Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety

Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety: A Randomized Controlled Trial

NCT05510752•St. Joseph's Healthcare Hamilton

Summary

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

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Women 18 and older that are pregnant or between 0-12 months postpartum;
•2. 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;
•3. No concurrent psychological treatment;
•4. 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;
•5. Fluent in English, minimal grade 8 reading level.

Exclusion Criteria

•1. Severe depression/suicidality requiring acute intervention;
•2. Women with psychotic or current substance use disorders,
•3. medication changes in dose or type or less than 5/6 sessions complete (will continue with treatment but be excluded from the study).

Key Dates

Start Date

September 1, 2022

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

August 22, 2022

Enrollment

216

ESTIMATED participants

Conditions

Perinatal Anxiety

Interventions

Cognitive Behavioural Group Therapy

BEHAVIORAL

Psychoeducation

BEHAVIORAL

Contacts

Sheryl M Green, C.Psych

CONTACT

905-522-1155 sgreen@stjoes.ca

Evaluating Overcoming Anxiety in Pregnancy and Postpartum as an Online Self-Directed Program

NCT04844138

Perinatal AnxietyPerinatal Depression

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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