Peer Administered CBT for PPD

NCT03285139 | Completed

• 1 other identifier: PL CBT
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Keywords

Postpartum depression; CBT; Lay Peer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Postpartum Bonding Questionnaire

  6 months

• Social Provisions Scale

  6 months

• CCHS Maternal Healthcare Utilization

  6 months

• Adult Adolescent Parenting Inventory

  6 months

• Cognitive Therapy Awareness Scale

  6 months

Study Arms (3)

Immediate Intervention

EXPERIMENTAL

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

Wait List Controls

EXPERIMENTAL

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

Healthy Controls

NO INTERVENTION

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.

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

Cognitive Behavioral Therapy 9 weekly 2-hour group CBT sessions delivered by trained lay peers.

Immediate Intervention; Wait List Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Kids Can Fly Brantford: collaborator

Study Sites (1)

Kids Can Fly

Brantford, Ontario, N3L 3E1, Canada

Location

Related Publications (1)

• 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.

  PMID: 34758210 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ryan Van Lieshout, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry and Behavioural Neurosciences

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 15, 2017
• Study Start: January 3, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: March 23, 2022

Record last verified: 2022-03

Locations

CA (1)