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Remote Peer Support in Prevention of Postpartum Depression

NCT04639752 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-04-11

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Mom´s Supporting Mom

A preventive peer consultation intervention for Postpartum Depression.

BEHAVIORAL

Enhanced Treatment As Usual

Referral to treatment in the community, clinical monitoring

Sponsors & Collaborators

  • National Institute of Mental Health, Czech Republic

    lead OTHER

Principal Investigators

  • Antonin Sebela, Ph.D. · National Institute of Mental Health, Klecany, Czechia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2023-10-31
Completion
2024-04-30

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639752 on ClinicalTrials.gov