Peer Administered CBT for PPD (PL-CBT)

Peer Administered Group Cognitive Behavioural Therapy for Postpartum Depression

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression
• Intervention / Treatment: Behavioral: Cognitive Behavioural Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brantford, Ontario, Canada, N3L 3E1
      • Kids Can Fly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Intervention; 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.	Behavioral: Cognitive Behavioural Therapy; Cognitive Behavioral Therapy 9 weekly 2-hour group CBT sessions delivered by trained lay peers.
Experimental: Wait List Controls; 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.	Behavioral: Cognitive Behavioural Therapy; Cognitive Behavioral Therapy 9 weekly 2-hour group CBT sessions delivered by trained lay peers.
No Intervention: Healthy Controls; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum Bonding Questionnaire	Used to detect disorders of the mother-infant relationship.	6 months
Social Provisions Scale	Used to measure the degree to which mothers' social relationships provide support.	6 months
CCHS Maternal Healthcare Utilization	Adopted from the Canadian Community Health Survey to Track use of healthcare services by mothers and their infant.	6 months
Adult Adolescent Parenting Inventory	Used to assess the parenting and child rearing attitudes of parents.	6 months
Cognitive Therapy Awareness Scale	Used to assess CBT skill and knowledge and fidelity to the CBT model.	6 months
Therapist Evaluation Checklist	Used to assess the quality of CBT practice.	6 months
EQ-5D	Used to measure health-related quality of life.	6 months
Generalized Anxiety Disorder-7	Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression.	6 months
Mini International Neuropsychiatric Interview - Current Major Depressive Disorder	Used to asses maternal depression.	6 months

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Kids Can Fly Brantford

Publications and helpful links

General Publications

• 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). pii: 21m13928. doi: 10.4088/JCP.21m13928.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: CBT; Postpartum depression; Lay Peer
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: PL CBT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No