Group Cognitive Behavioural Therapy for Paternal Perinatal Depression

McMaster University

Status: Enrolling

Conditions: Perinatal Depression; Fathers

Treatments: Behavioral: Cognitive Behavioral Therapy for Paternal Perinatal Depression

Study type: Interventional

Funder types: Other

Identifiers

NCT07166237

CBT for Paternal PND Pilot RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

9-Week Group Cognitive Behavioural Therapy Intervention

Experimental group

Description:

The experimental group will receive a 9-week group CBT intervention delivered by a psychiatrist and a public health nurse in addition to receiving treatment as usual.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Paternal Perinatal Depression

Control/Usual Care

No Intervention group

Description:

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