NCT04913584

Brief Summary

Postpartum depression (PPD) affects up to one in five 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 psychotherapies, their preferred treatment for PPD. Around the world, there is a significant lack of healthcare professionals trained to deliver CBT. This study will utilize a randomized controlled trial design (with wait-list controls) and recruit 174 participants to determine if women with a past history of PPD (i.e., lay peers) can be trained to deliver effective group CBT online to women currently struggling with 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

1.5 years

First QC Date

May 29, 2021

Last Update Submit

April 18, 2022

Conditions

Postpartum Depression

Keywords

Postpartum depressionCBTLay PeerOnline therapy

Outcome Measures

Primary Outcomes (1)

  • Edinburgh Postnatal Depression Scale

    The EPDS will be used to assess maternal depression. A score of \>10 is consistent with probable PPD and changes in scores \>4 are indicative of clinically significant improvement.

    6 months

Secondary Outcomes (10)

  • Postpartum Bonding Questionnaire

    6 months

  • Social Provisions Scale

    6 months

  • Canadian Community Health Survey Maternal Healthcare Utilization

    6 months

  • Adult Adolescent Parenting Inventory

    6 months

  • EuroQol-5D

    6 months

  • +5 more secondary outcomes

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Online Group CBT for PPD. Women in the treatment group will attend an online 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 eight lay-peers.

Behavioral: Cognitive Behavioural Therapy

Wait-List Controls

EXPERIMENTAL

Online 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

Interventions

Cognitive Behavioural TherapyBEHAVIORAL

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

Immediate InterventionWait-List Controls

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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 \>10
  • Be within 12 months of delivering an infant
  • Live within a 2-hour radius of the Brant Region.

You may not qualify if:

  • Bipolar disorder
  • Current psychotic disorder
  • Substance use disorder
  • Alcohol use disorder
  • Antisocial or borderline personality disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kids Can Fly

Brantford, Ontario, N3L 3E1, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral 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

May 29, 2021

First Posted

June 4, 2021

Study Start

August 25, 2020

Primary Completion

February 22, 2022

Study Completion

February 22, 2022

Last Updated

April 19, 2022

Record last verified: 2022-04

Locations

CA(1)