Group CBT for Paternal Perinatal Depression RCT

NCT07758036 | Not Yet Recruiting

• 1 other identifier: 20403
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the proposed study is to determine the effectiveness of an online, 9-week group CBT intervention for paternal perinatal depression in fathers and fathers-to-be. Fathers or fathers-to-be living in Ontario, Canada who have depression symptoms while their partner has been pregnant and/or during the first 18 months of their child's life will be assigned with a 50/50 chance (like flipping a coin) to receive online group CBT in addition to usual care, or to receive usual care only.

Conditions

Perinatal Depression; Fathers

Keywords

cognitive behavioral therapy; paternal depression; perinatal depression; fathers

Outcome Measures

Primary Outcomes (1)

• Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)

  The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PND. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score of ≥10 is consistent with possible PND, ≥13 is consistent with probable PND and changes in scores \>4 are accepted as being indicative of clinically significant change.

  9 weeks

Secondary Outcomes (19)

• Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)

  6 months post enrollment

• Major Depressive Disorder

  9 weeks

• Major Depressive Disorder

  6 months post enrollment

• Anxiety Symptoms - GAD-7

  9 weeks

• Anxiety Symptoms - GAD-7

  6 months post enrollment

Other Outcomes (1)

• Satisfaction with the intervention - Client Satisfaction Questionnaire (CSQ-8)

  9 weeks (immediately post treatment in intervention group)

Study Arms (2)

9-Week Group Cognitive Behavioural Therapy Intervention

EXPERIMENTAL

The experimental group will receive a 9-week group CBT intervention in addition to receiving treatment as usual.

Behavioral: Cognitive Behavioral Therapy for Paternal Perinatal Depression

Control/Usual Care

NO INTERVENTION

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

Interventions

Cognitive Behavioral Therapy for Paternal Perinatal Depression BEHAVIORAL

Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). The weekly group sessions will be two hours long and take place once a week for 9 consecutive weeks. The first hour of the session will involve teaching and practice of CBT skills, followed by one hour of unstructured discussion around topics relevant to participants with paternal perinatal depression. Each group will be delivered online via Zoom and guided by our intervention manual.

9-Week Group Cognitive Behavioural Therapy Intervention

Eligibility Criteria

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

You may qualify if:

• Non-birthing individuals identifying as fathers-to-be (i.e., have a pregnant partner) or fathers who have an infant \<18 months at recruitment
• Fluent in written/spoken English
• Have an EPDS score ≥9
• Live in Ontario

You may not qualify if:

• Free of bipolar, psychotic, borderline personality and current substance use disorders

Sponsors & Collaborators

• McMaster University: lead
• Ottawa Public Health: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4L8, Canada

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Ryan J Van Lieshout, MD, PhD

CONTACT

(905) 522-1155; vanlierj@mcmaster.ca

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 (9-week CBT + TAU) and control (TAU) 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 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)