CBT for Postpartum Depression and Infant Emotion Regulation

NCT05269732 | Active Not Recruiting DMC

• 1 other identifier: PIER CBT
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (4)

• Infant Temperament

  Infant Behavior Questionnaire-Revised (IBQ-R): The IBQ-R is a 91-item scale with 14 subscales that measure infant temperament. Temperament refers to the ways individuals think, behave, and react and is heavily influenced by the degree to which infants and toddlers can regulate their emotions. The items on the IBQ ask parents to rate the frequency of specific temperament-related behaviors observed over the past week. Items are scored on a scale of 0-7. Mothers will complete the IBQ-R on their infants immediately before treatment, right after treatment, and at 6 months afterward.

  6 months

• Infant emotion regulation

  Emotional Regulation (ER) is comprised of biological and behavioural domains best measured with validated physiological, observational and informant reports that assess this phenomenon across the full range of infant functioning. Physiological measures: Medial Pre-frontal complex (mPFC) activity using functional near-infrared spectroscopy will be used to observe infant emotion regulatory patterns.

  6 months

• Maternal Depression

  Edinburgh Postnatal Depression Scale (EPDS): The EPDS is the 10-item gold standard measure of maternal depressive symptoms. Scores range from 0-30, with higher scores indicating worse depressive symptoms. Mothers will complete the EPDS immediately before treatment, right after treatment, and at 6 months afterward.

  6 months

• Maternal Anxiety

  The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a self-report scale that taps generalized anxiety disorder, the most common comorbidity of Postpartum Depression (PPD). Scores range from 0-21 with higher scores indicating worse anxiety symptoms. Mothers will complete the GAD-7 immediately before treatment, right after treatment, and at 6 months afterward.

  6 months

Secondary Outcomes (4)

• Brain-to-brain Synchrony (fNIRS)

  6 months

• The Face-to-Face Stillage Paradigm (FFSP)

  6 months

• Parent-Child Early Relational Assessment (PCERA)

  6 months

• Epigenetic Analyses

  6 months

Study Arms (2)

Treatment (9-week online CBT group)

EXPERIMENTAL

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.

Behavioral: Group Cognitive Behavioural Therapy (CBT)

Control (treatment as usual)

NO INTERVENTION

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

Interventions

Group Cognitive Behavioural Therapy (CBT) BEHAVIORAL

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.

Treatment (9-week online CBT group)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ryan Van Lieshout, MD, PHD

  Mcmaster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The principal investigator, outcome assessors and data analysts will be blinded to participant allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to the treatment group (delivered group CBT plus TAU) or the control group (treatment as usual).

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 8, 2022
• Study Start: June 17, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)