Online Transdiagnostic Group CBT for Postpartum Depression and Anxiety

NCT07162129 | Active Not Recruiting

• 1 other identifier: Group CBT for PPD & PPA Pilot
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression (PPD); Postpartum Anxiety

Keywords

Transdiagnostic; Postpartum Depression; Postpartum Anxiety; Cognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (4)

• Number of participants recruited in recruitment period

  Recruit and randomize 48 participants (over two groups; 24 experimental, 24 control) in six months

  6 months

• Number of participants who complete all data collection procedures

  75% of participants complete all three questionnaires and structured interviews

  6 months

• Number of participants who complete study (retention)

  75% of participants remain in study until completion

  6 months

• Number of participants who complete the intervention (adherence)

  80% of participants in treatment group complete the intervention

  6 months

Secondary Outcomes (2)

• Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS)

  10 weeks

• Estimate Treatment effect - GAD-7

  10 weeks

Other Outcomes (15)

• Parenting Stress Index (PSI-SF)

  10 weeks

• Parenting Stress Index (PSI-SF)

  6 months

• GAD-7

  6 months

Study Arms (2)

10-week Transdiagnostic Group CBT Intervention

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety

Control - usual care

NO INTERVENTION

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

Interventions

Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety 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.

10-week Transdiagnostic Group CBT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Cognitive Behavioral Therapy; Tuberculin

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and the research coordinator cannot be blinded to group condition though the research assistants making reminder calls and data analysts will not be aware of group status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A parallel-group Ontario-wide RCT with experimental (CBT group) and TAU (control) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control groups.

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 9, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)