Online Transdiagnostic Group CBT for Postpartum Depression and Anxiety

NCT ID: NCT07162129

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-09
• Study Completion Date: 2026-09-30

Brief Summary

The purpose of this pilot study is to test the feasibility of an online 10-Week group cognitive behavioural therapy (CBT; a type of talking therapy) intervention for postpartum depression and anxiety that is led by psychotherapists, social workers, a psychologist and/or a psychiatrist. Mothers and birthing parents who are 18 years or older, have an infant under 12 months, living in Ontario and who have postpartum depression and/or anxiety symptoms will be assigned with a 50/50 chance (like flipping a coin) to receive online transdiagnostic group CBT in addition to usual postnatal care, or to receive usual postnatal care only.

Detailed Description

This study will involve a pilot randomized controlled trial (RCT) to determine the feasibility of a 10-week group CBT intervention for treating postpartum depression and anxiety and study procedures. Primary feasibility objectives include recruitment, completion of study measures, retention and participant satisfaction/acceptability of the intervention. The secondary objective of the pilot RCT is to estimate the treatment effects on PPD and anxiety symptoms to guide the conduct of a future full-scale RCT of the intervention.

48 Participants will be assigned in a 1:1 ratio to the experimental (transdiagnostic CBT group plus treatment as usual (TAU)) or control group (TAU alone). Participants in both groups will complete all study questionnaires at baseline (T1), 10 weeks later (T2 - immediately post-intervention in the experimental group to assess effectiveness), and 6 months after enrollment (T3 - intervention durability). Participants in the treatment group will complete a satisfaction questionnaire with three open-ended questions that will explore their experiences and recommendations for improving the intervention.

Conditions

Postpartum Depression (PPD); Postpartum Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

10-week Transdiagnostic Group CBT Intervention

The experimental group will receive a 10-week transdiagnostic group CBT intervention delivered by a pair of trained mental health providers (psychiatrists, psychologists, social workers, nurses and/or registered psychotherapists) in addition to receiving treatment as usual.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). Each session will be two hours in duration. The 1st hour involves teaching and practice of CBT skills followed by one hour of unstructured discussion about topics relevant to PPD and PPA (sleep, supports, transitions). Each group will be delivered online via Zoom and guided by our intervention manual.

Control - usual care

Participants randomized to the No Intervention group will continue to receive treatment as usual (standard postnatal care). A list of resources will be emailed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety

Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). Each session will be two hours in duration. The 1st hour involves teaching and practice of CBT skills followed by one hour of unstructured discussion about topics relevant to PPD and PPA (sleep, supports, transitions). Each group will be delivered online via Zoom and guided by our intervention manual.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥18 years old
• have an infant <12 months at recruitment
• fluent in written/spoken English
• have an EPDS score ≥10 and/or a GAD-7 score≥10
• live in Ontario, Canada

Exclusion Criteria

• does not meet diagnostic criteria for bipolar, psychotic, borderline personality and current substance use disorders

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Ryan Van Lieshout, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

Group CBT for PPD & PPA Pilot

Identifier Type: -

Identifier Source: org_study_id