CBT for Postpartum Depression and Infant Emotion Regulation

McMaster University

Status: Active, not recruiting

Conditions: Postpartum Depression

Treatments: Behavioral: Group Cognitive Behavioural Therapy (CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05269732

PIER CBT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women 18 years of age or older
• understand and speak English (so that they can participate in the CBT group and complete study measures)
• live in Ontario (the primary WHCC catchment area)
• have an EPDS score of 10 or more
• meets diagnostic criteria for comorbid psychiatric conditions.
• Infants must be between 4-12 months old at enrollment.

Exclusion criteria

• bipolar disorder
• a current psychotic disorder
• substance or alcohol use disorder
• antisocial or borderline personality disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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172 participants in 2 patient groups

Treatment (9-week online CBT group)

Experimental group

Description:

Participants assigned to the treatment group will continue to receive any healthcare they might already be receiving (e.g. family doctor, midwife, Obstetrician/Gynecologist, etc.) and participate in a 9-week group Cognitive Behavioral Therapy (CBT) intervention for Postpartum Depression (PPD) delivered via Zoom by two trained psychologists, social workers, nurses, and/or psychiatrists.

Treatment:

Behavioral: Group Cognitive Behavioural Therapy (CBT)

Control (treatment as usual)

No Intervention group

Description:

The control group will receive standard postnatal care from their obstetrician, midwife, and/or family physician