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Group CBT for PPD in the Public Health Setting

Primary Purpose

Depression, Postpartum

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group Cognitive Behavioral Therapy
Postnatal Care As Usual
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Postpartum focused on measuring Postpartum Depression, Cognitive Behavioral Therapy, Public Health, Mother, Infant, Emotion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible women will be >18 years of age, understand and speak English (so that they can participate in the CBT group and complete study measures), have an EPDS score between 10 and 23. They will also all be within 12 months of delivering an infant

Exclusion Criteria:

  • Women can have psychiatric comorbidities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder.

Sites / Locations

  • Niagara Region Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control Group

Arm Description

Group CBT for PPD. Women in the treatment group will attend a 9-week group CBT intervention for PPD. This intervention was developed 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, and a new psychoeducational topic is introduced and discussed by women each week.

Standard Care. The usual care group will receive standard care from their family physician and midwife or obstetrician. They will also be made aware of the perinatal programming available to them through Niagara Region Public Health. Women and family physicians will also receive a copy of the Canadian Practice Guidelines for the Treatment of Perinatal Depression.

Outcomes

Primary Outcome Measures

Edinburgh Postnatal Depression Scale (EPDS)
The EPDS will be used to assess maternal depression. A score of >12 is consistent with PPD and changes in scores >4 are indicative of clinically significant improvement.
Mini International Neuropsychiatric Interview - Current Major Depressive Disorder
Used to assess maternal depression.

Secondary Outcome Measures

Penn State Worry Questionnaire (PSWQ)
Maternal Anxiety will be assessed using the Penn State Worry Questionnaire.
Postpartum Bonding Questionnaire
Used to detect disorders of the mother-infant relationship.
Parent-Child Early Relational Assessment
Used to measure the quality of affect and behavior in parent-child interactions.
Social Provisions Scale
Used to measure the degree to which mothers' social relationships provide support
Ages and Stages Questionnaires - Third Edition
Assesses infant communication, motor and socioemotional development using age-specific scales.
Maternal & Infant Healthcare Utilization
Adopted form the Canadian Community Health Survey to track use of healthcare services.
Infant Behaviour Questionnaire-Revised
This scale assesses infant temperament
Face-to-Face Still Face Paradigm
Experimental task used to assess emotion regulation in infants
Parasympathetic Nervous System Functioning: Heart Rate Variability
Used to asses the flexibility of the central and peripheral nervous system to handle stress.
Salivary Cortisol
Used to assess stress reactivity and emotion regulation. Three samples will be taken during each assessment: 10-15 minutes after the beginning of the assessment, 15-20 minutes after the face-to-face still face task and at the end of the visit.
Corticolimbic Brain Function: EEG-Based Frontal Lobe Asymmetry (via MUSE Headband)
Corticolimbic brain activity at the scalp will be assessed using electroencephalography (EEG). Greater left frontal asymmetry (greater activity in the left frontal hemisphere) is thought to reflect positive emotionality and indicate a greater tendency to engage in more adaptive emotion regulation strategies. However greater right activity reflects a tendency to engage in withdrawn behaviours and negative emotionality.

Full Information

First Posted
January 19, 2017
Last Updated
April 13, 2021
Sponsor
McMaster University
Collaborators
Niagara Region Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT03039530
Brief Title
Group CBT for PPD in the Public Health Setting
Official Title
Impact of Public Health Nurse Delivered Group CBT for Postpartum Depression on Women and Their Children: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Niagara Region Public Health

4. Oversight

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

5. Study Description

Brief Summary
Postpartum depression (PPD) affects over 14,000 women in Ontario each year and can have profound effects on mothers, their children, and their families. The cost of one case of PPD exceeds $150,000, a significant proportion of which is related to its impact on offspring. However, difficulties accessing preferred treatments (e.g., psychotherapy) result in fewer than 15% of women receiving care. While Public Health Units have played an important role in PPD detection in Ontario, Public Health Nurses (PHNs) currently lack the skills to deliver evidence-based treatment to women. Cognitive Behavioural Therapy (CBT) delivered in group format is effective for treating depression in the perinatal period, and as PHNs are often the first point of contact for women experiencing PPD, with specialized training it is likely that they can deliver high-quality CBT. The primary objective of this study is to determine if PHNs can be trained to deliver group Cognitive Behavioral Therapy (CBT) to acutely treat PPD, reduce relapse and recurrence, improve mother-infant attachment and parenting and optimize infant emotional functioning.
Detailed Description
In addition to its effects on maternal health, PPD can adversely affect mother-infant attachment, parenting, and the development and health of her children. The negative effects of PPD on offspring can include an increased risk of insecure attachment, poorer cognitive, language, and behavioral development, as well as an increased risk of emotion regulatory problems. To determine if PHNs can effectively deliver group CBT for PPD that is superior to postnatal care as usual, the investigators will proceed with a randomized controlled trial (RCT). Women in the treatment group will attend a 9-week group CBT intervention delivered by trained PHNs. Those in the control group will receive standard postnatal care. This RCT will compare the effects of group CBT to postnatal care as usual on maternal depression, anxiety, mother-infant attachment, parenting, healthcare utilization and social support, as well as infant development, emotion regulation, and healthcare utilization

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum
Keywords
Postpartum Depression, Cognitive Behavioral Therapy, Public Health, Mother, Infant, Emotion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Group CBT for PPD. Women in the treatment group will attend a 9-week group CBT intervention for PPD. This intervention was developed 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, and a new psychoeducational topic is introduced and discussed by women each week.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Standard Care. The usual care group will receive standard care from their family physician and midwife or obstetrician. They will also be made aware of the perinatal programming available to them through Niagara Region Public Health. Women and family physicians will also receive a copy of the Canadian Practice Guidelines for the Treatment of Perinatal Depression.
Intervention Type
Behavioral
Intervention Name(s)
Group Cognitive Behavioral Therapy
Intervention Description
9 weekly 2-hour group CBT sessions delivered by 2 trained Public Health Nurses.
Intervention Type
Behavioral
Intervention Name(s)
Postnatal Care As Usual
Intervention Description
Postnatal care as usual will involve treatment from their family physician and midwife or obstetrician, and voluntary participation in programs offered by Niagara Region Public Health and in the community.
Primary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
The EPDS will be used to assess maternal depression. A score of >12 is consistent with PPD and changes in scores >4 are indicative of clinically significant improvement.
Time Frame
6 months
Title
Mini International Neuropsychiatric Interview - Current Major Depressive Disorder
Description
Used to assess maternal depression.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Penn State Worry Questionnaire (PSWQ)
Description
Maternal Anxiety will be assessed using the Penn State Worry Questionnaire.
Time Frame
6 months
Title
Postpartum Bonding Questionnaire
Description
Used to detect disorders of the mother-infant relationship.
Time Frame
6 months
Title
Parent-Child Early Relational Assessment
Description
Used to measure the quality of affect and behavior in parent-child interactions.
Time Frame
6 months
Title
Social Provisions Scale
Description
Used to measure the degree to which mothers' social relationships provide support
Time Frame
6 months
Title
Ages and Stages Questionnaires - Third Edition
Description
Assesses infant communication, motor and socioemotional development using age-specific scales.
Time Frame
6 months
Title
Maternal & Infant Healthcare Utilization
Description
Adopted form the Canadian Community Health Survey to track use of healthcare services.
Time Frame
6 months
Title
Infant Behaviour Questionnaire-Revised
Description
This scale assesses infant temperament
Time Frame
6 months
Title
Face-to-Face Still Face Paradigm
Description
Experimental task used to assess emotion regulation in infants
Time Frame
6 months
Title
Parasympathetic Nervous System Functioning: Heart Rate Variability
Description
Used to asses the flexibility of the central and peripheral nervous system to handle stress.
Time Frame
6 months
Title
Salivary Cortisol
Description
Used to assess stress reactivity and emotion regulation. Three samples will be taken during each assessment: 10-15 minutes after the beginning of the assessment, 15-20 minutes after the face-to-face still face task and at the end of the visit.
Time Frame
6 months
Title
Corticolimbic Brain Function: EEG-Based Frontal Lobe Asymmetry (via MUSE Headband)
Description
Corticolimbic brain activity at the scalp will be assessed using electroencephalography (EEG). Greater left frontal asymmetry (greater activity in the left frontal hemisphere) is thought to reflect positive emotionality and indicate a greater tendency to engage in more adaptive emotion regulation strategies. However greater right activity reflects a tendency to engage in withdrawn behaviours and negative emotionality.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible women will be >18 years of age, understand and speak English (so that they can participate in the CBT group and complete study measures), have an EPDS score between 10 and 23. They will also all be within 12 months of delivering an infant Exclusion Criteria: Women can have psychiatric comorbidities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder.
Facility Information:
Facility Name
Niagara Region Public Health
City
Thorold
State/Province
Ontario
ZIP/Postal Code
L2V 4Y6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35060398
Citation
Van Lieshout RJ, Layton H, Savoy CD, Haber E, Feller A, Biscaro A, Bieling PJ, Ferro MA. Public Health Nurse-delivered Group Cognitive Behavioural Therapy for Postpartum Depression: A Randomized Controlled Trial. Can J Psychiatry. 2022 Jun;67(6):432-440. doi: 10.1177/07067437221074426. Epub 2022 Jan 21.
Results Reference
derived

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Group CBT for PPD in the Public Health Setting

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