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Peer Administered CBT for PPD (PL-CBT)

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring Postpartum depression, CBT, Lay Peer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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 commodities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder.

Sites / Locations

  • Kids Can Fly

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Immediate Intervention

Wait List Controls

Healthy Controls

Arm Description

Group CBT for PPD. Women in the treatment group will attend a 9-week group Cognitive Behavioural Therapy intervention for PPD. This intervention was developed at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton and 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. The CBT intervention will be delivered by lay-peers.

Group CBT for PPD 9 weeks after enrollment. The women in this arm of the study will receive the same Cognitive Behavioural Therapy intervention as in the immediate intervention arm, however they will begin the CBT group 9 weeks after enrolling in the study.

No treatment. The participants in this arm of the study will not be suffering from postpartum depression and will not receive the Cognitive Behavioural Therapy treatment. Healthy controls will complete study measures upon enrollment in the study, 9 weeks later as well as 6 months later.

Outcomes

Primary Outcome Measures

Edinburgh Postnatal Depression Scale
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.

Secondary Outcome Measures

Postpartum Bonding Questionnaire
Used to detect disorders of the mother-infant relationship.
Social Provisions Scale
Used to measure the degree to which mothers' social relationships provide support.
CCHS Maternal Healthcare Utilization
Adopted from the Canadian Community Health Survey to Track use of healthcare services by mothers and their infant.
Adult Adolescent Parenting Inventory
Used to assess the parenting and child rearing attitudes of parents.
Cognitive Therapy Awareness Scale
Used to assess CBT skill and knowledge and fidelity to the CBT model.
Therapist Evaluation Checklist
Used to assess the quality of CBT practice.
EQ-5D
Used to measure health-related quality of life.
Generalized Anxiety Disorder-7
Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression.
Mini International Neuropsychiatric Interview - Current Major Depressive Disorder
Used to asses maternal depression.

Full Information

First Posted
September 14, 2017
Last Updated
March 22, 2022
Sponsor
McMaster University
Collaborators
Kids Can Fly Brantford
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1. Study Identification

Unique Protocol Identification Number
NCT03285139
Brief Title
Peer Administered CBT for PPD
Acronym
PL-CBT
Official Title
Peer Administered Group Cognitive Behavioural Therapy for Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Kids Can Fly Brantford

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 up to 20% of women and has profound effects on mothers and their infants. Unfortunately, fewer than 15% of women with PPD receive evidence-based care. This is at least partly due to significant difficulties faced by women in accessing cognitive behavioural therapy (CBT), a preferred 1st line treatment. In Ontario at present, there is a significant lack of personnel trained to deliver CBT. This study will utilize a randomized controlled trial design (with wait list controls) and recruit 70 participants to determine if women with a past history of PPD (i.e., lay peers) can be trained to deliver effective group CBT to women with current PPD. If peers can be trained to provide effective CBT, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced.
Detailed Description
Postpartum depression (PPD) affects up to 20% of women and has profound effects on mothers and their infants. Indeed, the cost of one case of PPD is estimated to exceed $150,000. Unfortunately, fewer than 15% of women with PPD receive evidence-based care and this is at least partly due to difficulties accessing treatment, particularly those that are most preferred (e.g., psychotherapy). Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment and that screening only occur in settings where CBT is readily available. In order to increase access to treatment, screening efforts have been undertaken by public health units province-wide. This is despite recommendations that this only be conducted in the setting of timely access to evidence-based psychotherapies (e.g., CBT). The purpose of this study is to apply task shifting to the treatment of PPD by determining if women with a past history of PPD (i.e., lay peers) living in the community can be trained to deliver effective group CBT to women with current PPD. A group CBT intervention for PPD has been developed and validated as well as a training program that pilot data suggests is capable of successfully training public health nurses with little background psychiatric training. This intervention is brief, effective, and generalizable to women with PPD in community. Peer administered interventions (PAIs), those delivered by recovered former patients are increasingly recognized as potentially effective alternatives to traditional mental health care services. Eight lay peers will be trained to deliver our 9-week group CBT treatment. 74 women will be recruited and using a randomized controlled trial design (with wait list controls), it will be determined if lay peers can deliver effective group CBT for PPD. If peers can be trained to provide effective CBT, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced. Providing women with PPD with CBT skills at this crucial stage in life also has the capacity to prevent future depressive relapse with significant benefits for patients, families, employers, and the healthcare system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Postpartum depression, CBT, Lay Peer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Description
Group CBT for PPD. Women in the treatment group will attend a 9-week group Cognitive Behavioural Therapy intervention for PPD. This intervention was developed at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton and 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. The CBT intervention will be delivered by lay-peers.
Arm Title
Wait List Controls
Arm Type
Experimental
Arm Description
Group CBT for PPD 9 weeks after enrollment. The women in this arm of the study will receive the same Cognitive Behavioural Therapy intervention as in the immediate intervention arm, however they will begin the CBT group 9 weeks after enrolling in the study.
Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Description
No treatment. The participants in this arm of the study will not be suffering from postpartum depression and will not receive the Cognitive Behavioural Therapy treatment. Healthy controls will complete study measures upon enrollment in the study, 9 weeks later as well as 6 months later.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
Cognitive Behavioral Therapy 9 weekly 2-hour group CBT sessions delivered by trained lay peers.
Primary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale
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
Secondary Outcome Measure Information:
Title
Postpartum Bonding Questionnaire
Description
Used to detect disorders of the mother-infant relationship.
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
CCHS Maternal Healthcare Utilization
Description
Adopted from the Canadian Community Health Survey to Track use of healthcare services by mothers and their infant.
Time Frame
6 months
Title
Adult Adolescent Parenting Inventory
Description
Used to assess the parenting and child rearing attitudes of parents.
Time Frame
6 months
Title
Cognitive Therapy Awareness Scale
Description
Used to assess CBT skill and knowledge and fidelity to the CBT model.
Time Frame
6 months
Title
Therapist Evaluation Checklist
Description
Used to assess the quality of CBT practice.
Time Frame
6 months
Title
EQ-5D
Description
Used to measure health-related quality of life.
Time Frame
6 months
Title
Generalized Anxiety Disorder-7
Description
Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression.
Time Frame
6 months
Title
Mini International Neuropsychiatric Interview - Current Major Depressive Disorder
Description
Used to asses maternal depression.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 commodities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Van Lieshout, MD, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kids Can Fly
City
Brantford
State/Province
Ontario
ZIP/Postal Code
N3L 3E1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34758210
Citation
Amani B, Merza D, Savoy C, Streiner D, Bieling P, Ferro MA, Van Lieshout RJ. Peer-Delivered Cognitive-Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial. J Clin Psychiatry. 2021 Nov 9;83(1):21m13928. doi: 10.4088/JCP.21m13928.
Results Reference
derived

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Peer Administered CBT for PPD

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