Received: 27 April 2019 Revised: 26 September 2019 Accepted: 13 October 2019

DOI: 10.1002/pon.5267

PAPER

Randomised controlled trial of internet‐delivered cognitive

behaviour therapy for clinical depression and/or anxiety in
cancer survivors (iCanADAPT Early)

M.J. Murphy1 | J.M. Newby1,2 | P. Butow3 | S.A. Loughnan1 | A.E. Joubert1 |

L. Kirsten3,4 | K. Allison3 | J. Shaw3 | H.L. Shepherd3 | J. Smith1 | G. Andrews1

1
Clinical Research Unit for Anxiety and
Depression, UNSW, NSW, Australia Abstract
2
School of PsychologyFaculty of Science, Purpose: To evaluate internet‐delivered cognitive behavioural therapy (iCBT) on
UNSW, NSW, Australia
3
clinical depression and/or anxiety, distress, fear of cancer recurrence, and quality of
Psycho‐oncology Co‐operative Research
Group, University of Sydney, NSW, Australia life in cancer survivors.
4
Nepean Cancer Care Centre, NSW, Australia Methods: Random assignation of 114 participants to iCBT or treatment‐as‐usual

Correspondence
(TAU). The clinician‐supervised iCBT program (iCanADAPT Early) consisted of eight
Murphy, M.J., Clinical Research Unit for lessons over 16 weeks. Self‐report questionnaires occurred at baseline, midpoint,
Anxiety and Depression UNSW NSW 2010,
Australia.
and posttreatment for both groups with 3‐month follow‐up for iCBT participants. A
Email: michael.murphy@unsw.edu.au mixed modelling approach to compare groups occurred.

Funding information Results: iCBT was superior to TAU on all outcome measures at posttreatment.
Cancer Institute NSW, Grant/Award Number: Compared with TAU, the iCBT group showed a significant decrease over time in anx-
14/TPG/1‐02
iety and depression symptoms (primary outcome, Hospital Anxiety and Depression
Scale, Hedges g = 1.51). Additionally the iCBT group had significantly lower general
distress (Kessler‐10, g = 1.56), fear of cancer recurrence (Fear of Cancer Recurrence
Inventory, g = 0.39), and significantly higher quality of life (Functional Assessment
of Cancer Therapy—General, g = 0.74) at posttreatment compared with the TAU
group. High adherence and satisfaction were found for iCBT with low clinician time.
Conclusion: Clinician‐supervised iCBT has significant benefits for cancer survivors
with clinical depression and anxiety disorders.

K E YW O RD S

anxiety, cancer, depression, Internet cognitive behavioural therapy, oncology, randomised

controlled trial

1 | IN T R O DU C T ION development of online interventions.3 Online therapies, primarily

Cancer survivors report high rates of anxiety (17.9%) and depressive
1
(11.6%) disorders which cause substantial morbidity, increased phys-
2
ical complications, and distress including suicidal ideation.
patients do not currently access evidence‐based psychological
and/or pharmacological treatments; hence, authors have identified a
need for newer approaches to psychosocial care including the
cognitive‐behavioural (iCBT), are acceptable and effective, achieving
comparable outcomes to face‐to‐face CBT for mild to severe anxiety
and depression in the general population.4 If found effective and
Many acceptable in the cancer context, iCBT may provide access to
standardised, evidence‐based therapy without physical and/or geo-
graphical barriers.5 Furthermore, as identified by Aaronson et al, “Rel-
atively low cost interventions with self‐management and e‐Health

76 © 2019 John Wiley & Sons, Ltd. wileyonlinelibrary.com/journal/pon Psycho‐Oncology. 2020;29:76–85.

MURPHY ET AL.
elements may be appropriate for the majority of survivors, with
resource intensive interventions being reserved for those most in
need”6 meaning that those populations most in need of face‐to‐face
therapy may receive it, such as the elderly and culturally and linguisti-
cally diverse patients.
Evaluation of online interventions in cancer survivors with clinical
depression and/or anxiety has begun, with feasibility studies showing
7 7,8
preliminary efficacy and acceptability. This trial is novel as it is
the first randomised controlled trial (RCT) of an online intervention
(iCBT or other psychotherapies) for clinical depression and/or anxiety
disorders in cancer survivors, with the aim of determining the efficacy
of this cancer‐specific iCBT intervention. We hypothesised that iCBT
plus treatment‐as‐usual (TAU) would produce clinically relevant
decreases in depressive and anxious symptoms as shown by a
decrease in the total Hospital and Anxiety Depression Scale (HADS‐
T) score (primary outcome measure) compared with a control group
receiving only TAU. We further hypothesised that iCBT would pro-
duce clinically relevant decreases in general distress and fear of cancer
recurrence and improve physical, social, and emotional functioning.
2 | PATIENTS AND METHODS
2.1 | Participants
Inclusion eligibility criteria at the time of enrolment were oncological—
early stage cancer (cancer treatment, and/or posttreatment(s), with
curative intent), cancer diagnosis >6 weeks prior; psychological—a
HADS‐Total score of ≥6 (identifying 95% of cases 9,10
), met diagnostic
criteria for ≥1 DSM‐5 disorder including Major Depressive Disorder,
Generalised Anxiety Disorder, Illness Anxiety Disorder, Panic Disorder,
Agoraphobia, and/or Adjustment Disorder according to the Anxiety
11
Disorders Interview Schedule for DSM‐5 (ADIS‐5 ) administered by
MM [psychiatrist], had no active suicidality; general—adult [≥18 years],
fluent English, Australian resident, had access to computer/printer,
provision of own name, phone number and address, and their general
practitioner's details.
Exclusion criteria at the time of enrolment were oncological—
hospitalised, self‐report of metastases, primary brain cancer (due to
potential cognitive changes), Eastern Cooperative Oncology Group
(ECOG) performance status of ≥2; psychological—active alcohol misuse
(Alcohol Use Disorders Identification Test Consumption [AUDIT‐C]
and clinical interview), were undergoing recent/current CBT, had a
current/past diagnosis of schizophrenia or bipolar disorder, were tak-
ing antipsychotic medications, and had frequent suicidality (indicated
by ≥2 to item‐9; Beck Depression Inventory‐II).
2.2 | Design and procedures
A randomised controlled superiority trial with parallel arms using a 1:1
allocation ratio comparing Intervention Arm against Comparator Arm.
Randomisation numbers were generated by an independent
researcher using www.random.org, and placed in concealed, opaque
77
envelopes, which were opened by the interviewer at completion of
the diagnostic interview.
In 2016, applicants self‐referred to a website (www.virtualclinic.
org.au), where they completed an online screening questionnaire com-
posed of inclusion and exclusion criteria and a HADS‐Total. Applicants
who met eligibility criteria and scored ≥6 on the HADS‐Total
proceeded to telephone interview assessment where if successful they
completed an electronic informed consent.
2.3 | Treatment
Please refer to the online supplemental material “Supplement 1” which
details all aspects of the iCBT intervention, presents an overview of
the lessons (eight lessons over 16 weeks), describes the running of
the trial, and outlines the frequency of clinician contact.
2.3.1 | Intervention arm (iCBT group)
The iCBT program, named “iCanADAPT Early” consisted of an online
self‐managed but clinician supervised, 16‐week, eight‐lesson program
with general and cancer‐specific cognitive‐behavioural (CBT) skills. It
was adapted from a proven transdiagnostic program.11 There are four
components: (a) The compulsory “lesson” ie, content, presented in sim-
plified comic form (low literacy requirement); (b) A noncompulsory
supplementary extra resources section post lesson (moderate literacy
requirement); (c) A downloadable “lesson summary” outlining the
CBT practice and homework exercises; and (d) an audio‐visual compo-
nent comprising of an introductory short video and two CDs (one
outlined relaxation strategies, the other basic mindfulness practices).
The iCBT group were also allowed to access their family doctor
and/or local (mental) health services as required (similar to the TAU
group).
2.3.2 | Comparator arm (TAU group)
Participants could access their family doctor and/or local (mental)
health services.
2.4 | Assessments
The main assessment tools are validated in cancer survivors. Both
groups completed the same measures three times, pretreatment (base-
line, postrandomisation), midpoint, and posttreatment. The iCBT par-
ticipants additionally completed a Kessler‐10 Psychological Distress
Scale (K‐10) before each lesson and completed all meaures at 3‐month
follow‐up.
Primary outcome: The Hospital Anxiety and Depression Scale
(HADS)9; used to self‐report depression (HADS‐Depression subscale)
and anxiety (HADS‐Anxiety subscale). Each subscale has seven ques-
tions (scoring from 0 to 3, max 21). Subscale total scores of 0 to 7
are normal, 8 to 10 borderline abnormal/case, and 11 to 21 abnormal
(case).
78
2.4.1 | Secondary outcome measures
Kessler‐10 Psychological Distress Scale (K‐10)12: 10 items on a five‐
point scale to measure nonspecific psychological distress. High scores
indicate higher distress.
Fear of Cancer Recurrence Inventory (FCRI)13: 42 items (seven
subscales) assessing worry of cancer returning. High scores indicate
greater fear.
Functional Assessment of Cancer Therapy—General (FACT‐G, ver-
sion 4)14: 33 items (four subscales) assessing general cancer quality of
life. High scores indicate better quality of life.
Credibility and Expectancy/Satisfaction Questionnaire15: scale for
measuring treatment expectancy and credibility.
Other secondary measures outlined in the protocol paper are not
presented. Items such as Item 9 of the Beck Depression Inventory,
second‐edition (BDI‐II, Item 9)16 and the Patient Health Questionnaire
9‐item scale, Question‐9 (PHQ9‐Q9) 17
are each single stems and were
administered for trial risk monitoring to assess the presence and sever-
ity of suicidal ideation/suicide risk.
2.5 | Sample size
A sample size of 44 per group was calculated to detect a 0.6 effect size
for iCBT to improve more than TAU (power at 80%, alpha set at 0.05).
No research exists for iCBT in clinical range depression and/or anxiety
in cancer patients; hence, assumptions on the effect size were extrap-
olated from data on a trans‐diagnostic iCBT intervention in community
noncancer samples. 18,19
Target accrual was 100 participants to
address attrition.
2.6 | Statistical analysis
Significance testing of group differences regarding demographic data
and pretreatment measurements was conducted using cross‐
tabulations, independent t‐tests, analysis of variance (ANOVA), and
χ2 for categorical data, with differences in baseline outcome measures
controlled for in further analyses.
Intent‐to‐treat (ITT) mixed models using restricted maximum likeli-
hood (REML) estimation was used to account for missing data due to
participant drop‐out. Mixed models were estimated separately for
each outcome variable, with time, treatment group, and time‐by‐group
interaction entered as fixed factors. Mixed models do not assume that
the last measurement is stable (the last observation carried forward
assumption).20 REML models were deemed appropriate as it has mul-
tiple time points.21 The assumption that data were missing at random
(MAR) was evaluated using binary logistic regression to predict drop‐
out (0 = no drop‐out, 1 = drop‐out) and by comparing the two groups
on baseline measures. Significant effects were followed up with
pairwise contrasts comparing mean pretreatment to mean posttreat-
ment scores. Between‐group effect sizes were calculated using the
pooled standard deviation of the estimated marginal means and
adjusted for sample size (Hedges g). Effect sizes are considered 0.20
small, 0.50 moderate, and 0.80 large.22
MURPHY ET AL.
As outlined in the published protocol paper,23 we had planned to
stratify results according to cancer treatment status and compare out-
comes for those in “active treatment” versus those who had completed
their primary cancer treatment. However, the sample size of partici-
pants in active treatment was too small for results to be meaningful.
3 | R ES U LT S
3.1 | Participant flow
See “Figure 1.” 324 people commenced online screening, and 184(57%)
of them proceeded to the telephone interview; 114(62%) of the 184
people were found eligible and were randomised: 53(46%) participants
to iCBT and 61(54%) participants to TAU. One participant was lost to
follow‐up in both groups before baseline questionnaire completion.
Adherence was high; for iCBT, 40/52(77%) participants completed
eight lessons, with 48(92%) participants completing posttreatment
questionnaires and 41(79%) completing the 3‐month follow‐up assess-
ment. In the TAU group, 56/60(93%) participants completed the
postassessment. No serious related adverse events were reported.
3.2 | Demographics, clinical characteristics, and
baseline measures
See “Table 1.” There were no significant group differences on demo-
graphic or clinical characteristics, including cancer and mental health
variables; 67% (76 participants) had breast cancer. The average num-
ber of mental health diagnoses was 1.8(range 1‐5, SD = 0.99).
A significance between group difference (P = .045) was noted with
baseline HADS‐Total (iCBT = 21.87 [SD = 5.32] versus TAU = 19.68
[SD = 5.97]). The between group difference was via HADS‐Anxiety dif-
ferences (P < .017); HADS‐Depression was not statistically different (P
< .29). After adjusting for HADS‐Total, there were no other significant
baseline psychological differences between groups. HADS‐Total
scores were entered as a covariate for the remaining analyses. Internal
reliabilities for the current sample were acceptable (Cronbach's α:
HADS‐Total = 0.82; K‐10 = 0.81; FACT‐Total = 0.89; FCRI‐Total =
0.90).
3.3 | Pretreatment to posttreatment outcome
measures and effect sizes
“Table 2” presents baseline and posttreatment estimated marginal
means and effect sizes for each total outcome measure (linear mixed
model analyses adjusted to control baseline HADS‐T) and the HADS
subscales. Online supplemental material Supplement 2 presents all total
and subscales outcome measures.
3.3.1 | Primary outcomes
There were significant group‐by‐time interactions for overall HADS‐
Total ( F (3, 141.4) = 364.1, P < .01), and HADS‐Anxiety ( F (3, 108.6)
MURPHY ET AL.
= 176.7, P < .01) and HADS‐Depression ( F (3, 109.8) = 310.4, P < .01).
Between‐group effect sizes were large for HADS‐Total (g = 1.51),
HADS‐Anxiety (g = 0.90), and HADS‐Depression (g = 1.08). In iCBT,
there was a large and significant within‐group reduction between pre-
treatment and posttreatment for HADS‐Total (g = 1.64), with similar
large and significant within‐group reductions for both subscales
(HADS‐Anxiety g = 1.54; HADS‐Depression g = 1.26,). In TAU, signifi-
cant but small reductions were found for HADS‐Anxiety only (g =
0.40).
3.3.2 | Secondary outcomes
Significant group‐by‐time interactions for all secondary outcome mea-
sures total scores occurred. The between‐group effect sizes were large
79
FIGURE 1 CONSORT diagram
for distress (K‐10, g = 1.56), small for fear of recurrence (FCRI‐Total, g
= 0.39, with subscale variation), and moderate for quality of life (FACT‐
G‐Total, g = 0.74, with three of the four subscales having similar
Hedges g).
For iCBT, there was a large and significant within‐group reduction
for total scores on each secondary measure (K‐10, g = 1.76; FCRI‐
Total, g = 1.09; FACT‐G‐Total, g = 0.91). In the within‐group analysis
of iCBT, five of the FCRI‐subscales showed significance increases, with
FCRI‐Coping Strategy showing a significant decrease. iCBT FACT‐G‐
subscales showed significant medium to large improvements in quality
of life except for FACT‐G‐Social/Family well‐being.
For secondary measures in TAU, significant but small reductions
were only found for FCRI‐Total (g = 0.20). This was driven through
two of the FCRI‐subscales (Severity and Functioning Impairment).
80 MURPHY ET AL.

TABLE 1 Demographic, clinical characteristics, and baseline measures

Total TAU iCBT

n = 114 % n = 61 % n = 53 % X2 p

Demographics
Sex
Female 101 89 55 90 46 87 X2 (1) = .32 0.57
Male 13 11 6 10 7 13
Marital status
Married/de‐facto 73 64 40 66 33 62 X2 (2) = .74 0.69
Single/never married 21 18 12 20 9 17
Separated/widowed 20 18 9 15 11 21
Education
High school/certificate 62 54 31 51 31 59 X2 (1) = .673 0.412
≥ University degree 52 46 30 49 22 42
Employment status
Full‐time work 31 27 13 21 18 34 X2 (6) = 10.68 0.099
Part‐time work 40 35 22 36 18 34
Unemployed 12 11 6 10 6 11
Student 3 3 0 0 3 6
At home parent 3 3 3 5 0 0
Retired 19 17 12 20 7 13
Disability support 6 5 5 8 1 2
Country of birth
Australia 91 80 48 79 43 81 X2 (1) = .105 0.746
Other 23 20 13 21 10 19
Living rural area 24 21 13 21 11 21 X2 (1) = .005 0.942
Have children 85 75 44 72 41 77 X2 (1) = .409 0.523
Heard about trial
Facebook/online 48 42 24 39 24 45 X2 (3) = .667 0.881
Word of mouth 24 21 13 21 11 21
Cancer database 34 30 20 33 14 26
Local recruitment 8 7 4 7 4 8
Age, years
Mean 53.29 53.30 53.28 t(112) = .007 0.575
SD 9.65 10.09 9.22
Cancer factors
Time since cancer diagnosis
Mean, years 3.88 3.86 3.91 t(112) = .063 0.606
SD 4.13 4.43 3.81
< 1 year 27 24 18 30 9 17 X2 (2) = 2.741 0.254
1‐5 years 55 48 26 43 29 55
> 5 years 32 28 17 28 15 28
Primary cancer
Breast 76 67 43 71 33 62 X2 (6) = 1.706 0.945
Prostate 6 5 2 3 4 8

(Continues)
MURPHY ET AL. 81

TABLE 1 (Continued)

Total TAU iCBT

n = 114 % n = 61 % n = 53 % X2 p
Gynaecological 6 5 3 5 3 6
Lymphoma 5 4 3 5 2 4
Bowel 4 4 2 3 2 4
Melanoma 4 4 2 3 2 4
Other 13 11 6 10 7 13
Breast vs non‐breast cancer
Breast 76 67 43 70 33 62 X2 (1) = .864 0.353
Non‐breast 38 33 18 30 20 38
Cancer treatments
Surgery 102 90 56 92 46 87 X2 (1) = .756 0.385
Chemotherapy 67 59 38 62 29 55 X2 (1) = .672 0.412
Radiotherapy 63 55 30 49 33 62 X2 (1) = 1.964 0.161
Hormonal therapy 45 40 23 38 22 42 X2 (1) = .172 0.679
Mental health factors
DSM diagnosis
Major depressive disorder 63 55 37 61 26 49 X2 (1) = 1.543 0.214
Generalised anxiety disorder 69 61 36 59 33 62 X2 (1) = .125 0.723
Illness anxiety disorder 60 53 30 49 30 57 X2 (1) = .627 0.429
Panic disorder 10 9 3 5 7 13 X2 (1) = 2.435 0.119
Agoraphobia 12 11 4 7 8 15 X2 (1) = 2.195 0.139
Adjustment disorder 4 4 3 5 1 2 X2 (1) = .770 0.38
Depression/anxiety before cancer (self‐report) 65 57 36 59 29 55 X2 (1) = .214 0.644
Treatments
Antidepressant meds 45 40 26 43 19 36 X2 (1) = .545 0.461
Non‐CBT therapy 60 53 36 59 24 45 X2 (1) = 2.145 0.143

Total TAU iCBT

Baseline measures (pre) M SD M SD M SD t p

HADS‐Total 20.70 5.75 19.68 5.97 21.87 5.32 2.029 0.045*

Anxiety 11.83 3.18 11.17 3.37 12.6 2.79 2.425 0.017***
Depression 8.87 3.74 8.52 3.77 9.27 3.72 1.061 0.291
K‐10 26.89 5.63 26.35 5.88 27.52 5.3 1.098 0.275
FCRI‐Total 88.68 19.12 84.98 20.27 92.94 16.91 2.236 0.027*
Triggers 19.84 5.12 18.6 5.27 21.27 4.58 2.839 0.005***
Severity 22.43 5.70 21.75 6.01 23.21 5.26 1.359 0.177
Psychological distress 8.28 3.57 7.62 3.43 9.04 3.62 2.134 0.035**
Functioning impairment 9.74 5.72 8.82 5.63 10.81 5.69 1.857 0.066
Insight 3.51 2.69 2.92 2.75 4.19 2.47 2.564 0.012**
Reassurance 3.18 2.31 3.07 2.2 3.31 2.43 0.550 0.584
Coping strategies 21.70 4.94 22.22 4.89 21.12 4.98 −1.178 0.241
FACT‐G‐Total* 60.60 15.75 62.28 16.69 58.65 14.51 −1.219 0.226
Physical well‐being* 18.28 5.68 17.97 5.82 18.63 5.55 0.619 0.537

(Continues)
82 MURPHY ET AL.

TABLE 1 (Continued)

Total TAU iCBT

Baseline measures (pre) M SD M SD M SD t p
Social/Family well‐being* 15.22 6.19 16.07 6.35 14.25 5.92 −1.559 0.122
Emotional well‐being* 13.16 4.21 13.47 4.16 12.81 4.29 −0.824 0.412
Functional well‐being* 13.94 5.17 14.78 5.36 12.96 4.81 −1.882 0.063

M = mean; SD = standard deviation; df of 110 for all values; *positive scales

*positive scales
HADS—Hospital Anxiety and Depression Scale;
K‐10—Kessler‐10 Psychological Distress Scale;
FCRI—Fear of Cancer Recurrence Inventory;
FACT‐G—Functional Assessment of Cancer Therapy—General

TABLE 2 Outcome measure changes from baseline (pre) to posttreatment

Pretreatment Posttreatment Pre‐posttreatment within‐group ES Post between‐group ES

EMM SD EMM SD t P value r g (95%CI) g (Hedges′) (95%CI)

HADS‐Total
iCBT 20.79 3.81 12.57 3.73 11.47 0.000 0.51 1.64 (1.18, 2.09) 1.51 (1.07, 1.95)
TAU 20.45 3.76 18.26 3.73 3.31 0.003 0.73 0.32 (−0.04, 0.69)
HADS‐Anxiety
iCBT 12.03 1.98 7.61 2.83 11.08 0.000 0.54 1.54 (1.10, 1.98) 0.90 (0.50, 1.31)
TAU 11.54 1.94 10.19 2.83 3.64 0.001 0.67 0.40 (0.03, 0.76)
HADS‐Depression
iCBT 8.64 1.99 4.88 3.02 8.52 0.000 0.47 1.26 (0.84, 1.69) 1.08 (0.67, 1.50)
TAU 8.99 1.95 8.18 3.02 1.99 0.148 0.77 0.18 (−0.18, 0.54)
K‐10
iCBT 26.62 3.90 18.36 4.92 11.85 0.000 0.47 1.76 (1.30, 2.22) 1.56 (1.12, 2.00)
TAU 26.99 3.83 26.08 4.91 1.42 0.645 0.76 0.13 (−0.23, .049)
FCRI‐Total
iCBT 91.48 18.53 73.80 19.31 9.45 0.000 0.68 1.09 (1.46, 2.40) 0.39 (0.00, 0.78)
TAU 85.84 18.23 81.33 19.20 2.61 0.031 0.83 0.20 (0.12, 0.86)
FACT‐G‐Total*
iCBT 61.03 11.44 74.61 14.29 −9.47 0.000 0.78 −0.91 (−1.32, −0.50) 0.74 (0.34, 1.13)
TAU 60.50 11.26 64.06 14.21 −2.68 0.025 0.85 −0.20 (−0.56, 0.16)

*positive scales

3.4 | Pretreatment to 3‐month follow‐up (3MFU)
outcome measures and effect sizes
Table 3 presents iCBT with the unadjusted pretreatment (baseline),
posttreatment, and 3MFU linear mixed models, and the within‐group
effect sizes for each outcome measure. There were large and statisti-
cally significant effect sizes for Total scores on each of the outcome
measures from pre to 3MFU for iCBT group. There were no statisti-
cally significant differences for the iCBT group on any outcome mea-
sures between posttreatment and 3MFU. There is no TAU 3MFU
data as they were then offered the chance to undertake the iCBT
intervention. Online supplemental material Supplement 3 presents all
total and subscales outcome measures.
3.5 | Additional results
3.5.1 | Treatment satisfaction and confidence rates
At posttreatment, the majority of iCBT participants rated positive sat-
isfaction (n = 38/46; 83%) on the Treatment Credibility/Expectancy
MURPHY ET AL. 83

TABLE 3 Outcome measure changes from baseline (pre) to 3‐month follow‐up

Pretreatment Posttreatment 3MFU Pre‐3MFU treatment within‐group ES

EMM SD EMM SD EMM SD t P r g (95%CI)

HADS‐Total 21.90 5.36 13.69 6.409 13.71 5.70 9.68 0.000 0.56 1.43 (0.97, 1.89)
Anxiety 12.57 2.81 8.14 3.374 8.25 3.19 9.67 0.000 0.56 1.42 (0.96, 1.88)
Depression 9.33 3.72 5.50 3.54 5.41 3.07 7.05 0.000 0.47 1.13 (0.69, 1.58)
K‐10 27.55 5.36 19.19 5.335 19.74 5.39 10.33 0.000 0.59 1.47 (1.01, 1.93)
FCRI‐Total 92.73 17.00 75.01 17.36 74.91 16.75 8.27 0.000 0.65 1.08 (0.64, 1.52)
FACT‐G‐Total* 58.45 14.58 72.07 16.69 70.54 16.18 −8.66 0.000 0.84 −0.76 (−1.18, −0.33)

*positive scales

Questionnaire rating scale with 40%(n = 17) indicating they were
“Very satisfied” and 46%(n = 21) “Mostly satisfied.” When iCBT partic-
ipants were asked to rate their confidence in “recommending the pro-
gram to a friend experiencing similar problems,” 57%(n = 26) rated
themselves “Very confident” and 28%(n = 13) “Confident.”
person has less fear of cancer recurrence; hence, the increase may be
a positive finding. The large improvements in quality of life achieved
only in the iCBT group are likely an accumulation of the benefits
realised via skills targeting depression, general anxiety, distress, and
fear of cancer recurrence.

3.5.2 | Clinician time spent contacting participants 4.1 | Study limitations

There was a significant difference (P < .0001) between clinician time The clinical characteristics of the participants are similar to that
spent per group; average 64.3 minutes (SD = 40) per iCBT participant reported in many studies in the area of cancer survivor research (ie,

on email and telephone contact versus 17.6 minutes (SD = 12) per
TAU participant.
4 | DISCUSSION
This is the first RCT to evaluate internet‐delivered cognitive behav-
ioural therapy (iCBT) for clinical depression and/or anxiety disorders
in cancer survivors. Participants in the iCBT group showed significant
improvements in depression, anxiety, distress, fear of cancer recur-
rence, and quality of life. The iCBT group was superior to TAU on all
outcomes at posttreatment. These results were achieved with minimal
clinician contact, and the effects were sustained at 3‐month follow‐up.
The participants had high morbidity, meeting criteria for a diagnos-
able anxiety and/or depressive disorder by both clinical diagnostic
interview and high initial HADS‐scores (similar to other clinical range
24
survivor cohorts ). The participants also had high rates of psychiatric
comorbidity, indicating higher severity of impairment.25
transdiagnostic treatment approach was warranted given the average
participant met criteria for two clinical disorders.
The course completion rate was higher than iCBT completion rates
reported in a meta‐analysis and approached rates found for face‐to‐
face CBT.26 Changes in the secondary measures may have occurred
in response to CBT skills which addressed general depression and/or
anxiety symptoms, or may have occurred in response to CBT skills
which specifically addressed aspects of cancer‐related distress and
27
fear of cancer recurrence. In line with other researchers,
hypothesise that the FCRI subscale Coping Strategies, in contrast to
the five other subscales, increased because some of the stems, eg, “I
pray, meditate or do relaxation” may actually score higher when a
predominantly middle‐aged woman with breast cancer who are 1 to
5 years postdiagnosis). While this may limit its generalisability to other
demographics and cancer types, this overrepresentation is typical in
psycho‐oncology research and is in part due to high numbers of breast
cancer survivors and a greater proportion of women engaging with
psychological services more generally. Follow‐up of the iCBT group
ceased at 3‐months posttreatment. Prior findings28 reported that “indi-
vidual CBT has short‐term effects [<8 months]” on both depression and
anxiety; hence, studies of iCBT for cancer patients over a longer
follow‐up period are needed to establish long‐term benefits. Addition-
ally, this study did not address efficacy in those living with advanced
cancer. On the advice of consumers elicited during focus groups,8
the intervention, and its associated tailored CBT skills, were specifi-
cally designed for early stage cancer survivors with clinical range psy-
chological disorders, who have specific needs. Furthermore, this
participant group self‐referred to the study and iCBT program and
were excluded if they had any significant comorbidities (such as prob-
A lem drug and alcohol use).
4.2 | Clinical implications
In this RCT iCanADAPT Early demonstrated feasibility and preliminary
efficacy. In future effectiveness trials, it could be further evaluated
under clinician‐guidance (as presented), in a stepped‐care model,29 or
it could supplement face‐to‐face therapy (“blended therapy”30). These
models of care may add acceptability and increase engagement31
we which will ultimately add to their sustainability. Authors have called
for the development of “low cost, simple, specific, and effective (psycho-
logical) treatments” as a way to increase access worldwide to interven-
tions.32 iCBT can become such an intervention for cancer survivors
84
with clinical depression and anxiety, increasing access while potentially
decreasing health care costs.33
5 | CONCLUSION
Clinician supervised iCBT shows preliminary efficacy for treating clini-
cal anxiety and/or depressive disorders in cancer survivors. The find-
ings from this study indicate that participants are satisfied with the
mode of treatment. Given the scalability of iCBT, it has the potential
to reduce the emotional health burden of the increasing numbers of
cancer survivors.
ACKN O WLE DGM EN TS
This iCBT Program, iCanADAPT Early, was developed as part of the
Anxiety and Depression Pathway (ADAPT) Program, led by the
Psycho‐oncology Cooperative Research Group (PoCoG). The ADAPT
Program was supported by a Cancer Institute NSW competitive grant.
Dr Murphy was supported by a 2016 NSW Institute of Psychiatry
Research Fellowship. Dr Newby is supported by a Medical Research
Future Fund Career Development Fellowship. Prof Butow is supported
by an NHMRC Senior Principal Research Fellowship. This research was
supported by Register4 through its members' participation in research
and/or provision of samples and information. The authors would addi-
tionally like to acknowledge the commitment and contribution to this
study of Dr Melanie Price (1965‐2018). Dr Price was a respected
member of the psycho‐oncology and palliative care community in Aus-
tralia for over 22 years. She was a tireless advocate for people affected
by cancer, their families, and psycho‐oncology as a discipline.
CONFLICT OF INTE REST
The authors declare no conflicts of interest.
F U ND I N G
This study was funded by a Cancer Institute NSW Translational Pro-
gram Grant (grant number 14/TPG/1 to 02 awarded to recipient Pro-
fessor Phyllis Butow).
DISCLA IMER
The views expressed herein are those of the authors and are not nec-
essarily those of the Cancer Institute NSW.
COMPLIANCE WIT H E THICAL ST ANDARDS
All procedures performed in studies involving human participants were
in accordance with the ethical standards of the institutional and/or
national research committee and with the 1964 Helsinki declaration
and its later amendments or comparable ethical standards. Ethical
approval was obtained via the National Human Research Ethics Com-
mittees (HREC), Australia (HREC/15/SVH/432). The trial was regis-
tered on the Australian New Zealand Clinical Trials Registry:
ACTRN12616000231448 (www.anzctr.org.au). Informed consent
was obtained from all individual participants included in the study.
MURPHY ET AL.
DA TA AVAILABILITY STATEMENT
The data that support the findings of this study are available on
request from the corresponding author. The data are not publicly avail-
able due to privacy and ethical restrictions.
ORCI D
M.J. Murphy https://orcid.org/0000-0001-8963-5747
P. Butow https://orcid.org/0000-0003-3562-6954
J. Shaw https://orcid.org/0000-0002-9543-7066
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S UP P O R T I N G I N F O R M A T I ON
Additional supporting information may be found online in the
Supporting Information section at the end of the article.
How to cite this article: Murphy MJ, Newby JM, Butow P,
et al. Randomised controlled trial of internet‐delivered cogni-
tive behaviour therapy for clinical depression and/or anxiety
in cancer survivors (iCanADAPT Early). Psycho‐Oncology.
2020;29:76–85. https://doi.org/10.1002/pon.5267