Remote Peer Support in Prevention of Postpartum Depression
Effectiveness of Remote Peer Support in Prevention of Postpartum Depression: a Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
The project aims to test the clinical effectiveness of the Mom´s Supporting Moms intervention, a newly developed approach to the prevention of postpartum depression (PPD) and to determine its cost-effectiveness. The approach consists of online screening for risk of PPD in obstetric settings, and subsequent remote peer support intervention for women at risk of PPD development. As a preparation for proposed study, investigators have developed the Mom´s Supporting Moms intervention which is based in mother-to-mother delivered psychoeducation, basic procedures of cognitive behavioral therapy and mindfulness, shared personal experience with postpartum depression and, if necessary, referring to a professional consultation. Proposed study will allow investigators to bring missing Czech methodological procedures for the early screening of PPD development risk, and for subsequent non-pharmacological intervention. Further, investigators will be able to present economic data on proposed intervention to relevant stakeholders in mental health policy. To achieve these aims, investigators will 1) set up a screening program in five Czech maternity hospitals 2) conduct a randomized controlled trial (n= 60 per each arm), and 3) conduct a cost-effectiveness analysis of the Mom´s Supporting Moms intervention. Investigators will test the following primary hypotheses: H1: Mom´s Supporting Moms intervention will decrease depressive symptoms in women at risk of PPD development. Secondary hypotheses: SH1: Mom´s Supporting Moms intervention will reduce anxiety symptoms in women at risk of PPD development. SH2: Mom´s Supporting Moms intervention will increase women's health-related quality of life. SH3: Mom´s Supporting Moms intervention is cost-effective in comparison to treatment as usual.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
1 active site
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
November 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 13, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedApril 11, 2022
April 1, 2022
3 years
November 13, 2020
April 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Postpartum depressive symptoms
self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.
6 weeks postpartum
Secondary Outcomes (3)
Postpartum anxiety symptoms
6 weeks postpartum
Postpartum health-related quality of life
6 weeks postpartum
Cost-effectiveness
6 weeks, 3 months, and year 1 postpartum
Other Outcomes (3)
Postpartum depressive symptoms
3 months postpartum
Postpartum anxiety symptoms
3 months postpartum
Postpartum health-related quality of life
3 months postpartum
Study Arms (2)
Mom´s Supporting Mom (MSM)
EXPERIMENTALA preventive intervention that involves psychoeducation and peer techniques described in study detailed description.
Enhanced Treatment as Usual
ACTIVE COMPARATORReferral to treatment in the community and monitoring
Interventions
A preventive peer consultation intervention for Postpartum Depression.
Referral to treatment in the community, clinical monitoring
Eligibility Criteria
You may qualify if:
- sex-female
- childbirth in the hospital
- signing of informed consent
- email address ownership
- age 18 - 45 years
You may not qualify if:
- \- acute medical illness or significant pregnancy complication (based on self-report)
- INTERVENTION PHASE
- Edinburgh Postpartum Depression Scale score ≥10.
- participant identified through the Screening Phase of the study
- \- acute suicidal behavior (based on self-report)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Mental Health
Klecany, 25067, Czechia
Related Publications (1)
Sebela A, Horakova A, Nemcova H, Kuklova M, Noskova E, Svancer P, Byatt N, Janovska A, Hrdlickova K. Mom Supporting Mom: Effective Peer Support Intervention for Women with Postpartum Psychological Distress. Psychosoc Interv. 2025 Jul 29;34(3):151-160. doi: 10.5093/pi2025a12. eCollection 2025 Sep.
PMID: 40765646DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonin Sebela, Ph.D.
National Institute of Mental Health, Klecany, Czechia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The person administering the outcome measures is blind to participant group.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 13, 2020
First Posted
November 20, 2020
Study Start
November 1, 2020
Primary Completion
October 31, 2023
Study Completion
April 30, 2024
Last Updated
April 11, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- After the completion of the study
- Access Criteria
- Permission of the PI
De-identified data may be made available to other researchers.