NCT05269732

CBT for Postpartum Depression and Infant Emotion Regulation

The Impact of Treating Postpartum Depression on Infant Emotion Regulation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine if online group cognitive behavioral therapy (CBT) for maternal postpartum depression (PPD) added to treatment as usual (TAU) leads to greater improvements in infant emotion regulation (ER) than maternal receipt of TAU alone immediately post-treatment and 6 months later. This study will also aim to determine what mechanisms PPD treatment leads to changes in infant ER.

Detailed description

A prospective, single-blind, parallel randomized controlled trial (1:1 ratio) that includes an experimental (receipt of a 9-week group CBT intervention delivered online plus TAU) and control group (TAU alone) to address our objectives. Participants will have an EPDS score of 10 or more and an infant 3-12 months of age and be recruited from the community. The experimental group will receive a validated 9-week online group cognitive behavioral therapy (CBT) intervention on Zoom plus TAU. The control group will receive TAU alone. In both groups, TAU will consist of regular care from their family doctor, midwife, OB/GYN an/or any other types of care they may be accessing. The trial intervention consists of nine, 2-hour sessions occurring once per week. The first half of each session is devoted to core CBT content, including cognitive restructuring. The second half is devoted to group discussions co-led by participants on topics relevant to mothers with PPD (e.g., sleep, supports, role transitions). Groups will be delivered by two trained psychologists, social workers, nurses, and/or psychiatrists. Primary objective: Determine if online group cognitive behavioural therapy (CBT) for maternal PPD added to treatment as usual (TAU) lead to greater improvements in infant ER than maternal receipt of TAU alone immediately post-treatment and 6 months later. Secondary objective: Determine the putative mechanisms through which PPD treatment leads to changes in infant ER.

Conditions

• Postpartum Depression

Interventions

Type	Name	Description
BEHAVIORAL	Group Cognitive Behavioural Therapy (CBT)	The 9-week group Cognitive Behavioural Therapy (CBT) intervention for Postpartum Depression (PPD) delivered via Zoom by two trained psychologists. This intervention was developed by Dr. Van Lieshout (Principal Investigator) at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced each week. The first half of each session is devoted to core CBT content, including cognitive restructuring. The second half is devoted to group discussions co-led by participants on topics relevant to mothers with PPD (e.g., sleep, supports, role transitions). Homework is assigned at each session.

Timeline

• Start date: 2022-06-17
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-03-08
• Last updated: 2024-11-27

Locations

1 site across 1 country: Canada