898528 ANP ANZJP ArticlesGreen et al.

Research

Australian & New Zealand Journal of Psychiatry

Cognitive behavioral therapy for 1­–10

https://doi.org/10.1177/0004867419898528
DOI: 10.1177/0004867419898528

perinatal anxiety: A randomized © The Royal Australian and

New Zealand College of Psychiatrists 2020

controlled trial Article reuse guidelines:

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Sheryl M Green1,2, Eleanor Donegan1,2 , Randi E McCabe1,3,

David L Streiner1, Arela Agako2 and Benicio N Frey1,2,4

Abstract
Background: Up to one in five women meet diagnostic criteria for an anxiety disorder during the perinatal period (i.e.
pregnancy and up to 1 year postpartum). While psychotropic medications are effective, they are associated with risks
for mothers and babies. There is a growing demand for evidence-based non-pharmacological treatments for perinatal
anxiety.
Objective: To evaluate the effectiveness of a cognitive behavioral group therapy protocol for perinatal anxiety.
Methods: In total, 96 women were randomized to cognitive behavioral group therapy or waitlist at a clinic specializing
in women’s mental health. Participants were 22–41 years of age, pregnant or up to 6 months postpartum and had an
anxiety disorder with or without comorbid depression.
Results: Compared to waitlist, participants in cognitive behavioral group therapy reported significantly greater reduc-
tions in the primary outcome of anxiety (State-Trait Inventory of Cognitive and Somatic Anxiety, η2p = .19; Hamilton
Anxiety Rating Scale, η2p = .16), as well as in secondary outcomes including worry (Penn State Worry Questionnaire,
η2p = .29), perceived stress (Perceived Stress Scale, η2p = .33) and depressive symptoms (Edinburgh Postnatal Depression
Scale, η2p = .27; Montgomery–Åsberg Depression Rating Scale, η2p = .11). Maternal status (pregnant, postpartum) and
medication use were unrelated to treatment outcomes. All gains were maintained, or continued to improve, at 3-month
follow-up.
Conclusion: Cognitive behavioral group therapy was effective in improving anxiety and related symptoms among
women with anxiety disorders in the perinatal period.

Keywords
Perinatal period, anxiety, depression, cognitive behavioral therapy, randomized controlled trial

The perinatal period is a time of vulnerability for mental

health problems in women (Dennis et al., 2017; Giardinelli 1
 epartment of Psychiatry and Behavioural Neurosciences, McMaster
D
et al., 2012; Wenzel et al., 2005). Most research has focused University, Hamilton, ON, Canada
2
on postpartum depression, which affects 13–19% of women Women’s Health Concerns Clinic, St. Joseph’s Healthcare Hamilton,
in the first year after delivery (O’Hara and McCabe, 2013). Hamilton, ON, Canada
3
Anxiety Treatment and Research Clinic, St. Joseph’s Healthcare
Anxiety disorders during the perinatal period are now Hamilton, Hamilton, ON, Canada
known, however, to be at least as common, affecting up to 4
Mood Disorders Program, St. Joseph’s Healthcare Hamilton, Hamilton,
15% of women in pregnancy and up to 20% postpartum ON, Canada
(Goodman et al., 2016; Grant et al., 2008). Despite their
Corresponding author:
high prevalence, anxiety disorders in the perinatal period
Sheryl M. Green, Women’s Health Concerns Clinic, St. Joseph’s
have received considerably less research and clinical atten- Healthcare Hamilton, 100 West 5th Street, Hamilton, ON L8N 3K7,
tion. This is problematic given the substantial adverse Canada.
impact anxiety disorders can have on mothers and their Email: sgreen@stjoes.ca

Australian & New Zealand Journal of Psychiatry, 00(0)

2 ANZJP Articles
infants (e.g. more frequent obstetric complications, poor
neonatal and psychosocial outcomes, disruption in bonding
and increased healthcare costs; Alder et al., 2007; Andersson
et al., 2004; Banhidy et al., 2006; Bauer et al., 2016; Berle
et al., 2005; Grigoriadis et al., 2018; Putnam et al., 2017).
Anti-depressants are effective for anxiety and depres-
sion in pregnant and postpartum women (MacQueen et al.,
2016; Marchesi et al., 2016). However, some medications
have been associated with risks for the fetus and infant
(Grigoriadis et al., 2013; for example, poor neonatal adap-
tation syndrome, persistent pulmonary hypertension of the
newborn). Best practice guidelines in Canada (MacQueen
et al., 2016), Australia (Andrews et al., 2018), the United
States (American Psychiatric Association [APA], 2010)
and the United Kingdom (McAllister-Williams et al., 2017)
recommend non-pharmacological interventions as first-line
treatments for depression or anxiety during pregnancy and
the postpartum, while psychotropic medications are only
recommended for severe symptoms. Moreover, many
women prefer non-pharmacological interventions during
this period (Dennis and Chung-Lee, 2006). Empirically
supported non-pharmacological interventions are therefore
imperative for this population.
Cognitive behavioral therapy (CBT) is considered the
first-line psychological treatment for anxiety and depres-
sive disorders in the general population (McAllister-
Williams et al., 2017). Studies with non-perinatal samples
show that CBT is more effective than waitlist or placebo
conditions (Cohen’s d = 0.82–1.26) and, in at least some
studies, is more effective than other active interventions
(d = 0.69–1.20; Covin et al., 2006; Gould et al., 1997; Otto,
2005). Furthermore, gains can be maintained for at least
1 year following treatment for anxiety (DiMauro et al.,
2012) and depression (Wiles et al., 2016) and up to 8 years
following treatment for worry (Covin et al., 2006; Durham
et al., 2003).
A small number of studies have examined the effective-
ness of CBT for anxiety symptoms in pregnant or postpar-
tum women with evidence that CBT can be effective (see
Goodman et al., 2016; Maguire et al., 2018, for reviews). In
a recent meta-analysis, however, Maguire et al. (2018)
reported a small between-group effect size (Cohen’s
d = 0.49) across studies comparing CBT for perinatal anxi-
ety to control conditions. Moreover, considerable heteroge-
neity in effect sizes across studies was noted. These findings
are somewhat at odds with the strong empirical support for
CBT for anxiety disorders in the general population.
Moreover, several important limitations were identified,
including a reliance on open trials (e.g. Kim et al., 2014;
Lilliecreutz et al., 2009; Milgrom et al., 2015; Nieminen
et al., 2016), small samples (e.g. Green et al., 2015;
Karamoozian and Askarizadeh, 2015; Kim et al., 2014) and
a focus on a narrow range of anxiety symptoms and corre-
sponding interventions (e.g. Fathi-Ashtiani et al., 2015;
Karamoozian and Askarizadeh, 2015; Nieminen et al.,
Australian & New Zealand Journal of Psychiatry, 00(0)
2016). Given these limitations, the existing empirical sup-
port for non-pharmacological interventions for perinatal
anxiety must be considered preliminary at best (Goodman
et al., 2016; Maguire et al., 2018).
Our research team recently developed a new cognitive
behavioral group therapy (CBGT) protocol for perinatal
anxiety tailored to meet the unique needs of this population.
This protocol (Green et al., 2019) was developed to be
transdiagnostic to target any anxiety disorder (e.g. general-
ized anxiety disorder, social anxiety disorder), with or with-
out comorbid depression, to reach as many women as
possible. The protocol includes a range of cognitive and
behavioral interventions, all of which have empirical sup-
port in the non-perinatal literature. Furthermore, the con-
tent of our CBGT protocol targets common anxiety-related
beliefs, expectations, predictions and associated behaviors
that women report during pregnancy or postpartum and that
are likely to occur in the context of the significant life-
changing transitions and challenges encountered during
this period (e.g. changes in relationships, roles, responsi-
bilities, lifestyles). Finally, the protocol was designed as a
six-session treatment to make participation feasible for this
population. A single-sample pilot study provided initial
empirical support with significant reductions in anxiety
symptoms and depressive symptoms as well as high treat-
ment satisfaction (Green et al., 2015). The aim of this study
was to validate CBGT for perinatal anxiety in a randomized
controlled trial (RCT). We hypothesized that CBGT would
be associated with greater reductions in anxiety, as well as
secondary outcomes (i.e. worry, depressive symptoms per-
ceived stress), compared to a waitlist. Finally, we expected
that the benefits of CBGT would be maintained 3 months
post-treatment. Client satisfaction was also assessed.
Methods
A single-blind RCT (Clinicaltrials.gov ID NCT02850523)
was conducted between September 2016 and January 2019
at a university-affiliated teaching hospital clinic that spe-
cializes in assessment and treatment of women’s mental
health during reproductive milestones. The study protocol
was approved by the Hamilton Integrated Research Ethics
Board in Hamilton, Ontario. All participants provided writ-
ten informed consent before study entry.
Participants
An initial sample of 96 women was recruited from the regu-
lar clinic patient flow. Eligibility criteria were as follows:
(1) 18–45 years old; (2) pregnant or within the first 6 months
postpartum; (3) a principle diagnosis of an anxiety disorder
as per the Structured Clinical Interview for Diagnostic and
Statistical Manual of Mental Disorders (4th ed.; DSM-IV)
(First et al., 1994) with or without comorbid depression (all
diagnoses were checked against Diagnostic and Statistical
Green et al. 3
Figure 1.  Flowchart of participants.
Manual of Mental Disorders [5th ed.; DSM-5; APA, 2013]
diagnostic criteria and, where any discrepancies occurred,
DSM-5 criteria were followed); (4) not taking psychotropic
medication or, if taking medication, no change in dose and
type for a minimum of 6 weeks prior to baseline assess-
ment; (5) no changes in psychotropic medication during
6-week CBGT or 6-week waitlist; (6) no concurrent psy-
chological treatment; (7) fluent in English. Exclusion crite-
ria were as follows: (1) active suicidal ideation and (2)
current psychosis or substance use disorder. Screening, eli-
gibility and participation are shown in Figure 1.
Randomization and blinding
Participants were randomly assigned to CBGT or waitlist
using block randomization, a 1:1 allocation ratio and a
computer-generated assignment sequence prepared prior
to the study. A semi-structured diagnostic interview,
Australian & New Zealand Journal of Psychiatry, 00(0)
4 ANZJP Articles

Table 1.  Six-week CBT protocol for perinatal anxiety session content.

Session CBGT protocol content

1 Introduction and Psychoeducation about Perinatal Anxiety: Prevalence, risk factors and co-occurring mental health
problems; impact of biological and psychosocial changes on mental health; introduction to the cognitive-behavioral
model of perinatal anxiety, the role of thoughts in maintaining distress and symptom monitoring.

2 Identifying and Challenging Unhelpful Thinking: Identifying unhelpful thinking and thinking errors; introduction to
three strategies for cognitive restructuring (i.e. Best Friend Technique, Evidence Technique, Possibility Pie) to
generate more balanced thinking.

3 Helpful vs Unhelpful Worry: Differentiating between productive and unproductive worry; introduction to a
systematic approach to problem-solving for productive worry.

4 Targeting Problematic Behavior: Psychoeducation on the role that behavior can play in maintaining distress;
identifying problematic behavior (e.g. excessive reassurance seeking, excessive checking, avoidance); introduction
to exposure-based behavioral experiments.

5 Managing Depression: Psychoeducation on depressive symptoms in the perinatal period, risk factors and
prevalence; impact that hormones and other biological and psychosocial changes have on mood; introduction to
behavioral activation and activity scheduling. Introduce paced respiration.

6 Assertive Communication: Psychoeducation on assertive and other forms of communication (i.e. passive,
aggressive, passive-aggressive) and their consequences; discussion of situations where assertive communication is
particularly needed in the perinatal period; strategies for increasing assertive communication (e.g. planning for a
strategic approach; assertiveness script; broken record technique).
Wrap-up and summary of learning; strategies for relapse prevention.

A detailed description of session-by-session content of the CBGT protocol can be found in our published manual (Green et al., 2019). CBT:
cognitive behavioral therapy; CBGT: cognitive behavioral group therapy.

self-report measures and clinician-rated measures were
administered at baseline. All measures, with the exception
of the diagnostic interview, were re-administered at
6 weeks post-baseline to all participants and at 3 months
post-treatment for participants randomized to CBGT.
Assessors were blind to treatment condition and timing for
all assessments.
Intervention
The CBGT treatment, based on a published manual (Green
et al., 2019), was designed to be transdiagnostic to target a
range of anxiety symptoms as well as comorbid depressive
symptoms. The treatment involved 6-weekly 2-hour ses-
sions in a small-group format (up to six participants per
group; range = 4–6). Session content was tailored to address
the unique challenges experienced by women with perina-
tal anxiety and depression (see Table 1 for details). Learning
was reinforced with weekly assigned exercises and partici-
pant progress was reviewed each week in group.
Training, supervision and treatment fidelity
Assessors were graduate-level students in clinical psychol-
ogy, trained in conducting diagnostic assessments. Each
treatment group was led by a PhD-level licensed clinical
psychologist and a graduate-level psychology trainee. A
third staff member (e.g. registered nurse) served as an
observer, completing weekly checklists to monitor thera-
pist adherence to the protocol. Supervision for assessments
and therapy was provided by licensed clinical psycholo-
gists (Drs Green and Donegan).
Measures
Baseline characteristics. Sociodemographic variables col-
lected at baseline included age, ethnicity, education, mari-
tal status, perinatal status (pregnant, postpartum) and
psychotropic medication use.
Primary outcome
The State-Trait Inventory for Cognitive and Somatic
Anxiety, Trait Version (STICSA; Grös et al., 2007) was
used to assess self-reported anxiety. The STICSA has excel-
lent psychometric properties and has been validated in a
clinical sample of adults with anxiety disorders (score
range = 21–84; clinical cut-off ⩾43; Grös et al., 2007). As
with all measures in this study, higher scores indicated
greater symptom severity. The internal reliability was
α = .89 in the study sample.
Secondary outcomes
The Penn State Worry Questionnaire (PSWQ; Meyer et al.,
1990) assesses the general tendency to worry, including its

Australian & New Zealand Journal of Psychiatry, 00(0)

Green et al. 5
excessiveness and uncontrollability (range = 16–80; clinical
cut-off ⩾60). The Perceived Stress Scale (PSS-14; Cohen
et al., 1983) measures perceived stress over the past month.
Scores indicate low (0–13), moderate (14–26) or high (27–40)
stress. The Edinburgh Postnatal Depression Scale (EPDS; Cox
et al., 1987) assesses depressive symptoms in the past week
(range = 0–30; clinical cut-off ⩾13). The EPDS has been vali-
dated to assess depressive symptoms in pregnant and postpar-
tum women (Kozinszky and Dudas, 2015). Two clinician-rated
measures were also administered: the Hamilton Anxiety
Rating Scale (HAM-A; Hamilton, 1959) assesses anxiety
symptoms (mild 17, moderate 18–24, severe ⩾25) and the
Montgomery–Åsberg Depression Rating Scale (MADRS;
Montgomery and Åsberg, 1979) assesses depressive symp-
toms (mild 7–19, moderate 20–34, severe ⩾35). The measures
selected for secondary outcomes are commonly used, with
adequate validity and internal reliability (Cohen et al., 1983;
Cox et al., 1987; Fantino and Moore, 2009; Hamilton, 1959;
Kozinszky and Dudas, 2015; Maier et al., 1988; Meyer et al.,
1990; Montgomery and Åsberg, 1979).
Client satisfaction with treatment
The Client Satisfaction Questionnaire (CSQ; Larsen et al.,
1979) has adequate validity and internal reliability
(Attkisson and Zwick, 1982) and was administered imme-
diately following CBGT to assess the acceptability and per-
ceived benefits of treatment.
Statistical analysis
Participants in CBGT and waitlist were compared on base-
line clinical and demographic characteristics with inde-
pendent-sample t tests or chi square (χ2). An intention-to-treat
(ITT) approach and mixed effects analyses of covariance
(ANCOVAs) were used to compare the effectiveness of
CBGT to waitlist from baseline to 6 weeks post-baseline.
Covariates were (1) medication use (taking or not taking
medication for anxiety or depressive symptoms) and (2) per-
inatal status (pregnant or post-partum). A last-observation-
carried-forward approach was used for missing data due to
drop-outs at 6 weeks post-baseline. Within-group compari-
sons and the maintenance of gains among treatment com-
pleters in CBGT by 3-month follow-up were assessed with
paired-samples t tests. Partial eta-squared (η2p) and Cohen’s
d values (post-treatment mean − 3-month follow-up mean/
pooled standard deviation) were computed to estimate
effect sizes. Statistical analyses were conducted using IBM
SPSS Statistics (Release 25).
Results
Participant characteristics at baseline
Following randomization (but before starting treatment),
seven participants assigned to CBGT declined further par-
ticipation or became ineligible and were excluded from
analyses (see Figure 1). This resulted in an ITT sample of 86
participants (Mage = 31.91 years, SD = 3.61, range = 22–41).
One-third of participants (n = 31; 36.0%) were pregnant and
two-thirds (n = 55; 64.0%) were within the first 6 months
postpartum. Approximately one-third of participants (n = 33;
38.4%) were taking psychotropic medication for anxiety or
depressive symptoms. All participants met DSM-5 diagnos-
tic criteria for at least one anxiety disorder. Principal anxiety
disorders were generalized anxiety disorder (n = 73; 84.9%),
social anxiety disorder (n = 8; 9.3%), panic disorder (n = 2;
2.3%) and other specified anxiety disorder (n = 3; 3.5%).
About one-third of participants (n = 31; 39.7%) met diagnos-
tic criteria for at least one secondary anxiety disorder or
obsessive-compulsive disorder, illness anxiety disorder or
post-traumatic stress disorder. Approximately one-third of
participants (n = 25; 29.1%) met diagnostic criteria for a sec-
ondary depressive disorder (e.g. major depressive disorder).
There were no significant between-group baseline differ-
ences on demographic or clinical variables (Table 2).
Intervention engagement, treatment
discontinuation and therapist adherence
Participant drop-outs from CBGT (n = 3) had completed
only one to four treatment sessions or did not provide
6-week post-baseline data. Participant drop-outs from wait-
list (n = 4) did not provide 6-week post-baseline data. The
difference in participant drop-outs between groups was not
statistically significant, χ2 (1) = 0.18, p = .67. In each CBGT
session, raters assessed therapist adherence to the protocol
using a pre-determined content checklist. Therapist adher-
ence was high, with therapists delivering 98.7% to 100% of
prescribed content across sessions.
Primary outcome
A mixed-effects ANCOVA was conducted on the STICSA
from baseline to 6 weeks post-baseline, with medication
use and perinatal status as covariates. All ANCOVA results
are reported in Table 3. There was a significantly greater
reduction on the STICSA in CBGT compared to waitlist,
F(1, 78) = 18.25, p < .001, η2p = .19. There was also a sig-
nificant interaction between medication use, maternal sta-
tus and anxiety symptoms over time, F(1, 78) = 4.15,
p = .045, η2p = .05, such that women who were pregnant and
taking medication were more anxious at baseline than preg-
nant women who were not taking medication, mean differ-
ence = 9.38, p = .03. However, neither medication use nor
maternal status was a significant moderator of the effect of
condition. There were no other statistically significant
interactions with covariates (all p > .05). Finally, when
mean STICSA scores were directly compared at 6 weeks
post-baseline, participants in CBGT reported significantly
lower anxiety symptoms compared to participants in wait-
list, t(84) = 2.39, p = .02, d = 0.52.
Australian & New Zealand Journal of Psychiatry, 00(0)
6 ANZJP Articles

Table 2.  Baseline demographic and clinical characteristics by intervention group.

Baseline characteristics CBT (n = 44) Waitlist (n = 42) p value (t/χ2 test)

Age, mean (SD), years 32.36 (3.54) 31.43 (3.66) .23

Ethnicity .29
  African American 0 (0) 1 (2.4)  
  Asian/Pacific Islander 1 (2.3) 0 (0)  
  Hispanic/Latin American 0 (0) 2 (4.8)  
 White/European 40 (90.9) 38 (90.5)  
 Other 3 (6.8) 1 (2.4)  

Marital status .26

 Single 5 (11.4) 2 (4.8)  
 Married/common-law 39 (88.6) 40 (95.2)  

Education level .47

  High school 4 (9.1) 4 (9.5)  
  Certificate/professional diploma 14 (31.8) 13 (31.0)  
  Bachelor’s degree 15 (34.1) 17 (40.5)  
  Post-graduate degree (MA, PhD, MD) 11 (25.0) 8 (19.1)  

Maternal status .95

 Pregnant 16 (36.4) 15 (35.7)  
 Postpartum 28 (63.6) 27 (64.3)  

Taking psychotropic medication 16 (36.4) 17 (40.5) .70

Psychiatric diagnoses  
  GAD as principal diagnosis 37 (15.9) 36 (85.7) .83
  Secondary mood disorder (MDD, PDD) 13 (29.5) 12 (28.6) .92

Data are presented as n (%) of patients unless otherwise indicated. χ2 = chi-square test of difference between groups. CBT: cognitive behavioral
therapy for perinatal anxiety; SD: standard deviation; GAD: generalized anxiety disorder; MDD: major depressive disorder; PDD: persistent
depressive disorder.

CBGT and waitlist were also compared on the percent-
age of participants whose scores fell above the clinical cut-
off on the STICSA (⩾43; Grös et al., 2007). The majority
of participants in CBGT (n = 30, 68.2%) and waitlist (n = 25,
61.9%) had scores above the clinical cut-off at baseline
(χ2(1) = 0.37, p = .40). At 6 weeks post-baseline, only 36.4%
(n = 16) of participants in CBGT fell above the clinical cut
off, whereas the majority in waitlist (n = 25, 59.5%)
remained above. This difference was statistically signifi-
cant (χ2(1) = 4.62, p = .03).
Secondary outcomes
Mixed effects ANCOVAs were conducted on secondary
outcomes from baseline to 6 weeks post-baseline, with
medication use and perinatal status as covariates. There
were significantly greater reductions in CBGT in self-
reported worry (PSWQ), F(1, 78) = 31.25, p < .001,
η2p = .29; depressive symptoms (EPDS), F(1, 78) = 28.76,
p < .001, η2p  = .27; and perceived stress (PSS), F(1,
78) = 37.54, p < .001, η2p = .33, compared to waitlist. There
were no significant interactions with maternal status or
medication use (all p > .05). When directly compared to
waitlist participants at 6 weeks post-baseline, participants
in CBGT reported significantly lower levels of worry,
PSWQ, t(84) = 6.0, p < .001, d = 1.30; depressive symp-
toms, EPDS, t(84) = 4.80, p < .001, d = 1.03; and perceived
stress, PSS, t(84) = 5.23, p < .001, d = 1.13.
CBGT and waitlist were compared on the percentage of
participants who were above the clinical cut-off on the
EPDS (⩾13; Cox et al., 1987) at baseline and 6 weeks
post-baseline. At baseline, half of participants in CBGT
(n = 22, 50.0%) and on waitlist (n = 22, 47.6%) had scores
above the clinical cut-off, χ2(1) = 0.05, p = .83. However, at
6 weeks post-baseline, only 15.9% (n = 7) in CBGT versus
54.8% (n = 23) in waitlist were above the clinical cut-off.
This difference was statistically significant, χ2(1) = 14.28,
p < .001.

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Green et al. 7

Table 3.  Mixed effects ANCOVAs comparing CBGT (n = 44) to waitlist (n = 42) on outcomes from baseline to 6 weeks
post-baseline.

CBGT Waitlist

Baseline 6-weeks post Baseline 6-weeks post

  M (SD) M (SD) M (SD) M (SD) F(1, 78) p value η2p

Self-reported symptoms

  Anxiety (STICSA) 48.60 (12.03) 41.59 (10.94) 46.21 (9.08) 47.19 (10.76) Time 11.45 .001 .13
  Group × Time 18.25 <.001 .19
  Worry (PSWQ) 66.34 (8.64) 53.05 (10.77) 66.26 (7.70) 65.21 (7.74) Time 45.71 <.001 .37
  Group × Time 31.25 <.001 .29
  Perceived stress (PSS) 31.09 (7.71) 23.59 (7.69) 29.77 (5.46) 32.01 (7.23) Time 12.60 .001 .14
  Group × Time 37.54 <.001 .33
 Depressive symptoms (EPDS) 12.93 (4.33) 8.58 (4.03) 12.40 (4.32) 13.07 (4.63) Time 15.99 <.001 .17
  Group × Time 28.76 <.001 .27

Clinician-rated symptoms
  Anxiety (HAM-A) 16.18 (7.47) 11.31 (6.12) 16.90 (6.58) 16.48 (7.11) Time 21.12 <.001 .21
  Group × Time 14.99 <.001 .16
 Depressive symptoms (MADRS) 13.60 (5.47) 10.19 (4.97) 15.30 (5.61) 14.70 (6.62) Time 19.22 <.001 .20
  Group × Time 9.37 .003 .11

ANCOVA: analysis of covariance; CBGT: cognitive behavioral group therapy for perinatal anxiety; SD: standard deviation; η2p: partial eta-squared;
STICSA: State-Trait Inventory of Cognitive and Somatic Anxiety, Trait Version; PSWQ: Penn State Worry Questionnaire; PSS: Perceived Stress
Scale; EPDS: Edinburgh Postnatal Depression Scale; HAM-A: Hamilton Anxiety Rating Scale; MADRS: Montgomery–Åsberg Depression Rating Scale.

With respect to clinician-rated anxiety (HAM-A), there Treatment satisfaction

was a significantly greater reduction in anxiety symptoms
in CBGT compared to waitlist, F(1, 78) = 14.99, p < .001,
η2p = .16. There was also a significant interaction between
medication use, maternal status and anxiety symptoms
over time, F(1, 78) = 5.60, p = .02, η2p = .07. Specifically, at
baseline, women who were pregnant and taking psycho-
tropic medication were more anxious than pregnant women
who were not taking medication, mean difference = 6.87,
p = .02. However, as with the STICSA, neither medication
use nor maternal status was a significant moderator of the
effect of condition (all p > .05). Participants in CBGT
were also rated by clinicians as having significantly lower
anxiety scores on the HAM-A compared to waitlist partici-
pants at 6  weeks post-baseline, t(84) = 3.62, p < .001,
d = 0.78.
In terms of clinician-rated depressive symptoms
(MADRS), participants in CBGT experienced a signifi-
cantly greater reduction in depressive symptoms than par-
ticipants in waitlist, F(1, 78) = 9.37, p = .003, η2p = .11.
Neither maternal status nor medication use was a signifi-
cant moderator of condition (all p > .05). Participants in
CBGT were also rated by clinicians as having significantly
lower depressive symptoms on the MADRS compared to
waitlist participants at 6 weeks post-baseline, t(84) = 3.59,
p = .001, d = 0.77.
Participants’ satisfaction with CBGT was assessed at post-
treatment. All participants rated the treatment as ‘excellent’
(95.7%) or ‘good’ (4.3%), reported that treatment helped
them cope ‘better’ (30.4%) or ‘a great deal better’ (69.5%)
with their problems, were ‘very satisfied’ (87.0%) or
‘mostly satisfied’ (8.7%) with treatment and all reported
that they would recommend the treatment to others.
Three-month follow-up
Among women who completed CBGT, gains were main-
tained or further improvements observed, at 3-month fol-
low-up. Specifically, there was a significant mean
reduction in self-reported anxiety (STICSA; MPost = 42.33,
M3mo = 38.78; t(34) = 2.58, p = .02, d = 0.33) from post-
treatment to 3-month follow-up. Gains achieved during
treatment were maintained in all other outcomes, including
worry (PSWQ: MPost = 52.93, M3mo = 50.59; t(34) = 1.42,
p = .17, d  = 0.19), depressive symptoms, (EPDS:
MPost = 8.89, M3mo = 7.52; t(34) = 1.78, p = .09, d = 0.21) and
perceived stress (PSS: MPost = 23.10, M3mo = 22.14;
t(34) = 0.76, p = .46, d = 0.11) as well as clinician-rated
anxiety (HAM-A: MPost = 11.07, M3mo = 9.04; t(34) = 1.75,
p = .09, d = 0.35) and depressive symptoms (MADRS:
MPost = 9.50, M3mo = 7.79; t(34) = 1.35, p = .19, d = 0.31).

Australian & New Zealand Journal of Psychiatry, 00(0)

8 ANZJP Articles
Discussion
Best practice guidelines (e.g. McAllister-Williams et al.,
2017; MacQueen et al., 2016) recommend non-pharmaco-
logical interventions as first-line treatments for women
with perinatal anxiety disorders. Despite a small number of
promising studies demonstrating that CBT can be effective
in reducing anxiety among pregnant and postpartum
women, limitations in the existing literature suggest that
the evidence thus far must be considered preliminary
(Goodman et al., 2016; Maguire et al., 2018). The aim of
this study was to add to the emerging treatment outcome
literature by evaluating a new CBGT protocol for women
with perinatal anxiety disorders with or without comorbid
depression. The findings indicate that women in CBGT
experienced significantly greater reductions in both self-
reported and clinician-rated anxiety symptoms compared to
women on the waitlist. Furthermore, a majority of partici-
pants in CBGT (but not in waitlist) scored below the clini-
cal cut-off on self-reported anxiety symptoms (STICSA).
These gains were maintained at 3-month follow-up with
one notable exception: women who completed CBGT
showed continued reductions in self-reported anxiety in the
3 months following treatment. This indicates that women
can continue to benefit from the CBGT intervention once
treatment has ended. Finally, women participating in CBGT
experienced these benefits regardless of maternal status
(pregnant, postpartum) and psychotropic medication use.
CBGT was also effective in reducing secondary symp-
toms, including worry and perceived stress, again regardless
of maternal status or medication use. Worry is a common
symptom across anxiety disorders (Drost et al., 2014) and
therefore an important target in a transdiagnostic treatment.
Importantly, the magnitude of the between-group difference
in worry at 6 weeks post-baseline was comparable to studies
evaluating CBT for anxiety disorders in non-perinatal sam-
ples (Covin et al., 2006; Gould et al., 1997; Otto, 2005). In
addition, the positive impact of CBGT on stress is encourag-
ing given that stress is associated with adverse outcomes in
the perinatal period (Navarro et al., 2008).
The high comorbidity between anxiety and depression
in the perinatal period makes it imperative that treatments
target both in an effective manner. This is particularly true
given that depression is also associated with adverse peri-
natal outcomes (Alder et al., 2007; Andersson et al., 2004;
Berle et al., 2005). To our knowledge, our CBGT protocol
is one of the first protocols to target anxiety disorders as
principal diagnoses while also including components that
directly target depressive symptoms. With that, CBGT was
found to be significantly more effective in reducing both
self-reported and clinician-rated depressive symptoms.
Furthermore, only a minority of participants who com-
pleted CBGT (15.9%) were in the clinical range for depres-
sive symptoms (EPDS) by post-treatment.
Australian & New Zealand Journal of Psychiatry, 00(0)
Strengths
This study aimed to address several limitations in the
existing literature on CBT for perinatal mental health
problems using an RCT design, an adequate sample size, a
range of outcomes and CBT interventions relevant to peri-
natal mental health conditions and a protocol that directly
targets both anxiety and depressive symptoms. The
between-group effect sizes reported in this study ranged
from medium (STICSA, HAM-A and MADRS) to large
(PSWQ, PSS, EPDS) in magnitude. These effect sizes are
well within the range of between-group effect sizes
reported in the small number of RCTs that have been con-
ducted on CBT for perinatal mental health problems to
date (see, for example, Maguire et al., 2018, for a review)
and are also within the range of the effect sizes reported in
meta-analyses evaluating CBT protocols for adults with
anxiety disorders in the non-perinatal literature (e.g. Covin
et al., 2006; Gould et al., 1997; Otto, 2005). Moreover, this
study demonstrated the benefits of CBGT even when con-
trolling for maternal status (i.e. pregnancy, postpartum)
and pharmacotherapy use.
Limitations
Limitations to this study include a relatively short (3-month)
follow-up. Other studies evaluating CBT protocols for peri-
natal mental health problems have used longer follow-up
periods (e.g. 6–9 months; Milgrom et al., 2015; Misri et al.,
2004). A longer follow-up (even 1 or 2 years in duration)
would help determine whether the benefits of CBGT last
beyond the postpartum period. Furthermore, this study did
not investigate the potential impact of CBGT on infant
developmental outcomes. Future studies should examine
outcomes associated with infant development and well-
being (e.g. cognitive or emotional development) in both
short- and long term. Furthermore, future studies would
benefit from a comparison of CBGT with other active
interventions.
Conclusion
Despite evidence that CBT is effective for anxiety disorders
in non-perinatal populations, little research has examined
the benefits of CBT for pregnant and postpartum women
with principal anxiety disorder diagnoses. This RCT pro-
vides empirical support for a new group-based CBT proto-
col (CBGT), tailored to meet the unique needs of women
with perinatal anxiety. This brief transdiagnostic protocol is
effective for women who are pregnant or postpartum, with
or without comorbid depression, and regardless of whether
or not they are taking pharmacotherapy, and therefore has
broad practical and clinical utility.
Green et al. 9
Acknowledgements
The authors would also like to extend our sincere gratitude to
additional staff members who helped with this project, including
Peggy Carter-Arrowsmith (RN), Dan-Bi Cho (RN) and Christelle
Tshilenge (RSW), and our team of psychology research assistants,
residents and practicum students at the Women’s Health Concerns
Clinic, St. Joseph’s Healthcare Hamilton.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship and/or publication of this
article.
Funding
The author(s) disclosed receipt of the following financial support
for the research, authorship and/or publication of this article: This
research was funded by a grant from the 2016 Teresa Cascioli
Charitable Foundation Research Award in Women’s Health,
Research Institute of St. Joseph’s Healthcare, awarded to Dr.
Sheryl Green (PI). The funding source had no role in the design,
analysis, interpretation or publication of this study.
ORCID iD
Eleanor Donegan https://orcid.org/0000-0002-5473-649X
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