Group Cognitive Behavioural Therapy for Paternal Perinatal Depression

Not Applicable

Recruiting

• Conditions: Perinatal Depression; Fathers

• Registration Number: NCT07166237
• Lead Sponsor: McMaster University

Brief 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Study Start: 2025-09-09
• Study First Posted: 2025-09-10
• Last Update Submitted: 2025-09-19
• Last Update Posted: 2025-09-24
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants recruited in recruitment period	6 months	Recruit and randomize 48 participants (over two groups; 24 experimental, 24 control) in six months
Number of participants who complete all data collection procedures	6 months	75% of participants complete all three questionnaires and structured interviews
Number of participants who complete study (retention)	6 months	75% of participants remain in study until completion
Number of participants who complete the intervention (adherence)	6 months	80% of participants in treatment group complete the intervention

Secondary Outcome Measures

Name	Time	Method
Estimate treatment effect - Edinburgh Postnatal Depression Scale (EPDS)	9 weeks	Perinatal depression (PND) is best conceptualized as a continuous construct with its impact operating across a continuum of severity, and so a continuous measure of PND (EPDS) is our primary outcome. In keeping with most PND RCTs, our primary effectiveness time point is immediately post-treatment (T2). We will also assess the durability of intervention effects at three months post-T2 (T3). 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.

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada