NCT07166237

Group Cognitive Behavioural Therapy for Paternal Perinatal Depression

Group Cognitive Behavioural Therapy for Paternal Perinatal Depression: A Pilot Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot randomized controlled trial is to assess the feasibility of offering a 9-week group cognitive behavioural therapy (CBT; a type of talking therapy) led by a psychiatrist and public health nurse to fathers and non-birthing parents who identify as fathers or fathers-to-be (have a partner who is expecting) with perinatal depression. Fathers or fathers-to-be living in Ontario 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.

Detailed description

This study will involve a pilot randomized controlled trial (RCT) to determine the feasibility of the intervention and study protocol for assessing if a 9-week group CBT intervention added to treatment as usual (TAU) can improve paternal perinatal depression symptoms more than TAU alone. The primary objective is to assess feasibility of the intervention including recruitment, completion of study measures, retention, and participant satisfaction/acceptability of the intervention. The secondary objective of the RCT is to estimate treatment effects on depressive symptoms to guide the conduct of a future full-scale RCT of the intervention. Estimate of treatment effect will serve as a primary outcome measure in a later full-scale RCT. Forty-eight participants will be assigned in a 1:1 ratio to the experimental or control group. Participants in both groups will complete online questionnaires and structured telephone interviews at baseline (T1), 9 weeks later (T2 - immediately post-intervention in the experimental group) and 6 months post-enrollment (T3). Those assigned to receive the 9-week CBT group will also be asked questions about their satisfaction with the program and recommendations for improvement.

Conditions

• Perinatal Depression
• Fathers

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Paternal Perinatal Depression	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.

Timeline

• Start date: 2025-09-09
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-09-10
• Last updated: 2026-01-26

Locations

1 site across 1 country: Canada