careful consideration on terminology. Cochrane Central Production Service
The World Guidelines for Falls Prevention recommends using • Peer-reviewers (provided comments and recommended an
the terminology "concerns about falling" when making enquiries editorial decision): Nuala Livingstone, Cochrane Evidence
(Montero-Odasso 2022). In addition, reporting on adverse effects Production and Methods Directorate (methods), Jo Platt,
should give careful attention to terminology, as there is a lack of Central Editorial Information Specialist (search), Kim Delbaere,
standardisation and usage of adverse effects terminology (Deeks Neuroscience Research Australia, University of New South Wales
2022). Future studies could report on adverse effects of CBT (clinical), PD DR, Ellen Freiberger, Institute for Biomedicine
interventions, particularly considering that CBT has been shown of Aging, FAU Erlangen-Nürnberg, Germany (clinical), Dr Toby
to incur adverse effects (Parry 2016b; Strauss 2021). Furthermore, J Ellmers, Department of Brain Sciences, Imperial College
investigation of the sustainability of negative effects can help clarify London, UK (clinical), and Brian Duncan (consumer).
how the adverse effects evolve following the end of treatment.
Informed decisions.
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CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Informed decisions.
Arkkukangas 2019
Study characteristics
Methods 3-arm RCT
Randomisation performed by an independent statistician who transferred the sequences to consecu-

tively numbered envelopes.
Participants Country: Sweden
n = 175, at-home sessions
Female: 70%
Mean age (years): 83 (SD 4.7)
Inclusion criteria: aged ≥ 75 years, able to walk independently at home, able to understand written and
oral information in the Swedish language
Exclusion criteria: MMSE < 25; ongoing, regular physical therapy treatment due to injury or illness (or
both) or being in terminal care
Interventions CBT with exercise
Arm 1: OEP (n = 61): a series of 17 strength and balance exercises
Arm 2: OEP with MI (n = 58): MI consisted of open-ended questions, affirmations, reflective listening,
and summaries (Miller 1991). The instruction session was calculated to last approximately 1 hour and
consisted of the OEP combined with MI.
The intervention groups had 6 home visits, with the first 5 during the first 3 months. 3 times weekly ex-
ercises at home (1 hour), with walks between sessions (30 minutes). All sessions lasted about 1 hour. 3
telephone calls.
Arm 3: control (n = 56): standard care. No treatment, only surveillance.
Outcomes FES-S; SPPB; handgrip strength; EQ-5D; EQ-5D VAS; Frädlin-Grimby Activity Scale; number of falls
Notes Study start date: November 2012, end date: December 2013.
No conflicts of interest declared.
Source of funding: the National Swedish Board of Health and Welfare, Grants for the County of Väst-
manland. Regional Research Fund for Uppsala and Örebro region, Sweden. Research and Development
Department in the Community of Eskilstuna, Sweden.
Protocol published in 2014. Intermediary results published in 2017.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence genera- Low risk Used computer-generated blocked allocation.

tion (selection bias)
Allocation concealment Low risk Randomisation performed in blocks to minimise the risk of revealing treat-
(selection bias) ment group allocation.
Blinding of participants High risk Blinding of participants not possible due to nature of intervention.
and personnel (perfor-
mance bias)
All outcomes
Informed decisions.
Arkkukangas 2019 (Continued)
Blinding of outcome as- Unclear risk Assessors blinded, but outcomes were self-reported by participants who knew
sessment (detection bias) their group allocation.
All outcomes
Incomplete outcome data Low risk Few participants lost to follow-up.

(attrition bias)
All outcomes
Selective reporting (re- Low risk Protocol published 2014. Study was congruent with protocol.
porting bias)
Other bias Low risk Appeared free of other sources of bias.
Dorresteijn 2016
Methods RCT
Randomisation by external agency blinded to participant characteristics
Participants Country: the Netherlands
n = 389 (intervention: 194, control: 195), at-home sessions
Female: 72.3%
Mean age (years): control: 78.25 (SD 5.3), intervention: 78.35 (SD 5.4)
Inclusion criteria: at least sometimes concerned about falls and associated activity avoidance, and
valued their perceived general health as fair or poor assessed with 1 item of the Medical Outcomes
Study-20 (MOS-20), and signed the informed consent
Exclusion criteria: confined to bed; wheelchair dependent; waiting for nursing home admission; experi-
enced substantial hearing, vision, or cognitive impairments.
Arm 1: home-based format of AMB; 7 individual sessions, including 3 home visits and 4 telephone con-
tacts
Each session had a predefined theme; concerns about falls; thoughts about falling; physical exercise;
asserting oneself; overcoming personal barriers; safe behaviour; managing concerns about falls.
Each session was similarly structured; review of the previous session (except the first session), a discus-
sion of the main theme, the formulation of a personalised action plan related to the discussed theme.
In session 5, participants were guided to safely execute a daily activity they were afraid to perform inde-
pendently (exposure in vivo)
Delivered by community nurses using detailed manuals.
Arm 2: usual care
Outcomes FES-I; FES-IAB; GARS; number of falls (fall diary)
Notes Study start date: March 2009, end date: March 2011 (end of intervention: December 2009, with 15
months of observation).
Informed decisions.
Dorresteijn 2016 (Continued)

Source of funding: ZonMw, the Netherlands Organization for Health Research and Development (grant
120610001) and for author Vlaeyen J, a grant from the Research Foundation, Flanders, Belgium (FWO
Vlaanderen).
Risk of bias
Random sequence genera- Low risk Randomisation conducted by an external agency blinded to participant char-
tion (selection bias) acteristics.
Allocation concealment Low risk Outcome assessors blinded to the allocation.

(selection bias)
mance bias)
All outcomes
All outcomes
Incomplete outcome data Low risk Study authors conducted intention-to-treat analysis and imputed missing da-
(attrition bias) ta.
All outcomes
Selective reporting (re- Low risk Trial registry protocol available.

porting bias)
Freiberger 2012
Methods 4-arm RCT
Randomisation by a third party not involved in the study using a computerised random-number gener-
ator.
Participants Country: Germany
n = 122
Female: 122 (43.6%)
Mean age (years): 76.1 (SD 4.1)
Inclusion criteria: aged ≥ 70 years, having fallen in the past 6 months or FoF, provided signed informed
consent, and completed baseline assessment
Exclusion criteria: unable to ambulate independently, cognitive impairment (DSST score < 25)
Group-based (< 15 participants), 2 × 1-hour sessions per week, over 16 weeks, at an institution (Institute
of Sports Sciences, Erlangen, Germany)
Informed decisions.
Freiberger 2012 (Continued)

Delivered by "fall prevention instructors" (trained by physiotherapist or university-trained sport scien-
tist)
Arm 1: Strength and Balance group (n = 63); progressive exercises for upper and lower body strength
(standing weight-bearing exercises with dumbbells and challenging balance exercises), motor co-
ordination training, ball games, obstacle courses, sensory training (standing and walking with eyes
closed or on unstable surfaces), training in the perception of centre of gravity. Individual progression in
strength training was monitored and adjusted according to the Self-Perceived Exertion Scale.
Arm 2: Fitness group (n = 64); endurance training (walking with change of pace and direction, Nordic
walking) in addition to Strength and Balance group activities. Individual progression was monitored
and adjusted according to the Self-Perceived Exertion Scale.
Arm 3: Multifaceted group (n = 73); AMB component (fall risk education; elements addressed were in
particular attitudes about falls, thoughts and concerns about falling and their effects regarding feelings
and behaviour, and recognising potential environmental fall hazards) and cognitive training (exercises
on concentration, information processing speed, and short-term memory) in addition to the Strength
and Balance group activities.
Arm 4: control group (n = 80)
Outcomes ABC; 2 subscales of the perceived Consequences of Falling scale (Loss of Functional Independence,
Damage to Identity); DSST; Single-item FoF (yes/no); falls; number of days walking per week; TUG;
modified Romberg Test; chair rise test; self-selected normal and fast walking speed over a 10-m dis-
tance
Notes Study start date: 2003, end date: 2006.
Source of funding: The Robert Bosch Foundation and Siemens Health Insurance financially supported
this project.
Protocol published.
Risk of bias
Random sequence genera- Low risk Computer-generated randomisation.

Allocation concealment Low risk Randomisation performed in blocks to minimise the risk of revealing treat-
(selection bias) ment group allocation.
mance bias)
All outcomes
All outcomes
Incomplete outcome data Low risk Missing data balanced between groups by modified intention-to-treat analysis
(attrition bias) using available data.
All outcomes
Selective reporting (re- Low risk Study protocol published.

porting bias)
Informed decisions.
Freiberger 2013
Methods Cluster-RCT
Blockwise randomisation list for both co-ordination centres, by a statistician who was otherwise unin-
volved in the study at the time.
Participants Country: Germany
n = 325 (intervention: 184, control: 141)
Female: intervention: 77.5%, control: 72.4% at baseline
Inclusion criteria: aged ≥ 65 years, reporting ≥ 1 falls in the past year or FoF or physical fall risk obtained
via specific fall risk assessment (or a combination of these), being mobile (able to stand alone and walk
alone or with assistive device)
Exclusion criteria: wheelchair dependent
Arm 1: group intervention with 5–15 participants, 16 supervised sessions, once weekly for 60 minutes.
Group sessions focused on CBT twice in month 2, twice in month 3, and once in month 4, total 5 times.
Starting from week 5, participants added ≥ 1 unsupervised session for total number of session of 28.
Supervised session structure; 5-minute discussion to introduce the topic of the session and address
participants' well-being and questions, followed by a 10-minute warm-up phase, leading to a 30- to 40-
minute conditioning period, followed by a 5- to 10-minute cooling down and closing phase with relax-
ation and discussion between the participants and instructors about the experience. Group sessions fo-
cused on CBT twice in month 2, twice in month 3, and once in month 4, total 5 times
Exercise programme used only bodyweight, no additional equipment
Arm 2: control group: standard care
Delivered by physiotherapist or university-trained sport scientist
Outcomes FES-I; CST; TUG; modified Romberg test
Notes Study start date: 2011 (not specified explicitly), end date: 2012 (study duration 12 months).
No conflicts of interest were declared.
Source of funding: The Bavarian State Ministry of the Environment and Public Health (Gesund. Leben.
Bayern.) (Grant number: LP 00110, Pr Nr 09-10).
Additional study data not available in study manuscript were obtained following contact with author
(Ellen Freiberger)
Protocol published. Intervention developed from Freiberger 2012.
Risk of bias
Informed decisions.
Random sequence genera- Low risk Blockwise randomisation list for both co-ordination centres, by a statistician
tion (selection bias) who was otherwise uninvolved in the study at the time.
Allocation concealment High risk No blinding of staff for participant allocation and group allocation was known
(selection bias) before participants were included.
mance bias)
All outcomes
Blinding of outcome as- High risk No blinding of assessors and outcomes were self-reported by participants who
sessment (detection bias) knew their group allocation.
All outcomes
Incomplete outcome data Low risk Outcome data based on > 80% of intervention group.
(attrition bias)
All outcomes
Selective reporting (re- Low risk Study protocol published in trial registry
porting bias)
Other bias Low risk Additional risk of bias domain for cluster RCTs
• Recruitment: no concerns identified

• Baseline imbalance: no concerns identified
• Loss of clusters: no concerns identified
• Incorrect analysis: clustering was accounted for in the study's analysis
• Comparability with individually randomised trials: no concerns identified
Gitlin 2006
Methods RCT
Randomisation: stratification (white people, non-white people, and living alone or with others), ran-
domised within each of 4 strata using random permuted blocks. The blocking number remained un-
known. Randomisation lists and 4 sets of randomisation were prepared using double, opaque en-
velopes.
Participants Country: USA
Female: intervention: 82.5%, control: 81.1%
Mean age (years): intervention: 79.5 (SD 6.1), control: 78.5 (SD 5.7)
Inclusion criteria: aged ≥ 70 years, cognitively intact (MMSE > 23), English speaking
Exclusion criteria: receiving home care, reported the need for help or difficulties with 2 iADLs or ≥ 1
ADLs, non-community living
Interventions Arm 1: individual, at home; 5 occupational therapy contacts (4 × 90-minute visits and 1 × 20- minute
telephone contact), 1 physical therapy visit, then 3 occupational therapist calls (reinforce the use of in-
Informed decisions.
Gitlin 2006 (Continued)

tervention derived strategies and generalise these strategies to new problem areas) over following 6
months.
Semi-structured clinical interview to identify and prioritise problem areas. Problem-solving to identify
behavioural and environmental contributors to performance difficulties. Control-enhancing strategies
through cognitive (problem-solving, reframing), behavioural (pace self, sit instead of stand to perform
tasks), and environmental modifications.
Delivered by occupational therapists
Arm 2: usual care
Outcomes ADLs; iADLs; mobility/transfer; FES-I + 3-items of ABC (confident walking up/down stairs, bending/pick-
ing up slipper from floor, and getting into/out of car without falling).
Notes Study start date: 2000, end date: 2003.
Source of funding: USA National Institute on Aging Grant R01 AG13687.
Risk of bias
Random sequence genera- Low risk Randomisation conducted by a statistician and generated by a computer, in
tion (selection bias) random permuted blocks that remained unknown to others.
Allocation concealment Low risk Randomisation performed in blocks and stored in double opaque envelopes.
(selection bias)
Blinding of participants High risk No blinding of participants.

mance bias)
All outcomes
All outcomes
(attrition bias)
All outcomes
Selective reporting (re- Unclear risk No protocol for the study available.
porting bias)
Huang 2011
Methods 3-arm RCT
Randomisation used a computer-developed random table to randomly assign participants to 3 inter-

vention groups
Informed decisions.
Huang 2011 (Continued)
Participants n = 186, CBT with exercise intervention arm; 62, CBT only arm; 62, control; 62
Female: CBT with exercise: 64.5%, CBT only: 54.8%, control: 56.4%
Inclusion criteria: aged ≥ 60 years, mentally intact (SPMSQ score > 6 for illiterate individuals, > 7 for
those with 6 years of education, > 8 for those with > 6 years of education), resident in the community,
and able to communicate in Mandarin or Taiwanese
Exclusion criteria: had an artificial leg or leg brace, unstable health problems, terminally ill.
Interventions CBT (FoF management model) with exercise (Tai Chi)
Arms 1 and 2: groups of 8–12 participants, weekly sessions for 8 weeks, 60–90 minutes.
CBT component's main strategy was restructuring misconceptions to promote a view of fall risk and
FoF as controllable. Each session covered the following topics: 1. introduction; 2. associations with falls
or FoF; 3. participant's point of view of FoF (positive and negative aspects about the topic); 4. strate-
gies to manage FoF and family support; 5. implementation in the participants' daily life; and 6. prob-
lem-solving (during a fall learning how to fall, stand up, and call for help).
Tai Chi consisted of 10 positions derived from the Yang style. Participants in groups of 10–16 had
lessons 5 times a week, for 8 weeks. Each session of Tai Chi began with warm-up exercises (10 minutes),
followed by teaching and practicing individual forms of the Tai Chi programme (45 minutes), and ended
with cool-down exercises (5 minutes). Participants in the CBT with Tai Chi intervention needed to com-
plete the Tai Chi at least 3 times a week for 8 weeks, and the CBT intervention all 8 sessions.
Given by geriatric and community health nurses (CBT component) and professional Tai Chi instructors
(exercise component)
Arm 3: usual care
Outcomes FES-I; GFFM; number of falls; Tinetti Mobility Scale; ISSB; WHOQOL-BREF (quality of life)
Notes Study start date: March 2007, end date: December 2007.
Sources of financing: National Science Council, Taiwan (Grant number: NSC97-2314-B-182-031-MY3).
Risk of bias
Random sequence genera- Low risk Participants randomly assigned to a group with a computer-developed ran-
tion (selection bias) dom table.
Allocation concealment Low risk Allocation concealed.

(selection bias)
mance bias)
All outcomes
All outcomes
(attrition bias)
Informed decisions.
Huang 2011 (Continued)

All outcomes
Selective reporting (re- Unclear risk Study protocol not published.

porting bias)
Parry 2016a
Methods RCT
Randomisation: a computer-generated blocked allocation, and stratified by site, patient gender, base-
line score on the numeric rating scale for pain when walking (0 vs 1–10) and whether or not the patient
had been referred for strength and balance training
Participants Country: UK
n = 415, intervention: 210, control: 205
Female: intervention: 75.8% (SD 8.5%), control: 75.3% (SD 8.6%)
Mean age (years): intervention: 69.5, control: 70.7
Inclusion criteria: FES-I score > 23, aged ≥ 60 years, community-dwelling
Exclusion criteria: cognitive impairment (MMSE < 24/30), life expectancy < 1 year or unlikely for any oth-
er reason to be unable to complete 1-year follow-up, requiring psychosocial interventions that are un-
related to FoF, current involvement in other investigational studies or trials, or involvement within 30
days prior to study entry, had taken part in previous phase of the study.
Interventions CBT-only intervention, individual, weekly (45 minutes with 15-minute preparation time) for 8 weeks,
with a 6-month booster session.
Arm 1: standard CBT interventions for identified problems (the 3 P's (predisposing, precipitating, and
perpetuating) model) were described and practised: graded exposure for anxiety; activity monitoring,
graded activity and behavioural activation for pain, fatigue, and low mood; and sleep management for
fatigue. For other recurrent issues, healthcare assistant were taught specific cognitive techniques, such
as identifying thoughts; making explicit the links between thoughts, feelings, and behaviour; thought
diaries; thought challenging; and cost–benefit analysis for catastrophic and otherwise unhelpful cogni-
tions.
Delivered by healthcare assistants
Arm 2: standard care for falls service
Outcomes FES-I; Falls (falls diary); HADS; Numeric Rating Scale for pain when walking; Numeric Rating Scale for
FoF when walking; MMSE; WHOQOL-OLD; EQ-5D (5L); SF-36; 11-item De Jong Gierveld Loneliness Scale;
LSNS-6; Social Participation Questionnaire; SPPB; functional reach; handgrip strength; adverse events
Notes Study start date: 3 July 2012, end date: 31 January 2015.
Sources of funding: NIHR Health Technology Assessment programme
Risk of bias
Informed decisions.
Parry 2016a (Continued)
Random sequence genera- Low risk Computer-developed random table randomised participants.
Allocation concealment Low risk Group allocation concealed from a research assistant who was only responsi-
(selection bias) ble for participant recruitment and group allocation in this study.
mance bias)
All outcomes
Blinding of outcome as- High risk The research team, including those collecting outcome data and the statisti-
sessment (detection bias) cian analysing data, were not blinded, and outcomes were self-reported by
All outcomes participants who knew their group allocation.
Incomplete outcome data High risk Missing data were imputed with intention-to-treat analysis.
(attrition bias)
All outcomes
Selective reporting (re- Low risk Protocol published in manuscript.

porting bias)
Reinsch 1992
Methods 4-arm cluster-RCT
16 senior centres were randomly assigned to 1 of 4 treatment groups (exercise, CBT, CBT with exercise,
discussion control), and all participants at a centre were given the same intervention.
n = 230
Females: number not reported
Inclusion criteria: community-dwelling people aged ≥ 60 years
Exclusion criteria: did not meet inclusion criteria
Interventions Arm 1: CBT; 1 hour, 1 day per week, for 1 year. Each class meeting covered a health and safety curricu-
lum to prevent falls, relaxation training to lower tension and fear, and videogame playing to improve
reaction time. There was a CBT protocol.
Arm 2: CBT with exercise; 1 hour, 3 days per week, for 1 year; 1 class meeting per week followed the CBT
protocol and 2 meetings focused on exercise but also included relaxation training and discussion of
safety topics as they arose.
Arm 3: exercise; Stand-up/Step-up program: requiring a specified number of "stand-ups" from a sit-
ting position and "step-ups" onto a 6-inch-high stepping stool. Warm-up and cool-down consisted of
stretching and movement to music.
Informed decisions.
Reinsch 1992 (Continued)

Arm 4: control; 1 hour, 1 day per week, for 1 year; health and discussion topics not specifically related
to fall prevention but of interest to older people were the focus of the discussion control group meet-
ings.
Outcomes Falls; injury; strength and balance; FoF (single-item measure 1–5); self-rated health
Notes Start date: not specified, end date: 12 months after start.
Source of funding: NIH Grant #AG07350, by the AARP Andrus Foundation, and by the Roosevelt Warm
Springs Foundation.
Risk of bias
Random sequence genera- Unclear risk Randomisation was to centres, rather than individuals, as there was only space
tion (selection bias) for 1 class at each centre. How randomisation was done was not stated.
Allocation concealment Unclear risk Although centres were randomly assigned treatments, it is not clear if inclu-
(selection bias) sion of participants was conducted prior to randomisation procedure.
mance bias)
All outcomes
Blinding of outcome as- High risk Unclear if assessors were blinded and outcomes were self-reported by partici-
sessment (detection bias) pants knowing their group allocation.
All outcomes
Incomplete outcome data High risk Outcome data for FoF (secondary outcome) based on < 80% of intervention
(attrition bias) group.
All outcomes
Selective reporting (re- Unclear risk Protocol not published.

porting bias)
Other bias Unclear risk Additional risk of bias domain for cluster RCTs
• Recruitment: control group had disproportionate ratio of females to males.

• Baseline imbalance: no concerns identified.
• Loss of clusters: no concerns identified.
• Incorrect analysis: study did not adjust for clustering in their analysis.
• Comparability with individually randomised trials: no concerns identified.
Resnick 2008
Methods Cluster-RCT
Sites were randomised by geographic cluster. A coin was tossed to determine allocation
Informed decisions.
Resnick 2008 (Continued)

n = 166
Female: intervention: 79%, control: 83%
Inclusion criteria: aged ≥ 60 years; blood pressure < 200 mmHg systolic and < 100 mmHg diastolic; heart
rate 60–120 beats per minute; and no known recent (within the past 6 months) history of myocardial in-
farction, stroke, or new irregular heartbeat
Exclusion criteria: if they did not obtain a signed note from their primary health care provider acknowl-
edging their participation.
Interventions Arm 1: CBT with exercise (Senior Exercise Self-efficacy Project (SESEP)), 3 sessions/week, 30-minute ef-
ficacy enhancing component, twice-weekly nutrition education, daily home exercises (30 minutes) for
12 weeks
An "efficacy enhancing component" consisted of enactive 1. enactive mastery experiences, involving

successful performance of the activity of interest; 2. verbal persuasion or verbal encouragement by
a credible source, consisting of messages that one is capable of performing the activity; 3. vicarious
experience, which involves seeing individuals similar to oneself perform the activity; 4. reinterpreta-
tion/control of physiological and affective states physiological and affective states such as joy, pain, fa-
tigue, or anxiety associated with or experienced during the activity; and 5. promotion of positive out-
come expectancies, by education about health benefits of exercise. Participants were given a booklet
containing stretching, resistance, and aerobic exercise activities described in a recommended exercise
programme, with images and brief descriptions of how to perform each exercise.
Arm 2: control; nutrition course of equal intensity
Delivered by nutritionists or trained laypeople
Outcomes FoF evaluated by asking the participant to rate his or her FoF on a scale of 0–4; SEE; OEE; YPAS; SF-12;
GDS; Tinetti Scale; chair rise time; pain (0–10 scale)
Notes Start and end dates not specified.
Sources of funding: NYC DOHMH, the New York State Department of Health, and the Robert Wood John-
son Foundation.
Risk of bias
Random sequence genera- Low risk Coin toss used to randomise centres.
Allocation concealment Low risk Coin toss used to determine allocation between the Brooklyn sites and the
(selection bias) South Bronx/Upper Manhattan sites.
mance bias)
All outcomes
All outcomes
Incomplete outcome data High risk Outcome data based on < 80% of intervention group.
(attrition bias)
All outcomes
Informed decisions.
Resnick 2008 (Continued)
Selective reporting (re- Unclear risk Protocol not available.

porting bias)
Other bias Unclear risk Additional risk of bias domain for cluster RCTs

• Incorrect analysis: study did not adjust for clustering in their analysis
Tennstedt 1998
Methods RCT
Unit of randomisation was the housing site. 40 sites recruited for participation and pair-matched on the
basis of number of units and percentage of ethnic minority residents, with 1 site in each pair randomly
assigned to the intervention group and the other site to a placebo attention control group.
n = 434
Female: 89.6%
Age (years): 77.8 (SD 7.71)
Inclusion criteria: aged ≥ 60 years; absence of any major physical or health condition; English speaking;
and self-reported restriction in activity due to fear of falling
Exclusion criteria: inclusion criteria not fulfilled
Interventions Arm 1: group CBT with exercise intervention (AMB), twice-weekly, 2 hours sessions for 4 weeks
The early sessions focused on changing attitudes and self-efficacy prior to attempting changes in actu-
al behaviour. A cognitive restructuring approach instilled adaptive beliefs. Varying activities promot-
ed an adaptive conception of fear of falling with training exercises on how to shift from maladaptive
(self-defeating) to adaptive (motivating) cognitions. Behavioural contracts and goal-setting regarding
desirable changes (e.g. correcting identified home hazards; engaging in physical exercise; resuming a
formerly restricted activity) were used. Strength training exercises (using wide elastic bands for resis-
tance) were included in 6/8 sessions to instruct and encourage participants to continue them indepen-
dently.
Arm 2: control group had a single 2-hour group session consisting of a didactic presentation regarding
incidence and risk factors for falls, a video on home hazards that increase fall risk, and steps that can be
taken to reduce risk, and a group discussion.
Outcomes FES with 2 additional items; carrying bundles from the store and exercising; falls; SIP
Notes Start date: October 1994, end date: July 1996
Sources of funding: National Institute on Aging (Grant No. AG11669).
Contacted authors but study data not retrievable.
Informed decisions.
Tennstedt 1998 (Continued)
Risk of bias
Random sequence genera- Unclear risk Did not explain how randomisation was conducted.
Allocation concealment Unclear risk Due to cluster randomisation, group allocation appeared to be known prior to
(selection bias) recruitment of participants.
mance bias)
All outcomes
All outcomes
(attrition bias)
All outcomes

porting bias)
Other bias High risk Abstract misleading as only compliant group is discussed.
Additional risk of bias domain for cluster RCTs

• Incorrect analysis: study did not adjust for clustering in their analysis. The
study reported only partial data.
Wetherell 2018
Methods RCT
Randomisation was determined using a computer-generated sequence created and held by a col-
league with no other connection to the study; project co-ordinator obtained the assignment after each
participant completed the baseline assessment.
n = 42
Female: intervention: 66.7%, control: 81.0%
Age (years): intervention: 77.3 (SD 7.0), control: 78.5 (SD 7.8)
Inclusion criteria: community-dwelling people aged 65–91 years, FES-I > 27
Informed decisions.
Wetherell 2018 (Continued)

Exclusion criteria: high objective risk of falls or risk of injury: > 2 falls in the past year, requiring the as-
sistance of another person to walk or transfer, orthostasis, history of osteoporotic fracture, body mass
index ≤ 17, cognitive impairment as measured by 10 or more errors on the Blessed Orientation Mem-
ory and Concentration Test, or legally blind; history of schizophrenia or bipolar disorder, alcohol or
drug abuse in the past 6 months, active suicidal ideation, or currently receiving physical therapy or psy-
chotherapy.
Interventions Arm 1: ABLE: individual at-home CBT with exercise intervention; 8 weekly in home sessions lasting ap-
proximately 1 hour each
Combined an empirically supported fall prevention exercise programme, a home safety evaluation,
and exposure-based CBT (manual available upon request from the first author). The CBT component
included psychoeducation about anxiety and the role of avoidance, creation of a fear hierarchy based
on identified triggers and avoidance behaviours, exposure practice, cognitive restructuring, and prob-
lem-solving. The CBT component was primarily delivered in weeks 5–7, with some elements (e.g. psy-
choeducation about fear and avoidance, development of a fear hierarchy, relapse prevention) integrat-
ed into sessions 2, 4, and 8, respectively. Participants were offered the opportunity to invite caregivers
or other support people to attend the sessions.
Exercise component based on the Otago Exercise Program. Participants were additionally instructed to
practice the exercises 3 times a week and walk for up to 30 minutes twice a week. Additionally, partic-
ipants were taught how to get up off the floor after a fall. The home safety assessment was conducted
by a therapist in session 3 based on recommendations for eliminating hazards in the home. During this
session, the therapist helped participants identify and develop an action plan for addressing hazards in
the home (e.g. removing throw rugs, installing grab bars, replacing dim light bulbs with brighter ones).
Arm 2: control; FPE: sessions included education about reducing personal and environmental risk fac-
tors and reducing injury from falls. The education was designed to be an attention placebo condition.
Delivered by physiotherapists receiving weekly supervision from a clinical psychologist. Control ses-
sions were delivered by 1 doctoral-level psychologist and 3 graduate students in clinical psychology
who received weekly supervision.
Outcomes FES-I; Activity Card Sort; CIRS-G; falls (falls diary); anonymous survey completed at home
Notes Start and end dates not specified.
Source of funding: NIMH R34 MH086668.
Details about the control were obtained directly from the lead author, specifying that the education
was designed to be an attention placebo condition.
Risk of bias
Random sequence genera- Low risk Randomisation using a computer-generated sequence.

Allocation concealment Low risk Randomisation was held by a colleague with no other connection to the study.
(selection bias)
Blinding of participants High risk No blinding of participants.

mance bias)
All outcomes
Informed decisions.
Wetherell 2018 (Continued)

All outcomes
(attrition bias)
All outcomes

porting bias)
Other bias Unclear risk Study reported mean and SD score only in figures.
Zijlstra 2009
Methods RCT
Randomisation by an independent researcher blinded to participant characteristics performed block

randomisation (2 communities × 5 cycles) using a computer-generated random allocation.
Participants Country: the Netherlands
Female: intervention: 198 (70.7%), control: 190 (73.1%)
Mean age (years): intervention: 77.8 (SD 4.6), control: 78.0 (SD 5.0)
Inclusion criteria: community dwelling, aged ≥ 70 years, with at least some FoF and at least some activi-
ty avoidance due to FoF
Exclusion criteria: confined to bed, restricted by permanent use of wheelchair, waiting for nursing
home admission, or participating in other intervention
Interventions Arm 1. AMB-NL, a translated and adapted version of AMB; 8 × weekly sessions of 2 hours with booster
session 6 months after the 8th session.
Each session had predefined theme; introduction to programme, exploring thoughts and concerns
about falling, exercise and fall prevention, assertiveness and fall prevention, managing concerns about
falling, recognising 'fall-ty' habits, recognising fall hazards in the home and community, practising no
'fall-ty' habits, booster session
Each session had predefined structure; introduction, participant's point of view, positive and nega-
tive aspects concerning the topic, association with falls or fear of falling, implementation in the partici-
pant's daily life
Delivered by geriatric nurses working for home care agencies
Arm 2: usual care
Outcomes "Are you afraid of falling?"; FES with 4 added items about outdoor activities; PCOF; "Do you avoid cer-
tain activities due to fear of falling" (1–5 scale); FAI; MOS-SF, item 1 (perceived general health); self-rat-
ed life satisfaction (7 point); ADL subscale of GARS; HADS; SSL12-I; feelings of loneliness (6-point Likert
scale); CoF; during the past 4 weeks, how often did you feel lonely (6-point Likert scale); falls (fall calen-
dar and 1-item question, if medical care was provided following the fall)
Notes Overall trial start date: 1 March 2002, overall trial end date: 31 March 2007
Informed decisions.
Zijlstra 2009 (Continued)

Sources of funding: ZonMw – The Netherlands Organization for Health Research and Development
(grant 014-91-052), CAPHRI-School for Public Health and Primary Care, and the Faculty of Health, Medi-
cine and Life Sciences of the Maastricht University.
Protocol published
Risk of bias
Random sequence genera- Low risk An independent researcher blinded to participant characteristics performed
tion (selection bias) block randomisation (2 communities × 5 cycles) using a computer-generated
random allocation.
Allocation concealment Low risk Randomisation was performed directly after baseline measurements were ob-
(selection bias) tained.
Blinding of participants High risk Blinding not possible due to nature of intervention.
mance bias)
All outcomes
All outcomes
Incomplete outcome data Low risk Missing data were imputed.

(attrition bias)
All outcomes
Selective reporting (re- Low risk Protocol published and followed. Of note, although the study started recruit-
porting bias) ment in 2002, the overall trial end date was in 2007. The protocol was pub-
lished in 2005, and is unlikely to introduce a risk of bias as it precedes the end
of the trial.
ABC: Activities-specific Balance Confidence Scale; ABLE: Activity, Balance, Learning, and Exposure intervention; ADL: activities of daily
living; AMB: "A Matter of Balance"; CBT: cognitive behavioural therapy; CIRS-G: Cumulative Illness Rating Scale for Geriatrics; COF:
Consequences of Falling Scale; CST: Chair Stand Test; DSST: Digit Symbol Substitution Test; EQ-5D: EuroQoL-5 Dimension; EQ-5D VAS:
EuroQoL-5 Dimensions Visual Analogue Scale; FAI: Frenchay Activities Index; FES-I: Falls Efficacy Scale – International; FES-IAB: Falls
Efficacy Scale – International Avoidance Behavior; FES-S: Falls Efficacy Scale, Swedish version; FoF: fear of falling; FPE: Fall Prevention
Education; GARS: Gaze Anxiety Rating Scale; GDS: Geriatric Depression Scale; GFFM: Geriatric Fear of Falling Measure; HADS: Hospital
Anxiety and Depression Scale; iADL: instrumental activities of daily living; ISSB: Inventory of Social Supportive Behaviors; LSNS-6: Lubben
Social Network Scale; MI: motivational interviewing; MMSE: Mini-Mental State Examination; MOS-SF: Medical Outcome Study Short Form;
n: number of participants; PCOF: Perceived Control over Falling; OEE: Outcome Expectations for Exercise scale; OEG: Otago Exercise Group;
OEP: Otago Exercise Programme; RCT: randomised controlled trial; SD: standard deviation; SEE: Self-efficacy for Exercise scale; SF-12: 12-
Item Short-Form Health Survey; SF-36: 36-item Short Form Health Survey; SIP: Sickness Impact Profile; SPMSQ: Short Portable Mental
Status Questionnaire; SPPB: Short Physical Performance Battery; SSL12-I - Social Support List of interactions Interaction version; TUG:
Timed Up and Go Test; WHOQOL-BREF: World Health Organization Quality Of Life questionnaire Brief Version; YPAS: Yale Physical Activity
Survey.
Characteristics of excluded studies [ordered by study ID]
Informed decisions.
Study Reason for exclusion
Azizan 2015 Ineligible intervention: the behavioural component did not fulfil the requirements to be considered
CBT.
Banez 2008 Ineligible study design: this was a pre–post intervention study. Furthermore, the interprofessional
team did not consist of elements that would be considered CBT.
Brouwer 2003 Ineligible intervention: education component did not fulfil requirements to be CBT.
Chen 2014 Ineligible study design: a doctoral dissertation that included studies that did not fulfil our inclusion
criteria for study design.
Dattilo 2014 Ineligible intervention: the education used did not fulfil the criteria to be considered CBT.
Duenas 2019 Ineligible control group: included 125 participants randomised to Tai Chi, CBT, and postural control
exercise groups. The control group was an exercise intervention that did not fulfil the criteria for in-
clusion in our review.
Gill 2020 Ineligible intervention: the multifactorial intervention consisted of assessment, recommendations,
motivational interviewing, developing individualised care plans, and implementing the fall care
plans. The motivational interviewing component did not fulfil the requirements to be considered
CBT.
Headley 2014 Ineligible intervention: the N'Balance programme is an exercise intervention, and does not have a
component that would fulfil the criteria for CBT interventions.
IRCT20211201053248N1 Ineligible control group: control group consisted of an exercise intervention; "conventional gait re-
habilitation."
Johansson 2018 Ineligible intervention: intervention programme used a small-group learning environment and
peer learning, with an occupational science focus. It did not fulfil the criteria of CBT.
Kwon 2011 Ineligible intervention: study investigated an exercise intervention.
Lee 2013 Ineligible intervention: intervention group received a risk-based multifactorial fall prevention pro-
gramme including exercise intervention, health education, and home hazards evaluation/modifica-
tion, along with medication review and referral to an ophthalmologist or other specialists.
Lim 2023 Ineligible intervention: online self-guided intervention that did not fulfil the studies as the therapy
was not provided by a person, and as such lacked the interactive nature required for CBT
Lin 2007 Ineligible intervention: this 3-armed study had an exercise intervention, home safety assessment
group, and educational group. There was no CBT component.
Liu 2014 Ineligible control: study compared a CBT group with Tai Chi to a Tai Chi-only group. As the control
group received exercise, it did not fulfil the eligibility criteria for this review.
NCT01268657 Ineligible study design: study delivered CBT intervention. However, it had only 1 arm, and was not a
randomised controlled trial.
NCT02727374 Ineligible control group: study investigated a physiotherapy intervention with CBT intervention.
The control group was a physiotherapy intervention.
NCT03211429 Ineligible control group: 3-armed randomised controlled group, based in Manizales (Colombia),
that investigated a CBT intervention for reducing fear of falling, with Tai Chi, and Postural Control
exercises, and did not fulfil the inclusion criteria of this review.
Informed decisions.
Study Reason for exclusion
Sartor-Glittenberg 2018 Ineligible study design: quasi-experimental, 1-group, pretest–post-test study design investigated
the avoidance outcomes from the A Matter of Balance intervention.
Suttanon 2018 Ineligible intervention: exercise intervention based on the Otago programme. No CBT component.
Thiamwong 2019 Ineligible study design: the Physio-fEedback Exercise pRogram (PEER) intervention consists of visu-
al physio-feedback on balance, cognitive reframing, and peer coaching. However, the study did not
have a control group, and did not fulfil the requirements for inclusion in this review.
van Schooten 2021 Ineligible intervention: the behavioural component did not fulfil the requirements to be considered
CBT – the online component lacked the interactivity of this review's definition of CBT.
Walters 2018 Mismatch with study design: a quantitative descriptive study of an "A Matter of Balance" interven-
tion that had been in place at the senior centre, as part of its regular programming.
Wolfe 2018 Mismatch with study design: study evaluated the change in fear of falling in older adults enrolled in
either Chinese- or Spanish-speaking "Matter of Balance" programmes. There was no non-interven-
tional control arm.
CBT: cognitive behavioural therapy.
Characteristics of ongoing studies [ordered by study ID]
ACTRN12621000440820
Study name Own Your Balance Study: effect of a self-managed online cognitive behavioural therapy program in
older people with concerns about falling
Methods 3-arm RCT
Participants Inclusion criteria: aged ≥ 65 years, concerned about falls or have low balance confidence (or both),
living in the community, English speaking, independent in activities of daily living, able to walk
household distances with or without the use of a walking aid, willing to give informed consent and
comply with the study protocol
Exclusion criteria: cognitive impairment, severe depression or suicidal thoughts, acute psychiatric
condition with psychosis, any medical condition that precludes exercise participation, progressive
neurological conditions (such as Parkinson's disease, multiple sclerosis, Alzheimer's disease), cur-
rently participating in a fall prevention programme
Interventions 2 intervention groups (Own Your Balance Program and Own Your Balance Program plus the Stand-
ingTall graded activity program) delivered via tablet or computer in people's homes with limited
therapist input over 8 weeks. After 8 weeks, both groups will receive individual guidance by tele-
phone, using motivational interviewing techniques, to use the Active and Healthy website to con-
tinue with an exercise programme (≥ 2 hours of exercise each week) for the next 10 months. A fol-
low-up call will be performed at 12 weeks to see if the participants in both intervention groups
have started with their exercise programme.
Outcomes n = 189
Primary outcome: IconFES
Secondary outcomes: IconSAFE; Attitudes to Falls-Related Interventions Scale; DASS-21, depres-

sion, anxiety and stress subscale; Health services used (monthly health services access question-
naire); PGCI; EQ-5D; PACES; ABC; IconFES; FHLS; IPEQ; rate of falls (self-reported); MOS-SS; System
Usability Scale; overall movement intensity (McRoberts MoveMonitor activity monitor); COMPAS-W
Informed decisions.
ACTRN12621000440820 (Continued)
scale; adherence to exercise programmes (self-reported); adherence to the intervention; ESES; ha-
bitual daily activity (McRoberts MoveMonitor activity monitor)
Starting date 7 June 2021
Contact information Professor Kim Delbaere; Neuroscience Research Australia Margarete Ainsworth Building Barker
Street Randwick Sydney NSW 2031 Australia; +61 2 93991066; k.delbaere@neura.edu.au
Notes Completion of data collection expected by July 2023.
NCT05192408
Study name Multi-component Intervention for reducing fear of falling in community-dwelling older adults
Methods RCT
Participants n = 420
Inclusion criteria: adults aged ≥ 65 years; followed up at National Healthcare Group Polyclinics for
any chronic condition; able to communicate in English, Mandarin, and Malay; and reports fear of
falling as screened by single question.
Exclusion criteria: unable to agree to participation, unable or unsafe to participate in any exercise
as determined by clinician (e.g. terminal illness, uncontrolled hypertension, immobility, unable to
participate in telephone sessions e.g. due to hearing impairment), and known psychiatric condition
on treatment
Interventions Intervention (individual): 4 sessions face-to-face or via videoconferencing. CBT component com-
prises behavioural activation, cognitive restructuring, promotion of safety, relaxation techniques,
and motivational interviewing for goal setting. Exercise component comprises patient education
materials and videos tailored to frailty level and readiness to progress, with balance and strength
components.
Control: patient education materials on: exercise in older adults (Stay Active, Stay Strong and Stay
Steady), falls prevention, and fear of falling.
Outcomes Primary outcome: fear of falling measured using short FES-I
Secondary outcome: number of falls, physical activity measured using IPEQ-WA
Starting date 3 January 2022
Contact information Jacqueline G De Roza, National Healthcare Group Polyclinics. Singapore, Singapore, 380130.
+6594500212, Jacqueline_G_De_ROZA@nhgp.com.sg
Notes Expected to be completed May 2023
Taylor 2021
Study name Motivational interviewing to increase walking in community-dwelling older adults after hip fracture
Methods RCT
Participants n = 270
Informed decisions.
Taylor 2021 (Continued)

Inclusion criteria: had a hip fracture, live at home independently, aged ≥ 65 years, have been dis-
charged from hospital within the last 6 months, able to walk independently with or without an as-
sistive device, can communicate with conversational English, insufficiently active (defined as ob-
taining < 150 minutes of moderate-intensity activity per week)
Exclusion criteria: severe depression or anxiety, score > 2 errors on the 10-item Short Portable Men-
tal Status Questionnaire indicative of impaired intellectual functioning, medically unstable to walk,
unable to converse by telephone, live in residential care
Interventions Intervention: telephone-based motivational interviewing to collaboratively work with participants

to assist them to increase their motivation to walk
Control: standard care
Outcomes Primary outcome: daily time spent walking (accelerometer-based activity monitor (activPAL))
Secondary outcomes: 22-item Ambulatory Self-Confidence Questionnaire; DASS-21; feasibility, ad-

vantages and disadvantages of the intervention (inductive thematic analysis of therapists); percep-
tions about receiving the motivational interviewing (inductive thematic analysis of participants);
injuries as a result of a fall (self-reported); daily steps (accelerometer-based activity monitor (ac-
tivPAL)); participant-report of whether they walk outdoors alone or with company, and to report
the frequency of outdoor walks (self-reported); falls (self-reported); daily time spent in moder-
ate-to-vigorous activity (activPAL); cost-effectiveness from a healthcare system perspective; hos-
pital readmissions; daily time sitting or lying (activPAL); nutritional status (Malnutrition Screen-
ing Tool); bodyweight; well-being and capability (ICECAP-O); medical services and pharmaceutical
use (Medicare Australia records); FAI; exploration of experiences of rehabilitation after hip fracture,
and recovery of mobility for a purposive sample of participants in both groups (inductive themat-
ic analysis of participants); AQoL; healthcare utilisation and cost (patient health service utilisation
questionnaire developed for the trial); m-FES
Starting date 29 September 2019
Contact information Professor Nicholas Taylor; Allied Health Clinical Research Office (Eastern Health / La Trobe Univer-
sity) level 2/5 Arnold Street Box Hill VIC 3128 Australia; +61 3 90918874; n.taylor@latrobe.edu.au
Notes Recruitment phase completed. Expected results in 2023.
ABC: Activities-specific Balance Confidence scale; AQoL: Assessment of Quality of Life Instrument; DASS-21: 21-item Depression, Anxiety
and Stress Scale; EQ-5D: EuroQoL-5 Dimension; ESES: Exercise Self Efficacy Scale; FAI: Frenchay Activities Index; FHLS: Fall-Related Health
Literacy; ICECAP-O: ICEpop CAPability measure for Older people; IconFES: Iconographical Falls Efficacy Scale; IconSAFE: Iconographical
Survey of Activities and Fear of Falling in the Elderly; IPEQ: Incidental and PlannEd activity Questionnaire; IPEQ-WA: Incidental and Planned
Exercise Questionnaire for the Usual Week; PGCI: Patient Global Impression of Change Scale; m-FES: modified Falls Efficacy Scale; MOS-
SS: Medical Outcomes Study Social Support Survey; n: number of participants; PACES: Physical Activity Enjoyment Scale; RCT: randomised
controlled trial.
DATA AND ANALYSES
Comparison 1. Fear of falling: immediate postintervention
Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants
1.1 Fear of falling: subgrouped 11 2357 Std. Mean Difference (IV, Random, -0.23 [-0.36, -0.11]
according to intervention ap- 95% CI)
proach
Informed decisions.
pants
1.1.1 CBT only 3 472 Std. Mean Difference (IV, Random, -0.31 [-0.56, -0.05]
95% CI)
1.1.2 CBT with exercise inter- 10 1885 Std. Mean Difference (IV, Random, -0.22 [-0.36, -0.07]
ventions 95% CI)
according to mean age 95% CI)
1.2.1 < 75 years 1 90 Std. Mean Difference (IV, Random, -0.11 [-0.54, 0.32]
95% CI)
1.2.2 ≥ 75 years 9 2091 Std. Mean Difference (IV, Random, -0.23 [-0.38, -0.09]
95% CI)
according to control 95% CI)
1.3.1 Usual care 8 2136 Std. Mean Difference (IV, Random, -0.25 [-0.40, -0.10]
95% CI)
1.3.2 Placebo 3 221 Std. Mean Difference (IV, Random, -0.13 [-0.42, 0.16]
95% CI)
according to "A Matter of Bal- 95% CI)
ance" (AMB) versus non-AMB
based interventions
1.4.1 Non AMB-based interven- 8 1445 Std. Mean Difference (IV, Random, -0.30 [-0.41, -0.19]
tions 95% CI)
1.4.2 AMB-based interventions 3 912 Std. Mean Difference (IV, Random, -0.11 [-0.48, 0.25]
95% CI)
according to group versus indi- 95% CI)
vidual interventions
1.5.1 Individual intervention 5 1103 Std. Mean Difference (IV, Random, -0.30 [-0.43, -0.18]
95% CI)
1.5.2 Group intervention 6 1254 Std. Mean Difference (IV, Random, -0.18 [-0.39, 0.03]
95% CI)
Informed decisions.
Analysis 1.1. Comparison 1: Fear of falling: immediate postintervention,

Outcome 1: Fear of falling: subgrouped according to intervention approach
Intervention Control Std. Mean Difference Std. Mean Difference Risk of Bias
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Random, 95% CI IV, Random, 95% CI A B C D E F G
1.1.1 CBT only

Huang 2011 -90.13 16.85 60 -88.69 20.13 30 5.7% -0.08 [-0.52 , 0.36] + + − ? + ? +
Parry 2016a -4.76 7.2637 164 -1.37 7.9548 180 12.0% -0.44 [-0.66 , -0.23] + + − − − + +
Reinsch 1992 1.6 0.9 28 1.7 1.3 10 2.6% -0.10 [-0.82 , 0.63] ? ? − − − ? ?
Subtotal (95% CI) 252 220 20.3% -0.31 [-0.56 , -0.05]
Heterogeneity: Tau² = 0.02; Chi² = 2.66, df = 2 (P = 0.26); I² = 25%
Test for overall effect: Z = 2.38 (P = 0.02)
1.1.2 CBT with exercise interventions

Arkkukangas 2019 -109.5 18.5 52 -106.2 20.6 55 6.9% -0.17 [-0.55 , 0.21] + + − ? + + +
Dorresteijn 2016 31.37 10.4 141 35.3 10.4 171 11.6% -0.38 [-0.60 , -0.15] + + − ? + + +
Freiberger 2012 -142.7 24.5 65 -150.3 12.4 64 7.6% 0.39 [0.04 , 0.74] + + − ? + + +
Freiberger 2013 23.4 7.5 168 27.4 10.7 129 11.3% -0.44 [-0.67 , -0.21] + − − − + + +
Gitlin 2006 -7.79 1.83 154 -7.45 2.13 146 11.5% -0.17 [-0.40 , 0.06] + + − ? + ? +
Huang 2011 -96.71 14.95 56 -88.69 20.13 30 5.5% -0.47 [-0.92 , -0.02] + + − ? + ? +
Reinsch 1992 1.4 0.8 43 1.7 1.3 10 2.8% -0.33 [-1.02 , 0.37] ? ? − − − ? ?
Resnick 2008 1.6 1.8 56 1.8 1.8 34 5.9% -0.11 [-0.54 , 0.32] + + − ? − ? ?
Wetherell 2018 28.7 116.3826 19 35.35 153.5163 21 3.3% -0.05 [-0.67 , 0.57] + + − ? + ? ?
Zijlstra 2009 25.5 9.7 232 28.2 10.8 239 13.3% -0.26 [-0.44 , -0.08] + + − ? + + +
Subtotal (95% CI) 986 899 79.7% -0.22 [-0.36 , -0.07]
Total (95% CI) 1238 1119 100.0% -0.23 [-0.36 , -0.11]

Test for overall effect: Z = 3.65 (P = 0.0003) -2 -1 0 1 2
Test for subgroup differences: Chi² = 0.39, df = 1 (P = 0.53), I² = 0% Favours Intervention Favours Control
Risk of bias legend

(A) Random sequence generation (selection bias)
(B) Allocation concealment (selection bias)
(C) Blinding of participants and personnel (performance bias)
(D) Blinding of outcome assessment (detection bias)
(E) Incomplete outcome data (attrition bias)
(F) Selective reporting (reporting bias)
(G) Other bias
Informed decisions.

Outcome 2: Fear of falling: subgrouped according to mean age
1.2.1 < 75 years

Resnick 2008 1.6 1.8 56 1.8 1.8 34 6.8% -0.11 [-0.54 , 0.32] + + − ? − ? ?
Subtotal (95% CI) 56 34 6.8% -0.11 [-0.54 , 0.32]
Heterogeneity: Not applicable
1.2.2 ≥ 75 years
Arkkukangas 2019 -109.5 18.5 52 -106.2 20.6 55 7.9% -0.17 [-0.55 , 0.21] + + − ? + + +
Dorresteijn 2016 31.37 10.4 141 35.3 10.4 171 12.9% -0.38 [-0.60 , -0.15] + + − ? + + +
Freiberger 2012 -142.7 24.5 65 -150.3 12.4 64 8.7% 0.39 [0.04 , 0.74] + + − ? + + +
Freiberger 2013 23.4 7.5 168 27.4 10.7 129 12.6% -0.44 [-0.67 , -0.21] + − − − + + +
Gitlin 2006 -7.79 1.83 154 -7.45 2.13 146 12.8% -0.17 [-0.40 , 0.06] + + − ? + ? +
Parry 2016a -4.76 7.2637 164 -1.37 7.9548 180 13.3% -0.44 [-0.66 , -0.23] + + − − − + +
Reinsch 1992 (1) 1.6 0.9 28 1.7 1.3 10 3.1% -0.10 [-0.82 , 0.63] ? ? − − − ? ?
Reinsch 1992 (2) 1.4 0.8 43 1.7 1.3 10 3.3% -0.33 [-1.02 , 0.37] ? ? − − − ? ?
Wetherell 2018 28.7 116.3826 19 35.35 153.5163 21 3.9% -0.05 [-0.67 , 0.57] + + − ? + ? ?
Zijlstra 2009 25.5 9.7 232 28.2 10.8 239 14.6% -0.26 [-0.44 , -0.08] + + − ? + + +
Subtotal (95% CI) 1066 1025 93.2% -0.23 [-0.38 , -0.09]
Total (95% CI) 1122 1059 100.0% -0.23 [-0.36 , -0.09]

Footnotes
(1) CBT only group
(2) CBT with exercise group
Risk of bias legend

(G) Other bias
Informed decisions.

Outcome 3: Fear of falling: subgrouped according to control
1.3.1 Usual care

Arkkukangas 2019 -109.5 18.5 52 -106.2 20.6 55 6.9% -0.17 [-0.55 , 0.21] + + − ? + + +
Dorresteijn 2016 31.37 10.4 141 35.3 10.4 171 11.6% -0.38 [-0.60 , -0.15] + + − ? + + +
Freiberger 2012 -142.7 24.5 65 -150.3 12.4 64 7.6% 0.39 [0.04 , 0.74] + + − ? + + +
Freiberger 2013 23.4 7.5 168 27.4 10.7 129 11.3% -0.44 [-0.67 , -0.21] + − − − + + +
Gitlin 2006 -7.79 1.83 154 -7.45 2.13 146 11.5% -0.17 [-0.40 , 0.06] + + − ? + ? +
Huang 2011 (1) -90.13 16.85 60 -88.69 20.13 30 5.7% -0.08 [-0.52 , 0.36] + + − ? + ? +
Huang 2011 (2) -96.71 14.95 56 -88.69 20.13 30 5.5% -0.47 [-0.92 , -0.02] + + − ? + ? +
Parry 2016a -4.76 7.2637 164 -1.37 7.9548 180 12.0% -0.44 [-0.66 , -0.23] + + − − − + +
Zijlstra 2009 25.5 9.7 232 28.2 10.8 239 13.3% -0.26 [-0.44 , -0.08] + + − ? + + +
Subtotal (95% CI) 1092 1044 85.4% -0.25 [-0.40 , -0.10]
1.3.2 Placebo
Reinsch 1992 (1) 1.6 0.9 28 1.7 1.3 10 2.6% -0.10 [-0.82 , 0.63] ? ? − − − ? ?
Reinsch 1992 (2) 1.4 0.8 43 1.7 1.3 10 2.8% -0.33 [-1.02 , 0.37] ? ? − − − ? ?
Resnick 2008 1.6 1.8 56 1.8 1.8 34 5.9% -0.11 [-0.54 , 0.32] + + − ? − ? ?
Wetherell 2018 28.7 116.3826 19 35.35 153.5163 21 3.3% -0.05 [-0.67 , 0.57] + + − ? + ? ?
Subtotal (95% CI) 146 75 14.6% -0.13 [-0.42 , 0.16]
Total (95% CI) 1238 1119 100.0% -0.23 [-0.36 , -0.11]

Footnotes
(1) CBT only
(2) CBT with exercise
Risk of bias legend

(G) Other bias
Informed decisions.
Analysis 1.4. Comparison 1: Fear of falling: immediate postintervention, Outcome 4: Fear of

falling: subgrouped according to "A Matter of Balance" (AMB) versus non-AMB based interventions
Intervention Control Std. Mean Difference Std. Mean Difference

Study or Subgroup Mean SD Total Mean SD Total Weight IV, Random, 95% CI IV, Random, 95% CI
1.4.1 Non AMB-based interventions

Arkkukangas 2019 -109.5 18.5 52 -106.2 20.6 55 6.9% -0.17 [-0.55 , 0.21]
Freiberger 2013 23.4 7.5 168 27.4 10.7 129 11.3% -0.44 [-0.67 , -0.21]
Gitlin 2006 -7.79 1.83 154 -7.45 2.13 146 11.5% -0.17 [-0.40 , 0.06]
Huang 2011 (1) -90.13 16.85 60 -88.69 20.13 30 5.7% -0.08 [-0.52 , 0.36]
Huang 2011 (2) -96.71 14.95 56 -88.69 20.13 30 5.5% -0.47 [-0.92 , -0.02]
Parry 2016a -4.76 7.2637 164 -1.37 7.9548 180 12.0% -0.44 [-0.66 , -0.23]
Reinsch 1992 (2) 1.4 0.8 43 1.7 1.3 10 2.8% -0.33 [-1.02 , 0.37]
Reinsch 1992 (1) 1.6 0.9 28 1.7 1.3 10 2.6% -0.10 [-0.82 , 0.63]
Resnick 2008 1.6 1.8 56 1.8 1.8 34 5.9% -0.11 [-0.54 , 0.32]
Wetherell 2018 28.7 116.3826 19 35.35 153.5163 21 3.3% -0.05 [-0.67 , 0.57]
Subtotal (95% CI) 800 645 67.5% -0.30 [-0.41 , -0.19]
Test for overall effect: Z = 5.54 (P < 0.00001)
1.4.2 AMB-based interventions

Dorresteijn 2016 31.37 10.4 141 35.3 10.4 171 11.6% -0.38 [-0.60 , -0.15]
Freiberger 2012 -142.7 24.5 65 -150.3 12.4 64 7.6% 0.39 [0.04 , 0.74]
Zijlstra 2009 25.5 9.7 232 28.2 10.8 239 13.3% -0.26 [-0.44 , -0.08]
Subtotal (95% CI) 438 474 32.5% -0.11 [-0.48 , 0.25]
Total (95% CI) 1238 1119 100.0% -0.23 [-0.36 , -0.11]

Test for subgroup differences: Chi² = 0.93, df = 1 (P = 0.33), I² = 0% Favours intervention Favours control
Footnotes
(1) CBT only
Informed decisions.
Analysis 1.5. Comparison 1: Fear of falling: immediate postintervention, Outcome

5: Fear of falling: subgrouped according to group versus individual interventions
1.5.1 Individual intervention

Arkkukangas 2019 -109.5 18.5 52 -106.2 20.6 55 6.9% -0.17 [-0.55 , 0.21] + + − ? + + +
Dorresteijn 2016 31.37 10.4 141 35.3 10.4 171 11.6% -0.38 [-0.60 , -0.15] + + − ? + + +
Gitlin 2006 -7.79 1.83 154 -7.45 2.13 146 11.5% -0.17 [-0.40 , 0.06] + + − ? + ? +
Parry 2016a -4.76 7.2637 164 -1.37 7.9548 180 12.0% -0.44 [-0.66 , -0.23] + + − − − + +
Wetherell 2018 28.7 116.3826 19 35.35 153.5163 21 3.3% -0.05 [-0.67 , 0.57] + + − ? + ? ?
Subtotal (95% CI) 530 573 45.3% -0.30 [-0.43 , -0.18]
1.5.2 Group intervention

Freiberger 2012 -142.7 24.5 65 -150.3 12.4 64 7.6% 0.39 [0.04 , 0.74] + + − ? + + +
Freiberger 2013 23.4 7.5 168 27.4 10.7 129 11.3% -0.44 [-0.67 , -0.21] + − − − + + +
Huang 2011 (1) -96.71 14.95 56 -88.69 20.13 30 5.5% -0.47 [-0.92 , -0.02] + + − ? + ? +
Huang 2011 (2) -90.13 16.85 60 -88.69 20.13 30 5.7% -0.08 [-0.52 , 0.36] + + − ? + ? +
Reinsch 1992 (2) 1.6 0.9 28 1.7 1.3 10 2.6% -0.10 [-0.82 , 0.63] ? ? − − − ? ?
Reinsch 1992 (1) 1.4 0.8 43 1.7 1.3 10 2.8% -0.33 [-1.02 , 0.37] ? ? − − − ? ?
Resnick 2008 1.6 1.8 56 1.8 1.8 34 5.9% -0.11 [-0.54 , 0.32] + + − ? − ? ?
Zijlstra 2009 25.5 9.7 232 28.2 10.8 239 13.3% -0.26 [-0.44 , -0.08] + + − ? + + +
Subtotal (95% CI) 708 546 54.7% -0.18 [-0.39 , 0.03]
Total (95% CI) 1238 1119 100.0% -0.23 [-0.36 , -0.11]

Footnotes
(2) CBT only
Risk of bias legend

(G) Other bias
Comparison 2. Fear of falling: sustainability of effects, up to 6 months' postintervention
pants
according to intervention ap- 95% CI)
proach
95% CI)
2.1.2 CBT with exercise inter- 7 1380 Std. Mean Difference (IV, Random, -0.24 [-0.46, -0.02]
ventions 95% CI)
according to control 95% CI)
2.2.1 Usual care 7 1744 Std. Mean Difference (IV, Random, -0.23 [-0.40, -0.05]
95% CI)
Informed decisions.
pants
2.2.2 Placebo 1 40 Std. Mean Difference (IV, Random, -0.55 [-1.18, 0.09]
95% CI)
according to AMB versus non- 95% CI)
AMB based interventions
2.3.1 Non AMB-based interven- 5 916 Std. Mean Difference (IV, Random, -0.26 [-0.46, -0.07]
tions 95% CI)
2.3.2 AMB-based interventions 3 868 Std. Mean Difference (IV, Random, -0.19 [-0.54, 0.17]
95% CI)
according to group versus indi- 95% CI)
vidual interventions
2.4.1 Individual intervention 5 1052 Std. Mean Difference (IV, Random, -0.25 [-0.39, -0.10]
95% CI)
2.4.2 Group intervention 3 732 Std. Mean Difference (IV, Random, -0.25 [-0.64, 0.15]
95% CI)
Analysis 2.1. Comparison 2: Fear of falling: sustainability of effects, up to 6 months'

postintervention, Outcome 1: Fear of falling: subgrouped according to intervention approach
2.1.1 CBT only

Huang 2011 -90.88 15.72 60 -88.4 18.71 30 8.4% -0.15 [-0.59 , 0.29] + + − ? + ? +
Parry 2016a -5.56 8.3335 151 -2.83 9.504 163 14.5% -0.30 [-0.53 , -0.08] + + − − − + +
Subtotal (95% CI) 211 193 22.9% -0.27 [-0.47 , -0.07]
2.1.2 CBT with exercise interventions

Arkkukangas 2019 -96 25 42 -99 26 44 8.7% 0.12 [-0.31 , 0.54] + + − ? + + +
Dorresteijn 2016 31.98 10.9 141 35.86 11.1 171 14.5% -0.35 [-0.58 , -0.13] + + − ? + + +
Freiberger 2012 -141.3 22.8 71 -146.9 15.5 63 10.8% 0.28 [-0.06 , 0.62] + + − ? + + +
Gitlin 2006 -7.79 1.83 154 -7.45 2.13 146 14.4% -0.17 [-0.40 , 0.06] + + − ? + ? +
Huang 2011 -99.14 11.66 56 -88.4 18.71 30 8.0% -0.73 [-1.19 , -0.28] + + − ? + ? +
Wetherell 2018 31.35 4.7719 19 34.1 5.0528 21 5.2% -0.55 [-1.18 , 0.09] + + − ? + ? ?
Zijlstra 2009 25.1 9.7 208 29.4 11 214 15.5% -0.41 [-0.61 , -0.22] + + − ? + + +
Subtotal (95% CI) 691 689 77.1% -0.24 [-0.46 , -0.02]
Total (95% CI) 902 882 100.0% -0.24 [-0.41 , -0.07]

Test for overall effect: Z = 2.82 (P = 0.005) -1 -0.5 0 0.5 1
Risk of bias legend

(G) Other bias
Informed decisions.
Analysis 2.2. Comparison 2: Fear of falling: sustainability of effects, up to 6 months'

postintervention, Outcome 2: Fear of falling: subgrouped according to control
2.2.1 Usual care

Arkkukangas 2019 -96 25 42 -99 26 44 8.7% 0.12 [-0.31 , 0.54] + + − ? + + +
Dorresteijn 2016 31.98 10.9 141 35.86 11.1 171 14.5% -0.35 [-0.58 , -0.13] + + − ? + + +
Freiberger 2012 -141.3 22.8 71 -146.9 15.5 63 10.8% 0.28 [-0.06 , 0.62] + + − ? + + +
Gitlin 2006 -7.79 1.83 154 -7.45 2.13 146 14.4% -0.17 [-0.40 , 0.06] + + − ? + ? +
Huang 2011 (1) -99.14 11.66 56 -88.4 18.71 30 8.0% -0.73 [-1.19 , -0.28] + + − ? + ? +
Huang 2011 (2) -90.88 15.72 60 -88.4 18.71 30 8.4% -0.15 [-0.59 , 0.29] + + − ? + ? +
Parry 2016a -5.56 8.3335 151 -2.83 9.504 163 14.5% -0.30 [-0.53 , -0.08] + + − − − + +
Zijlstra 2009 25.1 9.7 208 29.4 11 214 15.5% -0.41 [-0.61 , -0.22] + + − ? + + +
Subtotal (95% CI) 883 861 94.8% -0.23 [-0.40 , -0.05]
2.2.2 Placebo
Wetherell 2018 31.35 4.7719 19 34.1 5.0528 21 5.2% -0.55 [-1.18 , 0.09] + + − ? + ? ?
Subtotal (95% CI) 19 21 5.2% -0.55 [-1.18 , 0.09]
Total (95% CI) 902 882 100.0% -0.24 [-0.41 , -0.07]

Footnotes
(2) CBT only
Risk of bias legend

(G) Other bias
Informed decisions.
Analysis 2.3. Comparison 2: Fear of falling: sustainability of effects, up to 6 months' postintervention,

Outcome 3: Fear of falling: subgrouped according to AMB versus non-AMB based interventions


Arkkukangas 2019 -96 25 42 -99 26 44 8.7% 0.12 [-0.31 , 0.54]
Gitlin 2006 -7.79 1.83 154 -7.45 2.13 146 14.4% -0.17 [-0.40 , 0.06]
Huang 2011 (1) -99.14 11.66 56 -88.4 18.71 30 8.0% -0.73 [-1.19 , -0.28]
Huang 2011 (2) -90.88 15.72 60 -88.4 18.71 30 8.4% -0.15 [-0.59 , 0.29]
Parry 2016a -5.56 8.3335 151 -2.83 9.504 163 14.5% -0.30 [-0.53 , -0.08]
Wetherell 2018 31.35 4.7719 19 34.1 5.0528 21 5.2% -0.55 [-1.18 , 0.09]
Subtotal (95% CI) 482 434 59.2% -0.26 [-0.46 , -0.07]

Dorresteijn 2016 31.98 10.9 141 35.86 11.1 171 14.5% -0.35 [-0.58 , -0.13]
Freiberger 2012 -141.3 22.8 71 -146.9 15.5 63 10.8% 0.28 [-0.06 , 0.62]
Zijlstra 2009 25.1 9.7 208 29.4 11 214 15.5% -0.41 [-0.61 , -0.22]
Subtotal (95% CI) 420 448 40.8% -0.19 [-0.54 , 0.17]
Total (95% CI) 902 882 100.0% -0.24 [-0.41 , -0.07]

Footnotes
(2) CBT only
Informed decisions.
Analysis 2.4. Comparison 2: Fear of falling: sustainability of effects, up to 6 months' postintervention,

Outcome 4: Fear of falling: subgrouped according to group versus individual interventions

Arkkukangas 2019 -96 25 42 -99 26 44 8.7% 0.12 [-0.31 , 0.54] + + − ? + + +
Dorresteijn 2016 31.98 10.9 141 35.86 11.1 171 14.5% -0.35 [-0.58 , -0.13] + + − ? + + +
Gitlin 2006 -7.79 1.83 154 -7.45 2.13 146 14.4% -0.17 [-0.40 , 0.06] + + − ? + ? +
Parry 2016a -5.56 8.3335 151 -2.83 9.504 163 14.5% -0.30 [-0.53 , -0.08] + + − − − + +
Wetherell 2018 31.35 4.7719 19 34.1 5.0528 21 5.2% -0.55 [-1.18 , 0.09] + + − ? + ? ?
Subtotal (95% CI) 507 545 57.3% -0.25 [-0.39 , -0.10]

Freiberger 2012 -141.3 22.8 71 -146.9 15.5 63 10.8% 0.28 [-0.06 , 0.62] + + − ? + + +
Huang 2011 (1) -99.14 11.66 56 -88.4 18.71 30 8.0% -0.73 [-1.19 , -0.28] + + − ? + ? +
Huang 2011 (2) -90.88 15.72 60 -88.4 18.71 30 8.4% -0.15 [-0.59 , 0.29] + + − ? + ? +
Zijlstra 2009 25.1 9.7 208 29.4 11 214 15.5% -0.41 [-0.61 , -0.22] + + − ? + + +
Subtotal (95% CI) 395 337 42.7% -0.25 [-0.64 , 0.15]
Total (95% CI) 902 882 100.0% -0.24 [-0.41 , -0.07]

Footnotes
(2) CBT only
Risk of bias legend

(G) Other bias
Comparison 3. Fear of falling: sustainability of effects, more than 6 months' postintervention
pants
3.1 Fear of falling: subgrouped ac- 5 1185 Std. Mean Difference (IV, Ran- -0.28 [-0.40, -0.15]
cording to intervention approach dom, 95% CI)
3.1.1 Sustainability of effects, CBT on- 1 314 Std. Mean Difference (IV, Ran- -0.38 [-0.60, -0.15]
ly dom, 95% CI)
3.1.2 Sustainability of effects, CBT 4 871 Std. Mean Difference (IV, Ran- -0.24 [-0.39, -0.08]
with exercise dom, 95% CI)
3.2 Fear of falling: subgrouped 5 1185 Std. Mean Difference (IV, Ran- -0.28 [-0.40, -0.15]
according to "A Matter of Bal- dom, 95% CI)
ance" (AMB) versus non-AMB based
interventions
3.2.1 Non AMB-based interventions 2 400 Std. Mean Difference (IV, Ran- -0.16 [-0.64, 0.31]
dom, 95% CI)
Informed decisions.
pants
3.2.2 AMB-based interventions 3 785 Std. Mean Difference (IV, Ran- -0.29 [-0.43, -0.14]
dom, 95% CI)
3.3 Fear of falling: subgrouped ac- 5 1185 Std. Mean Difference (IV, Ran- -0.28 [-0.40, -0.15]
cording to group versus individual in- dom, 95% CI)
terventions
3.3.1 Individual intervention 3 712 Std. Mean Difference (IV, Ran- -0.27 [-0.50, -0.03]
dom, 95% CI)
3.3.2 Group intervention 2 473 Std. Mean Difference (IV, Ran- -0.24 [-0.42, -0.06]
dom, 95% CI)
Analysis 3.1. Comparison 3: Fear of falling: sustainability of effects, more than 6 months'
postintervention, Outcome 1: Fear of falling: subgrouped according to intervention approach

3.1.1 Sustainability of effects, CBT only

Parry 2016a -5.68 10.0748 151 -2.22 8.2109 163 26.3% -0.38 [-0.60 , -0.15]
Subtotal (95% CI) 151 163 26.3% -0.38 [-0.60 , -0.15]
3.1.2 Sustainability of effects, CBT with exercise

Arkkukangas 2019 -96 25 42 -99 26 44 8.5% 0.12 [-0.31 , 0.54]
Dorresteijn 2016 31.98 10.9 141 35.86 11.1 171 26.0% -0.35 [-0.58 , -0.13]
Freiberger 2012 -146.9 15.5 32 -141.3 22.8 36 6.8% -0.28 [-0.76 , 0.20]
Zijlstra 2009 26.3 10.9 209 28.9 11 196 32.4% -0.24 [-0.43 , -0.04]
Subtotal (95% CI) 424 447 73.7% -0.24 [-0.39 , -0.08]
Total (95% CI) 575 610 100.0% -0.28 [-0.40 , -0.15]

Test for overall effect: Z = 4.25 (P < 0.0001) -2 -1 0 1 2
Informed decisions.
Analysis 3.2. Comparison 3: Fear of falling: sustainability of effects, more

than 6 months' postintervention, Outcome 2: Fear of falling: subgrouped
according to "A Matter of Balance" (AMB) versus non-AMB based interventions


Arkkukangas 2019 -96 25 42 -99 26 44 8.5% 0.12 [-0.31 , 0.54]
Parry 2016a -5.68 10.0748 151 -2.22 8.2109 163 26.3% -0.38 [-0.60 , -0.15]
Subtotal (95% CI) 193 207 34.8% -0.16 [-0.64 , 0.31]

Dorresteijn 2016 31.98 10.9 141 35.86 11.1 171 26.0% -0.35 [-0.58 , -0.13]
Freiberger 2012 -146.9 15.5 32 -141.3 22.8 36 6.8% -0.28 [-0.76 , 0.20]
Zijlstra 2009 26.3 10.9 209 28.9 11 196 32.4% -0.24 [-0.43 , -0.04]
Subtotal (95% CI) 382 403 65.2% -0.29 [-0.43 , -0.14]
Total (95% CI) 575 610 100.0% -0.28 [-0.40 , -0.15]

Analysis 3.3. Comparison 3: Fear of falling: sustainability of effects, more than 6 months' postintervention,
Outcome 3: Fear of falling: subgrouped according to group versus individual interventions


Arkkukangas 2019 -96 25 42 -99 26 44 8.5% 0.12 [-0.31 , 0.54]
Dorresteijn 2016 31.98 10.9 141 35.86 11.1 171 26.0% -0.35 [-0.58 , -0.13]
Parry 2016a -5.68 10.0748 151 -2.22 8.2109 163 26.3% -0.38 [-0.60 , -0.15]
Subtotal (95% CI) 334 378 60.9% -0.27 [-0.50 , -0.03]

Freiberger 2012 -146.9 15.5 32 -141.3 22.8 36 6.8% -0.28 [-0.76 , 0.20]
Zijlstra 2009 26.3 10.9 209 28.9 11 196 32.4% -0.24 [-0.43 , -0.04]
Subtotal (95% CI) 241 232 39.1% -0.24 [-0.42 , -0.06]
Total (95% CI) 575 610 100.0% -0.28 [-0.40 , -0.15]

Comparison 4. Secondary outcomes
pants
4.1 Activity avoidance: imme- 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected
diate postintervention
Informed decisions.
pants
4.2 Occurrence of falls: imme- 5 1119 Risk Ratio (M-H, Random, 95% CI) 0.96 [0.66, 1.39]
diate postintervention
4.2.1 CBT only 1 90 Risk Ratio (M-H, Random, 95% CI) 0.50 [0.21, 1.20]
4.2.2 CBT with exercise inter- 5 1029 Risk Ratio (M-H, Random, 95% CI) 1.04 [0.70, 1.53]
vention
4.3 Depression: immediate 2 404 Std. Mean Difference (IV, Random, -0.41 [-0.60, -0.21]
postintervention 95% CI)
95% CI)
4.3.2 CBT with exercise 1 90 Std. Mean Difference (IV, Random, -0.41 [-0.84, 0.02]
95% CI)
4.4 Anxiety: immediate postin- 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected
tervention
4.5 Quality of life: immediate 4 701 Std. Mean Difference (IV, Random, -0.24 [-0.51, 0.04]
postintervention 95% CI)
4.5.1 CBT only 3 472 Std. Mean Difference (IV, Random, -0.04 [-0.23, 0.14]
95% CI)
4.5.2 CBT with exercise 3 229 Std. Mean Difference (IV, Random, -0.47 [-0.98, 0.05]
95% CI)
Analysis 4.1. Comparison 4: Secondary outcomes, Outcome 1: Activity avoidance: immediate postintervention
Intervention Control Mean Difference Mean Difference

Study or Subgroup Mean SD Total Mean SD Total IV, Fixed, 95% CI IV, Fixed, 95% CI
Dorresteijn 2016 26.17 9.6 141 28.74 9.2 171 -2.57 [-4.67 , -0.47]
-10 -5 0 5 10
Favours intervention Favours control
Informed decisions.
Analysis 4.2. Comparison 4: Secondary outcomes, Outcome 2: Occurrence of falls: immediate postintervention
Intervention Control Risk Ratio Risk Ratio

Study or Subgroup Events Total Events Total Weight M-H, Random, 95% CI M-H, Random, 95% CI
4.2.1 CBT only

Huang 2011 8 60 8 30 10.9% 0.50 [0.21 , 1.20]
Subtotal (95% CI) 60 30 10.9% 0.50 [0.21 , 1.20]
Total events: 8 8
4.2.2 CBT with exercise intervention

Arkkukangas 2019 32 42 19 44 21.6% 1.76 [1.21 , 2.58]
Dorresteijn 2016 94 166 106 180 26.1% 0.96 [0.80 , 1.15]
Huang 2011 3 56 8 30 6.7% 0.20 [0.06 , 0.70]
Wetherell 2018 9 19 4 21 9.2% 2.49 [0.91 , 6.77]
Zijlstra 2009 91 232 117 239 25.6% 0.80 [0.65 , 0.98]
Subtotal (95% CI) 515 514 89.1% 1.04 [0.70 , 1.53]
Total events: 229 254
Total (95% CI) 575 544 100.0% 0.96 [0.66 , 1.39]

Total events: 237 262
Heterogeneity: Tau² = 0.13; Chi² = 24.64, df = 5 (P = 0.0002); I² = 80% 0.05 0.2 1 5 20
Test for overall effect: Z = 0.23 (P = 0.82) Favours intervention Favours control
Test for subgroup differences: Chi² = 2.22, df = 1 (P = 0.14), I² = 55.0%
Analysis 4.3. Comparison 4: Secondary outcomes, Outcome 3: Depression: immediate postintervention

4.3.1 CBT only

Parry 2016a -1.16 3.5448 151 0.1 2.6508 163 78.7% -0.40 [-0.63 , -0.18]
Subtotal (95% CI) 151 163 78.7% -0.40 [-0.63 , -0.18]
4.3.2 CBT with exercise

Resnick 2008 0.41 0.79 56 0.79 1.1 34 21.3% -0.41 [-0.84 , 0.02]
Subtotal (95% CI) 56 34 21.3% -0.41 [-0.84 , 0.02]
Total (95% CI) 207 197 100.0% -0.41 [-0.60 , -0.21]

Informed decisions.
Analysis 4.4. Comparison 4: Secondary outcomes, Outcome 4: Anxiety: immediate postintervention
Intervention Control Mean Difference Mean Difference

Study or Subgroup Mean SD Total Mean SD Total IV, Fixed, 95% CI IV, Fixed, 95% CI
Parry 2016a -0.49 3.2427 164 -0.55 2.9915 180 0.06 [-0.60 , 0.72]
-2 -1 0 1 2
Favours intervention Favours control
Analysis 4.5. Comparison 4: Secondary outcomes, Outcome 5: Quality of life: immediate postintervention

4.5.1 CBT only

Huang 2011 -53.8 10.32 60 -53.08 6.95 30 17.7% -0.08 [-0.51 , 0.36]
Parry 2016a -1.39 11.6089 164 -0.99 10.1304 180 26.7% -0.04 [-0.25 , 0.17]
Reinsch 1992 2.3 0.9 28 2.3 0.9 10 10.1% 0.00 [-0.72 , 0.72]
Subtotal (95% CI) 252 220 54.4% -0.04 [-0.23 , 0.14]
4.5.2 CBT with exercise

Huang 2011 -58.54 5.51 56 -53.08 6.95 30 16.8% -0.89 [-1.36 , -0.43]
Reinsch 1992 2 0.7 43 2.3 0.9 10 10.7% -0.40 [-1.09 , 0.29]
Resnick 2008 -14.65 3.3 56 -14.3 3.1 34 18.1% -0.11 [-0.53 , 0.32]
Subtotal (95% CI) 155 74 45.6% -0.47 [-0.98 , 0.05]
Total (95% CI) 407 294 100.0% -0.24 [-0.51 , 0.04]

Test for subgroup differences: Chi² = 2.32, df = 1 (P = 0.13), I² = 56.9% Favours intervention Favours control
ADDITIONAL TABLES
Table 1. Summary table, included study characteristics
Study Total Mean Number Design Intervention Control Home Total duration and in- Thera- Base- FoF out-
Library
Cochrane
number Age of arms types type treat- tensity of interventions pist back- line fall come
ment ground rates mea-
sures
Arkkukan- 124 > 75 3 (CBT RCT Individual, CBT Usual Yes 6 hours, bimonthly Physiother- 43.2% FES-S
gas 2019 years only, with exercise care treatment, for 12 weeks apists
Better health.
Informed decisions.
Trusted evidence.
CBT with
exercise)
Dor- 389 > 70 2 RCT Individual, CBT Usual Yes 15.5 hours, bimonthly Nurses 62.2% FES-I
resteijn years with exercise care treatment, for 16 weeks
2016 (AMB-based)
Freiberg- 280 > 70 4 Clus- Groups of up to Usual No 32 hours, weekly treat- Trained "fall 26.1% ABC
er 2012 years ter-RCT 15 people, CBT care ment, for 16 weeks prevention
with exercise instructors"
(AMB-based)

Freiberg- 378 > 65 2 RCT Groups of 5–15 Usual No 16 hours, weekly treat- Physiother- 52.3% FES-I
er 2013 years people, CBT with care ment, for 16 weeks apists and
exercise sports scien-
tists
Gitlin 319 > 70 2 RCT Individual, CBT Usual Yes 7.5 hours, monthly treat- Physiother- — FES
2006 years with exercise care ment, for 24 weeks apists and
occupation-
al therapists
Huang 186 > 60 3 RCT Groups 8–12 peo- Usual No 8–12 hours, weekly Nurses 17.8% FES
2011 years ple, CBT with ex- care treatment, for 8 weeks

ercise and CBT
only
Parry 415 > 60 2 RCT Individual, CBT Usual No 6.75 hours, weekly treat- Licenced — FES-I
2016a years only care ment, for 8 weeks psychother-
apists
Reinsch 230 > 60 4 (CBT Clus- Groups 5–25 peo- Social No 1 hour, 3 days per week, — 27.1% Sin-
1992 years only, ter-RCT ple, CBT with ex- contact for 1 year gle-item
CBT with ercise and CBT and dis- instru-
exercise, only cussion ments
group
72
Table 1. Summary table, included study characteristics (Continued)
exercise
only)
Library
Cochrane
Resnick 166 > 60 2 Clus- Groups, CBT with Nutrition No 12–18 hours, biweekly Nutritionists — Sin-
2008 years ter-RCT exercise educa- treatment, for 12 weeks or trained gle-item
tion laypeople instru-
ments
Tennst- 434 > 60 2 Clus- Groups, CBT with Social No 16 hours, biweekly treat- Laypeople 24.9% mFES
Better health.
Informed decisions.
Trusted evidence.
edt 1998 years ter-RCT exercise contact ment, for 8 weeks
and dis-
cussion
group
Wetherell 42 > 65 2 RCT Individual, CBT Fall pre- Yes 8 hours, weekly treat- Physiother- 64.3% FES-I
2018 years with exercise vention ment, for 8 weeks apists with
educa- supervision
tion from psy-
chothera-
pists

Zijlstra 540 > 70 2 RCT Groups, CBT with Usual no 16 hours, weekly treat- Nurses 55.6% mFES
2009 years exercise (AMB- care ment, over 8 weeks
based)
ABC: Activities-Specific Balance Confidence Scale; AMB: "A Matter of Balance"; CBT: cognitive behavioural therapy; FES: Falls Efficacy Scale; FES-I: FES-International; FES-IAB:
FES International Avoidance Behaviour; FES-S: Falls Efficacy Scale Swedish; FoF: fear of falling; mFES: Modified FES; RCT: randomised controlled trial; Single-Item Instrument:
two instruments.

73
Informed decisions.
Table 2. Fear of falling measures

Measure Studies that used Score interpreta- Description of measure
the measure tion
Falls Efficacy Scale Gitlin 2006; Huang Lower scores repre- This self-administered questionnaire is the original FoF scale
(FES) (Tinetti 1990) 2011 sent lower concerns for which there are many derivates. Items represent the 10
about falling (low most important activities essential to independent living. This
FoF) instrument has 10 items, rated on a 1 (not at all concerned) to
10 (very concerned) point Likert scale, with a total range be-
tween 10 and 100.
Note: Gitlin 2006 added 3 items to this scale from the Activi-
ties-Specific Balance Confidence Scale.
FES-Internation- Dorresteijn 2016; Lower scores repre- A self-administered questionnaire in its original version and
al (FES-I) (Yardley Freiberger 2013; sent lower concerns an expanded, modified version of the FES. It uses 6 additional
2005) Parry 2016a; about falling (low items representing various levels of challenging and social ac-
Wetherell 2018 FoF) tivities (Moore 2008). The FES-I instrument has 16 items, rated
on a 1 (not at all concerned) to 4 (very concerned) point Likert
scale, with a total range between 4 and 64.
Modified FES Tennstedt 1998; Zi- Lower scores repre- This self-administered questionnaire is an expanded version of
(mFES) (Hill 1996) jlstra 2009 sent lower concerns the FES with an additional 4 items representing outdoor activ-
about falling (low ities. This instrument has 14 items, rated on a 1 (not at all con-
FoF) cerned) to 4 (very concerned) point Likert scale, with a total
range between 4 and 64.
FES Swedish vari- Arkkukangas 2019 Lower scores repre- This self-administered questionnaire is a translated version of
ant (FES-S) (Hell- sent lower concerns the FES with 3 additional items, totalling 13 items rated on a 0
ström 1999; Hell- about falling (low (not confident at all) to 10 (completely confident) point Likert
ström 2002) FoF) scale, with a total range between 0 and 130.
Activities-Specific Freiberger 2012 A high score repre- This interviewer-administered questionnaire has 16 items, rat-
Balance Confidence sents a high level of ed on a 0% (no confidence) to 100% (completely confident)
Scale (ABC) (Powell physical function- continuum, with a total score ranging between 0 and 100 (cal-
1995): ing (low FoF) culated by the total score divided by 16).
Single-Item Instru- Reinsch 1992; A high score repre- Reinsch 1992 used a single-item question rated on a 5-point
ments Resnick 2008 sents high FoF scale regarding worry about falling has level of fear ranges from
1 = not at all worried to 5 = extremely worried.
Resnick 2008 used a single-item question asking respondents

"How would you rate your fear of falling" on a scale ranging
from 0 (no fear) to 4 (very afraid) (Resnick 2008).
FoF: fear of falling.
Table 3. Summary table, sensitivity analysis

Analysis Outcomes (SMD)
Immediate postintervention effects
Removing the studies causing considerable hetero- −0.30 (95% CI −0.39 to −0.22; P = 0.65, I2 = 0%; 12 studies, 2228 participants)
geneity (outliers)
Informed decisions.
Table 3. Summary table, sensitivity analysis (Continued)
Trials with high risks of bias (i.e. ≥ 3 domains of high −0.17 (95% CI −0.32 to −0.01; P = 0.04, I2 = 50%; 9 studies, 1625 participants)
risk of bias)
Comparing fixed-effect and random-effects estimates −0.26 (95% CI −0.35 to −0.18; P = 0.03, I2 = 48%; 13 studies, 2357 partici-
pants)
Trials where FoF was not the primary outcome −0.23 (95% CI −0.37 to −0.10; P = 0.01, I2 = 58%; 12 studies, 2266 partici-
pants)
Where non-FES-based questionnaires were used as −0.31 (95% CI −0.40 to −0.20; P = 0.48, I2 = 0%; 9 studies, 2047 participants)
measures
Clustered studies for potential ICC issues −0.31 (95% CI −0.40 to −0.20; P = 0.48, I2 = 0%; 9 studies, 2047 participants)
Trials where active control groups were used −0.25 (95% CI −0.40 to −0.10; P = 0.006, I2 = 63%; 9 studies, 2136 partici-
pants)
Sustainability of effects, up to 6 months' postintervention
geneity (outliers)
Trials with high risks of bias (i.e. ≥ 3 domains of high −0.23 (95% CI −0.43 to −0.03; P = 0.003, I2 = 68%; 8 studies, 1470 partici-
risk of bias) pants)
pants)
pants)
Sustainability of effects, more than 6 months' postintervention
geneity (outliers)
risk of bias)
Comparing fixed-effect and random-effects estimates −0.28 (95% CI −0.40 to −0.17; P = 0.32, I2 = 14%; 5 studies, 1185 participants)
AMB: "A Matter of Balance"; CI: confidence interval; SMD: standardised mean difference.
Table 4. Summary table, subgroup analysis

Analysis Subgroup Outcomes (SMD)
Age group < 75 years −0.11 (95% CI −0.54 to −0.32; 1 study, 90 participants)
≥ 75 years −0.31 (95% CI −0.40 to −0.22; P = 0.61, I2 = 0%; 9 studies, 1962 participants)
Type of control group Placebo control −0.32 (95% CI −0.41 to −0.23; P = 0.45, I2 = 0%; 8 studies, 2007 participants)
Informed decisions.
Table 4. Summary table, subgroup analysis (Continued)
Usual care −0.13 (95% CI −0.42 to −0.16; P = 0.94, I2 = 0%; 4 studies, 221 participants)
Interventions based on AMB-based studies −0.31 (95% CI −0.45 to −0.17; P = 0.44, I2 = 0%; 2 studies, 783 participants)
AMB
Non-AMB studies −0.30 (95% CI −0.41 to −0.19; P = 0.53, I2 = 0%; 10 studies, 1445 participants)
Group vs individual in- Group −0.30 (95% CI −0.42 to −0.18; P = 0.65, I2 = 0%; 7 studies, 1125 participants)
terventions
Individual −0.30 (95% CI −0.43 to −0.18; P = 0.34, I2 = 11%; 5 studies, 1103 participants)
Type of control group Placebo control −0.55 (95% CI −1.18 to −0.09; 1 study, 40 participants)
AMB
terventions
AMB
Non-AMB studies −0.16 (95% CI −0.64 to 0.31; P = 0.04, I2 = 76%; 2 studies, 400 participants)
Group vs individual in- Group −0.24 (95% CI −0.43 to −0.04; 1 study, 405 participants)
terventions
AMB: "A Matter of Balance".
Table 5. Mean difference outcomes, immediate postintervention effects for depression
Study Intervention Intervention Intervention Control mean Control SD Control total Mean difference IV, random, 95% CI
mean SD total
Library
Cochrane
Parry 2016a −1.16 3.54 151 0.1 2.65 163 −1.26 (95% CI −1.96 to −0.56)
Resnick 2008 0.41 0.79 56 0.79 1.1 34 −0.38 (95% CI −0.80 to 0.04)
Better health.
Informed decisions.
Trusted evidence.
CI: confidence interval; SD: standard deviation.

77
Informed decisions.
APPENDICES
Appendix 1. Search strategies

The searches were run in three stages: the first search was run in March 2021 and top-up searches were run in November 2021 and January
2023.
CENTRAL (CRS-Web)
Search 1
#1 MESH DESCRIPTOR Accidental Falls AND CENTRAL:TARGET (1542)

#2 MESH DESCRIPTOR Fear AND CENTRAL:TARGET (1401)
#3 MESH DESCRIPTOR Phobic Disorders AND CENTRAL:TARGET (1190)
#4 ( fright* or fear* or afraid or phobia*):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET (11990)
#5 #2 OR #3 OR #4 (12347)
#6 #1 AND #5 (211)
#7 ((fear* or fright* or afraid or phobia*) NEAR5 fall*):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET (794)
#8 (ptophobia or post fall syndrome):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET (6)
#9 ("Falls Efficacy Scale" or "Mobility Efficacy Scale" or "Survey of Activities and Fear of Falling in the Elderly" or "University of Illinois at
Chicago Fear of Falling Measure" or "SAFFE" or "UICFFM" or "Activities Specific Balance Confidence Scale" or "Confidence in Maintaining
Balance Scale" or "CON-Fbal"): AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET (576)
#10 #6 OR #7 OR #8 OR #9 (1158)
Search 2 (top-up search)
#11 16/03/2021_TO_11/11/2021:CRSCREATED AND CENTRAL:TARGET (76006)

#12 #10 AND #11 (92)
#11 11/11/2021_TO_10/01/2023:CRSCREATED AND CENTRAL:TARGET (159146)

#12 #10 AND #11 (242)
MEDLINE (Ovid)
Search 1
1 Accidental Falls/ (25255)

2 Fear/ (32944)
3 *Phobic Disorders/ (7675)
4 (fright* or fear* or afraid or phobia*).tw. (97554)
5 or/2-4 (109806)
6 1 and 5 (1405)
7 ((fear* or fright* or afraid or phobia*) adj5 fall*).tw. (2059)
8 ptophobia.tw. (2)
9 post fall syndrome.tw. (21)
10 ("Falls Efficacy Scale" or "Mobility Efficacy Scale" or "Survey of Activities and Fear of Falling in the Elderly" or "University of Illinois at
Balance Scale" or "CON-Fbal").tw. (935)
11 or/6-10 (2787)
12 randomized controlled trial.pt. (525030)
13 controlled clinical trial.pt. (94095)
14 randomized.ab. (512874)
15 placebo.ab. (216118)
16 drug therapy.fs. (2289844)
17 randomly.ab. (353192)
18 trial.ab. (543638)
19 groups.ab. (2167207)
20 or/12-19 (4941711)
21 exp animals/ not humans.sh. (4799766)
22 20 not 21 (4295798)
23 11 and 22 (974)
Informed decisions.
24 (202103* or 202104* or 202105* or 202106* or 202107* or 202108* or 202109* or 202110* or 202111*).ed,dt. (1797486)
25 23 and 24 (168)
24 (202111* or 202112* or 2022* or 2023*).ed,dt. (2360603)

25 23 and 24 (185)
Embase (Ovid)
Search 1
1 falling/ (42416)
2 fear/ (64015)
3 phobia/ (12015)
5 or/2-4 (146330)
6 1 and 5 (1628)
8 ptophobia.tw. (2)
9 post fall syndrome.tw. (32)
11 or/6-10 (4131)
12 Randomized controlled trial/ (647655)
13 Controlled clinical study/ (466777)
14 Random*.ti,ab. (1634169)
15 randomization/ (90450)
16 intermethod comparison/ (269883)
17 placebo.ti,ab. (316157)
18 (compare or compared or comparison).ti. (513990)
19 ((evaluated or evaluate or evaluating or assessed or assess) and (compare or compared or comparing or comparison)).ab. (2266187)
20 (open adj label).ti,ab. (86178)
21 ((double or single or doubly or singly) adj (blind or blinded or blindly)).ti,ab. (235902)
22 double blind procedure/ (179713)
23 parallel group*1.ti,ab. (27169)
24 (crossover or cross over).ti,ab. (107644)
25 ((assign* or match or matched or allocation) adj5 (alternate or group*1 or intervention*1 or patient*1 or subject*1 or
participant*1)).ti,ab. (348398)
26 (assigned or allocated).ti,ab. (410318)
27 (controlled adj7 (study or design or trial)).ti,ab. (370911)
28 (volunteer or volunteers).ti,ab. (249620)
29 trial.ti. (318749)
30 or/12-29 (4905825)
31 (exp animal/ or animal.hw. or nonhuman/) not (exp human/ or human cell/ or (human or humans).ti.) (6175541)
32 30 not 31 (4249381)
33 11 and 32 (1437)
34 2021*.dc,yr. (2140806)
35 33 and 34 (192)
34 (2021* or 2022* or 2023*).dc,yr. (4377860)

35 33 and 34 (378)
CINAHL Plus
Search 1
Informed decisions.
S1 (MH “Accidental Falls”) (23,704)

S2 (MH "fear") (14,065)
S3 (MH "Phobic Disorders") (2,484)
S4 TI (fright* or fear* or afraid or phobia*) OR AB (fright* or fear* or afraid or phobia*) (41,269)
S5 S2 OR S3 OR S4 (47,142)
S6 S1 and S5 (1,353)
S7 7 TI ((fear* or fright* or afraid or phobia*) N5 fall*) OR AB ((fear* or fright* or afraid or phobia*) N5 fall*) (1,523)
S8 TI ptophobia or AB ptophobia (1)
S9 TI post fall syndrome OR AB post fall syndrome (6)
S10 TI ("Falls Efficacy Scale" or "Mobility Efficacy Scale" or "Survey of Activities and Fear of Falling in the Elderly" or "University of Illinois at
Balance Scale" or "CON-Fbal") OR AB ("Falls Efficacy Scale" or "Mobility Efficacy Scale" or "Survey of Activities and Fear of Falling in the
Elderly" or "University of Illinois at Chicago Fear of Falling Measure" or "SAFFE" or "UICFFM" or "Activities Specific Balance Confidence
Scale" or "Confidence in Maintaining Balance Scale" or "CON-Fbal") (656)
S11 S6 OR S7 OR S8 OR S9 OR S10 (2,116)
S12 PT Clinical Trial (109,226)
S13 (MH “Clinical Trials+”) (315,777)
S14 TI clinical trial* OR AB clinical trial* (121,304)
S15 TI ( (single blind* or double blind*) ) OR AB ( (single blind* or double blind*) ) (50,549)
S16 TI random* OR AB random* (369,953)
S17 S12 OR S13 OR S14 OR S15 OR S16 (568,877)
S18 S11 AND S17 (463)
S19 EM 20210316-2021 (258,662)

S20 S18 AND S19 (25)
S19 EM 20211111-2023 (499,812)

S20 S18 AND S19 (56)
PsycINFO
Search 1
1 falls/ (3159)
2 fear/ (18562)
3 phobias/ (5365)
5 or/2-4 (101104)
6 1 and 5 (488)
8 (ptophobia or post fall syndrome).tw. (7)
10 or/6-9 (1008)
11 10 and 2021*.(sa_year) (37)
11 10 and 2021*:2023*.(sa_year). (123)
AMED
Search 1
1 accidental falls/ (2445)

2 fear/ (558)
3 phobic disorders/ (180)
Informed decisions.

5 or/2-4 (2418)
6 1 and 5 (249)
9 or/6-8 (429)
10 2021*.up,yr. (8807)
11 9 and 10 (23)
10 (2021* or 2022* or 2023*).up,yr. (19920)

11 9 and 10 (52)
WHO ICTRP
fall* AND fright* OR fall* AND fear* OR fall* AND afraid OR fall* AND phobia* (415)
ClinicalTrials.gov
(fall OR falls OR falling) AND (fright OR fear OR afraid OR phobia) | Interventional Studies (463)
(fall OR falls OR falling) AND (fright OR fear OR afraid OR phobia) | Interventional Studies First posted from 03/16/2021 to 11/11/2021 (41)
(fall OR falls OR falling) AND (fright OR fear OR afraid OR phobia) | Interventional Studies | First posted from 11/11/2021 to 01/10/2023 (99)
Appendix 2. Fear of falling measures
Measure Studies that used Score interpreta- Description of measure

the measure tion
Falls Efficacy Scale Gitlin 2006; Huang Lower scores repre- This self-administered questionnaire is the original FoF scale
(FES) (Tinetti 1990) 2011 sent lower concerns for which there are many derivates. Items represent the 10
about falling (low most important activities essential to independent living. This
FoF) instrument has 10 items, rated on a 1 (not at all concerned) to
10 (very concerned) point Likert scale, with a total range be-
tween 10 and 100.
Note: Gitlin 2006 added 3 items to this scale from the Activi-
ties-Specific Balance Confidence Scale.
FES-Internation- Dorresteijn 2016; Lower scores repre- A self-administered questionnaire in its original version and
al (FES-I) (Yardley Freiberger 2013; sent lower concerns an expanded, modified version of the FES. It uses 6 additional
2005) Parry 2016a; about falling (low items representing various levels of challenging and social ac-
Wetherell 2018 FoF) tivities (Moore 2008). The FES-I instrument has 16 items, rated
on a 1 (not at all concerned) to 4 (very concerned) point Likert
scale, with a total range between 4 and 64.
Modified FES Tennstedt 1998; Zi- Lower scores repre- This self-administered questionnaire is an expanded version of
(mFES) (Hill 1996) jlstra 2009 sent lower concerns the FES with an additional 4 items representing outdoor activ-
about falling (low ities. This instrument has 14 items, rated on a 1 (not at all con-
FoF) cerned) to 4 (very concerned) point Likert scale, with a total
range between 4 and 64.
FES Swedish vari- Arkkukangas 2019 Lower scores repre- This self-administered questionnaire is a translated version of
ant (FES-S) (Hell- sent lower concerns the FES with 3 additional items, totalling 13 items rated on a 0
ström 1999; Hell- about falling (low (not confident at all) to 10 (completely confident) point Likert
ström 2002) FoF) scale, with a total range between 0 and 130.
Informed decisions.
(Continued)
Activities-Specific Freiberger 2012 A high score repre- This interviewer-administered questionnaire has 16 items, rat-
Balance Confidence sents a high level of ed on a 0% (no confidence) to 100% (completely confident)
Scale (ABC) (Powell physical function- continuum, with a total score ranging between 0 and 100 (cal-
1995): ing (low FoF) culated by the total score divided by 16).
Single-Item Instru- Reinsch 1992; A high score repre- Reinsch 1992 used a single-item question rated on a 5-point
ments Resnick 2008 sents high FoF scale regarding worry about falling has level of fear ranges from
1 = not at all worried to 5 = extremely worried.
Resnick 2008 used a single-item question asking respondents

"How would you rate your fear of falling" on a scale ranging
from 0 (no fear) to 4 (very afraid) (Resnick 2008).
FOF: fear of falling.
Appendix 3. Summary table, sensitivity analysis
Analysis Outcomes (SMD)
geneity (outliers)
risk of bias)
pants)
Trials where FoF was not the primary outcome −0.23 (95% CI −0.37 to −0.10; P = 0.01, I2 = 58%; 12 studies, 2266 partici-
pants)
Where non-FES-based questionnaires were used as −0.31 (95% CI −0.40 to −0.20; P = 0.48, I2 = 0%; 9 studies, 2047 participants)
measures
Clustered studies for potential ICC issues −0.31 (95% CI −0.40 to −0.20; P = 0.48, I2 = 0%; 9 studies, 2047 participants)
pants)
geneity (outliers)
Trials with high risks of bias (i.e. ≥ 3 domains of high −0.23 (95% CI −0.43 to −0.03; P = 0.003, I2 = 68%; 8 studies, 1470 partici-
risk of bias) pants)
pants)
Informed decisions.
(Continued)
pants)
geneity (outliers)
risk of bias)
Comparing fixed-effect and random-effects estimates −0.28 (95% CI −0.40 to −0.17; P = 0.32, I2 = 14%; 5 studies, 1185 participants)
CI: confidence interval; FES: Falls Efficacy Scale; FoF: fear of falling; ICC: intracluster coefficient; SMD: standardised mean difference.
Appendix 4. Summary table, subgroup analysis, when outlier removed
Analysis Subgroup Outcomes (SMD)
Age group < 75 years −0.11 (95% CI −0.54 to −0.32; 1 study, 90 participants)
≥ 75 years −0.31 (95% CI −0.40 to −0.22; P = 0.61, I2 = 0%; 9 studies, 1962 participants)
Type of control group Placebo control −0.32 (95% CI −0.41 to −0.23; P = 0.45, I2 = 0%; 8 studies, 2007 participants)
AMB
terventions
Type of control group Placebo control −0.55 (95% CI −1.18 to −0.09; 1 study, 40 participants)
AMB
terventions
Informed decisions.
(Continued)
AMB
Non-AMB studies −0.16 (95% CI −0.64 to 0.31; P = 0.04, I2 = 76%; 2 studies, 400 participants)
Group vs individual in- Group −0.24 (95% CI −0.43 to −0.04; 1 study, 405 participants)
terventions
AMB: "A Matter of Balance"; CI: confidence interval; SMD: standardised mean difference.
Appendix 5. Mean difference outcomes, immediate postintervention effects for depression
Library
Cochrane
Study Intervention Intervention Intervention Control mean Control SD Control total Mean difference IV, random, 95% CI
mean SD total
Parry 2016a −1.16 3.54 151 0.1 2.65 163 −1.26 (95% CI −1.96 to −0.56)
Resnick 2008 0.41 0.79 56 0.79 1.1 34 −0.38 (95% CI −0.80 to 0.04)
Better health.
Informed decisions.
Trusted evidence.

85
Informed decisions.
CI: confidence interval; SD: standard deviation.
Appendix 6. Summary table, included study characteristics
Library
Cochrane
Study Total Mean Number Design Intervention Control Home Total duration and in- Thera- Base- FoF out-
number Age of arms types type treat- tensity of interventions pist back- line fall come
ment ground rates mea-
sures
Arkkukan- 124 > 75 3 (CBT RCT Individual, CBT Usual Yes 6 hours, bimonthly Physiother- 43.2% FES-S
gas 2019 years only, with exercise care treatment, for 12 weeks apists
Better health.
Informed decisions.
Trusted evidence.
CBT with
exercise)
Dor- 389 > 70 2 RCT Individual, CBT Usual Yes 15.5 hours, bimonthly Nurses 62.2% FES-I
resteijn years with exercise care treatment, for 16 weeks
2016 (AMB-based)
Freiberg- 280 > 70 4 Clus- Groups of up to Usual No 32 hours, weekly treat- Trained "fall 26.1% ABC
er 2012 years ter-RCT 15 people, CBT care ment, for 16 weeks prevention
with exercise instructors"
(AMB-based)

Freiberg- 378 > 65 2 RCT Groups of 5–15 Usual No 16 hours, weekly treat- Physiother- 52.3% FES-I
er 2013 years people, CBT with care ment, for 16 weeks apists and
exercise sports scien-
tists
Gitlin 319 > 70 2 RCT Individual, CBT Usual Yes 7.5 hours, monthly treat- Physiother- — FES
2006 years with exercise care ment, for 24 weeks apists and
occupation-
al therapists
Huang 186 > 60 3 RCT Groups 8–12 peo- Usual No 8–12 hours, weekly Nurses 17.8% FES
2011 years ple, CBT with ex- care treatment, for 8 weeks

ercise and CBT
only
Parry 415 > 60 2 RCT Individual, CBT Usual No 6.75 hours, weekly treat- Licenced — FES-I
2016a years only care ment, for 8 weeks psychother-
apists
Reinsch 230 > 60 4 (CBT Clus- Groups 5–25 peo- Social No 1 hour, 3 days per week, — 27.1% Sin-
1992 years only, ter-RCT ple, CBT with ex- contact for 1 year gle-item
CBT with ercise and CBT and dis- instru-
exercise, only ments
87
(Continued)
exercise cussion
only) group
Library
Cochrane
Resnick 166 > 60 2 Clus- Groups, CBT with Nutrition No 12–18 hours, biweekly Nutritionists — Sin-
2008 years ter-RCT exercise educa- treatment, for 12 weeks or trained gle-item
tion laypeople instru-
ments
Tennst- 434 > 60 2 Clus- Groups, CBT with Social No 16 hours, biweekly treat- Laypeople 24.9% mFES
Better health.
Informed decisions.
Trusted evidence.
edt 1998 years ter-RCT exercise contact ment, for 8 weeks
and dis-
cussion
group
Wetherell 42 > 65 2 RCT Individual, CBT Fall pre- Yes 8 hours, weekly treat- Physiother- 64.3% FES-I
2018 years with exercise vention ment, for 8 weeks apists with
educa- supervision
tion from psy-
chothera-
pists

Zijlstra 540 > 70 2 RCT Groups, CBT with Usual no 16 hours, weekly treat- Nurses 55.6% mFES
2009 years exercise (AMB- care ment, over 8 weeks
based)

88
Informed decisions.
ABC: Activities-Specific Balance Confidence Scale; AMB: "A Matter of Balance"; CBT: cognitive behavioural therapy; FES: Falls Efficacy Scale;
FES-I: FES-International; FES-IAB: FES International Avoidance Behaviour; FES-S: Falls Efficacy Scale Swedish; FoF: fear of falling; mFES:
Modified FES; RCT: randomised controlled trial; Single-Item Instrument: two instruments.
HISTORY
Protocol first published: Issue 3, 2021
CONTRIBUTIONS OF AUTHORS
EL: lead investigator, searched literature, checked reference lists for additional studies, database management, data extraction, analysis,
writing manuscript, revision of manuscript. EL is the guarantor of the review.
PU: searched literature, checked reference lists for additional studies, database management, data extraction, writing manuscript, revision
of manuscript
WS: provided methodological expertise and statistical advice, revision of manuscript
DD: contributed to drafting the protocol, provided statistical advice, revision of manuscript
MD: contributed to drafting the protocol, revision of manuscript
GK: contributed to drafting the protocol, adjudicated on papers for inclusion, risk of bias assessment, revision of manuscript
GARZ: contributed to drafting the protocol, revision of manuscript
KH: adjudicated on papers for inclusion, data extraction, data analysis, writing manuscript, revision of manuscript
SK: lead supervisor of review team, co-ordinated protocol design, database management, data extraction, analysis, writing manuscript,
revision of manuscript
DECLARATIONS OF INTEREST
EL: was granted funding from the Age Stifung (Kirchgasse 42, 8001 Zürich, Switzerland) during the process of this review for developing a
cognitive behavioural therapy (CBT) intervention for reducing fear of falling in nursing home residents, which when the study is conducted,
due to a different population would not fulfil the inclusion criteria of this review.
PU: none.
WS: none.
DD: none.
MD: none.
GK: none.
GARZ: was involved in conducting a study that was included in the review (Zijlstra 2009). She was independent of the study selection
decision, risk of bias assessment, and data extraction for this study.
KH: none.
SK: was granted funding from the Age Stifung (Kirchgasse 42, 8001 Zürich, Switzerland) during the process of this review for developing a
CBT intervention for reducing fear of falling in nursing home residents, which when the study is conducted, due to a different population
would not fulfil the inclusion criteria of this review.
SOURCES OF SUPPORT
Internal sources
• Department of Old Age Psychiatry and Psychotherapy, University Hospital of Psychiatry, Bern, Switzerland
Salary support for EL, L Novak (contributor to the protocol), T Wirth (contributor to the protocol), SK.
• University of Bern, Graduate School for Health Sciences (GHS), Other
Library resources
• AGAPLESION Bethesda Clinic Ulm, Ulm, Germany, Other
Informed decisions.
Salary support MD, DD

• Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center – University of Freiburg, Freiburg, Germany, Other
Salary support SV, library resources

• Geriatric Research Institute, University of Ulm, Ulm, Germany, Other
Library resources
External sources
• None, Other
No specific grants from any funding agency in the public, commercial, or non-profit sectors were received.
DIFFERENCES BETWEEN PROTOCOL AND REVIEW

We made the following changes from the published protocol (Lenouvel 2021b).
• Title: we changed the title from "Cognitive behavioural interventions for reducing fear of falling in older people living in the community"
to "Cognitive behavioural therapy (CBT) with and without exercise to reduce fear of falling in older people living in the community."
Cognitive behavioural therapy is commonly referred to as only 'CBT'. The addition of CBT in the title was to add clarity and ease of
identifying this article when searching CBT. The addition of 'with and without exercise' is to better reflect the objective of the review:
to assess the effects of CBT only and CBT with exercise.
• Introduction: we modified the text to improve readability.
• Methods: we reformulated the text to improve readability.
◦ We removed the definitions of cluster and quasi-experiment studies, as we consider this to be superfluous.
◦ We specified the definition of comparative studies as "… studies that did not include CBT with or without exercise interventions."
This clarifies the inclusion of relevant articles, such as Huang 2011, which is a three-arm study, comparing CBT alone, and CBT with
exercise, with a control group.
◦ Types of interventions: we removed the SAFFE questionnaire as a potential primary outcome measure of FoF, as it appeared in both
primary and secondary outcomes. We added the FES-IAB to possible secondary outcome measures for activity avoidance.
◦ We considered only English and German language articles for inclusion due to language limitations of the review team.
◦ We specified how studies with multiple arms would be analysed in the quantitative synthesis.
◦ Sensitivity analysis of missing data was not performed (removing quasi-RCTs).
◦ Unit of analysis issues; we specified how unit of analysis issues would be accounted for and mentioned how we would incorporate
studies with multiple arms that were not cross-over studies.
◦ We removed sustainability of effects as a secondary outcomes. This was due to unanticipated generalised insufficiency of data, due
to a low number of studies reporting the secondary outcomes, and a low number of participants. We did not consider that reporting
of sustainability of effects of secondary outcomes added value to this review.
◦ Measurement of effect; we specified how sustainability of effect was classified as less than six months and six months or greater after
the end of treatment. We considered this categorisation would better demonstrate the effects of FoF interventions over time, taking
into account the variations in measurements between studies.
◦ We removed "and short- and long-term measures of well-being and QoL" from the secondary analyses, as this was a repetition from
one of the prementioned secondary outcomes (QoL).
◦ Summary of findings 1: following the reasoning mentioned above, we added sustainability of effects, more than six months'
postintervention. We did not include anxiety outcomes, as we considered this secondary outcome was less relevant, particularly as
the review did not yield significant data.
◦ We removed the characterisation of exercise components using the ProFaNE taxonomy, as we considered that the focus of this review
was on the CBT interventions rather than the exercise components, and as such beyond the scope of this review.
◦ We added an explanation of how we calculated the change score, as it was missing in the original protocol.
◦ We removed the mention of searching the Cochrane Bone, Joint and Muscle Trauma (BJMT) Group Specialised Register, as Cochrane
CENTRAL included the Cochrane BJMT group register.
• Analysis
◦ Subgroup analysis
▪ Due to insufficient data in included studies, baseline fall risk, cognitive state, and sex could not be included for analysis. Baseline
FoF could not be included due to difficulties in comparing the different FoF measures.
▪ We presented in the analyses CBT-only interventions and CBT with exercise interventions subgroups. We considered this clinically
meaningful, illustrating the effects of these two major classes of interventions.
◦ Sensitivity analysis
Informed decisions.
▪ We conducted additional sensitivity analyses post hoc in trials for primary outcomes where: 1. FoF was not the primary outcome;
2. studies were clustered (due to potential ICC issues); 3. when none-FES based questionnaires were used as measures, and 4. for
trials where active control groups were used. We included these analyses as we considered it would improve the quality of the
review. As there were no quasi-RCTs in this study, they could not undergo sensitivity analysis, and as such were not included in
the list of sensitivity analyses.
• Outcomes for presentation in Summary of findings 1
◦ We added the outcome sustainability of effects more than six months, as we considered this more clinically relevant to the long-term
benefits of CBT interventions for reducing FoF. We removed anxiety from the secondary outcomes listed in the Summary of findings 1.
INDEX TERMS
Medical Subject Headings (MeSH)

*Cognitive Behavioral Therapy; *Exercise; Fear
MeSH check words

Aged; Aged, 80 and over; Female; Humans

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Cochrane

Cognitive behavioural therapy (CBT) with and without exercise

Lenouvel E, Ullrich P, Siemens W, Dallmeier D, Denkinger M, Kienle G, Zijlstra GAR, Hauer K,

Cognitive behavioural therapy (CBT) with and without exercise to reduce

Contact: Eric Lenouvel, eric.lenouvel@upd.unibe.ch.

Editorial group: Cochrane Bone, Joint and Muscle Trauma Group.

Data collection and analysis

No studies reported adverse effects due to their interventions.

PLAIN LANGUAGE SUMMARY

– It is unclear if the frequency of falls is reduced following treatment.

What is fear of falling?

How is the condition treated?

What did we want to find out?

What did we do?

What did we find?

What are the limitations of the evidence?

How up to date is this evidence?

This evidence is up to date to 11 January 2023.

Licensed to CECÍLIA RODRIGUES ROSA - ceciliagyn@hotmail.com

Cochrane Database of Systematic Reviews

Licensed to CECÍLIA RODRIGUES ROSA - ceciliagyn@hotmail.com

Cochrane Database of Systematic Reviews

Licensed to CECÍLIA RODRIGUES ROSA - ceciliagyn@hotmail.com

BACKGROUND functional impairments, the use of a walking aid, a history of falls,

Trials were excluded when: Trials were excluded when they:

Figure 1. Study flow diagram.

8060 records 1 additional record

4938 records after

4938 records 4866 records

Blinding of participants and personnel (performance bias): All outcomes

Selective reporting (reporting bias)

Random sequence generation (selection bias)

0% 25% 50% 75% 100%

Low risk of bias Unclear risk of bias High risk of bias

Allocation concealment Incomplete outcome data

Sustainability of fear of falling effects more than six months'

data to assign individual patients to a specific intervention. The AUTHORS' CONCLUSIONS

despite comparable prevalence of falls (Pohl 2015), as well as ACKNOWLEDGEMENTS

NCT01268657 {published data only} Wolfe 2018 {published data only}

* NCT01268657. Intervention for anxiety after falls. References to ongoing studies

Suttanon 2018 {published data only}

Ayoubi 2014 Chua 2019

Delbaere 2010 Forstmeier 2015

Denkinger 2010 Franceschini 2023

Denkinger 2015 Fugl-Meyer 1991

Ehlers 2005 GRADEpro GDT [Computer program]

Lamb 2005 adults. Journals of Gerontology: Series B 2005;60(1):P34-40.

Montero-Odasso 2022 Pohl 2015

Moore 2008 Powell 1995

Murphy 1982 Review Manager 2014 [Computer program]

Characteristics of included studies [ordered by study ID]

Methods 3-arm RCT

Randomisation performed by an independent statistician who transferred the sequences to consecu-

Participants Country: Sweden

n = 175, at-home sessions

Mean age (years): 83 (SD 4.7)

Interventions CBT with exercise

Arm 1: OEP (n = 61): a series of 17 strength and balance exercises

Arm 3: control (n = 56): standard care. No treatment, only surveillance.

No conflicts of interest declared.

Protocol published in 2014. Intermediary results published in 2017.

Bias Authors' judgement Support for judgement