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CBT for Postpartum Depression and Infant Emotion Regulation

Primary Purpose

Postpartum Depression

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group Cognitive Behavioural Therapy (CBT)
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept 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 4-8 months old at enrollment.

Exclusion Criteria:

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

Sites / Locations

  • McMaster UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment (9-week online CBT group)

Control (treatment as usual)

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Brain-to-brain Synchrony (fNIRS)
Changes in Mother-Infant Synchrony: Physiological and behavioural synchrony patterns are thought to shape infant ER development and explain how treating PPD may exert its effects on infants. Brain-to-brain Synchrony (fNIRS): The fNIRS pre-scanning technique will be used.
The Face-to-Face Stillage Paradigm (FFSP)
The Face-to-Face Stillage Paradigm (FFSP) will be used to observe infant emotion regulatory patterns.
Parent-Child Early Relational Assessment (PCERA)
Parent-Child Early Relational Assessment (PCERA) will be used to observe infant emotion regulatory patterns.
Epigenetic Analyses
One saliva sample will be taken from infants and from mothers at each study visit will be used for epigenetic analyses. Epigenetic modifications will be used to mediate and assess the effect of early life interactions on development.

Full Information

First Posted
February 15, 2022
Last Updated
August 24, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT05269732
Brief Title
CBT for Postpartum Depression and Infant Emotion Regulation
Official Title
The Impact of Treating Postpartum Depression on Infant Emotion Regulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
Investigator
Masking Description
The principal investigator, outcome assessors and data analysts will be blinded to participant allocation.
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (9-week online CBT group)
Arm Type
Experimental
Arm 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.
Arm Title
Control (treatment as usual)
Arm Type
No Intervention
Arm Description
The control group will receive standard postnatal care from their obstetrician, midwife, and/or family physician
Intervention Type
Behavioral
Intervention Name(s)
Group Cognitive Behavioural Therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Infant Temperament
Description
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.
Time Frame
6 months
Title
Infant emotion regulation
Description
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.
Time Frame
6 months
Title
Maternal Depression
Description
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.
Time Frame
6 months
Title
Maternal Anxiety
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Brain-to-brain Synchrony (fNIRS)
Description
Changes in Mother-Infant Synchrony: Physiological and behavioural synchrony patterns are thought to shape infant ER development and explain how treating PPD may exert its effects on infants. Brain-to-brain Synchrony (fNIRS): The fNIRS pre-scanning technique will be used.
Time Frame
6 months
Title
The Face-to-Face Stillage Paradigm (FFSP)
Description
The Face-to-Face Stillage Paradigm (FFSP) will be used to observe infant emotion regulatory patterns.
Time Frame
6 months
Title
Parent-Child Early Relational Assessment (PCERA)
Description
Parent-Child Early Relational Assessment (PCERA) will be used to observe infant emotion regulatory patterns.
Time Frame
6 months
Title
Epigenetic Analyses
Description
One saliva sample will be taken from infants and from mothers at each study visit will be used for epigenetic analyses. Epigenetic modifications will be used to mediate and assess the effect of early life interactions on development.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Van Lieshout, MD, PHD
Phone
905-525-9140
Ext
22163
Email
vanlierj@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
John Krzeczkowski, PHD
Phone
4167365117
Email
krzeczkj@yorku.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Van Lieshout, MD, PHD
Organizational Affiliation
Mcmaster
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Van Lieshout, MD, PhD
Phone
1-905-525-9140
Ext
22163
Email
vanlierj@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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CBT for Postpartum Depression and Infant Emotion Regulation

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