Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety
ConditionPerinatal Anxiety
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorSt. Joseph's Healthcare Hamilton
About this trial
Anxiety during pregnancy and the postpartum (perinatal) period is very common and is associated with adverse consequences for mothers and their infants. Currently, medication is the most commonly prescribed treatment for perinatal anxiety and the lack of nonmedication-based interventions for perinatal anxiety is a barrier to receiving effective treatment for many women. As such, the present single-blind, randomized controlled trial seeks to evaluate whether group-based cognitive behavioural therapy, the gold-standard psychological treatment for anxiety disorders in the general population, effectively treats perinatal anxiety symptoms when compared to a psychoeducation group, which is currently the most commonly prescribed non-medication-based treatment for perinatal distress.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women 18 and older that are pregnant or between 0-12 months postpartum;
Principal diagnosis of an anxiety disorder as per the Mini International Neuropsychiatric Interview for DSM-5 (version 7.0.2) with or without comorbid depression;
No concurrent psychological treatment;
Not taking psychoactive medication or a) medications are stable in dose and type for at least 8 weeks prior to the study (as per Canadian psychiatric guidelines; and b) medications remain stable throughout the study;
Disqualifiers
Severe depression/suicidality requiring acute intervention;
Women with psychotic or current substance use disorders,
medication changes in dose or type or less than 5/6 sessions complete (will continue with treatment but be excluded from the study).
Trial design
Design model
Factorial
Treatments tested in this trial
Cognitive Behavioural Group Therapy
BehavioralCBGT is a 6-week group that meets weekly for 2-hours per week, where participants learn cognitive and behavioural techniques to enhance coping skills for their everyday anxieties.
Psychoeducation
BehavioralPsychoeducation is the most common non-pharmacological treatment for perinatal distress, where participants learn about healthy infant milestones and how to implement self-care in their daily lives, which in turn reduces distress during the perinatal period.
Treatment groups
216 Participants
are divided into 2 treatment groupsGroup A: Psychoeducation GroupActive comparator 1 intervention
Group B: Cognitive Behavioural Group TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
The STICSA is a 21-item self-report scale that assesses cognitive and somatic components of anxiety. The STICSA is comprised of a state scale that measures individuals' current anxiety symptoms, and a trait scale that assesses one's proneness to anxiety, more generally. In the present study, only the trait scale of the STICSA will be used. Items are scored on a 4-point scale ranging from 1 ('not at all') to 4 ('very much so'). The STICSA has demonstrated excellent validity and reliability. A cut-off score of 43 or higher on the STICSA has been suggested for detecting a probable anxiety disorder. The STICSA has been validated for use in clinical samples of adults with anxiety disorders, although not explicitly in perinatal samples.
Time frame
Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.Secondary outcomes
1
Penn State Worry Questionnaire (PSWQ)
The PSWQ is a 16-item self-report measure that assesses the tendency to worry. Items are scored on a 5-point scale ranging from 1 ('not typical at all') to 5 ('very typical'), with higher scores reflecting greater pathological worry. A cut-off score of 62 or higher has been suggested for determining a probable GAD diagnosis. The PSWQ has demonstrated excellent internal consistency and validity across various populations and has been validated for use in perinatal samples.
Time frame
Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.2
Generalized Anxiety Disorder 7 (GAD-7)
The GAD-7 is a 7-item self-report measure that assesses anxiety symptom severity over a previous two-week period. Items are measured on a 4-point scale ranging from 0 ('not at all') to 3 ('nearly every day'). A cut-off score of 10 or higher with sensitivity of 89% and specificity of 82% has been suggested for detecting a probable diagnosis of Generalized Anxiety Disorder. The GAD-7 has also been validated for use in perinatal samples.
Time frame
Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.3
Edinburgh Postnatal Depression Scale (EPDS)
The EPDS is a 10-item self-report measure that assesses symptoms of depression during the perinatal period. Items are scored on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater depressive symptomatology. The EPDS has demonstrated good sensitivity and specificity for a diagnosis of Major Depressive Disorder (MDD). Cut-off scores of 15 and 13 or higher have been suggested for detecting a probable diagnosis of MDD during pregnancy and the postpartum period, respectively.
Time frame
Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.4
Worry Behaviors Inventory Perinatal Revised (WBI-P)
The WBI-PR is adapted from the Worry Behaviours Inventory, which assesses the frequency of problematic behaviours associated with generalized anxiety disorder. The WBI-PR is a 10-item self-report measure that is designed to measure problematic GAD behaviours during the perinatal period. Items are measured on a 5-point Likert scale, ranging from 0 to 4 and includes two subscales: Avoidance and Safety Behaviours. In its initial validation, the WBI-PR demonstrated acceptable internal consistency and convergent and discriminant validity.
Time frame
Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.Other outcomes
1
Sociodemographic Factors
Sociodemographic information collected will include participant's gender, age, ethnicity, marital status, education level, income level, parity, medical and delivery history, family psychiatric history, medication usage, and treatment history.
Time frame
Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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