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Sensing Technologies for Maternal Depression Treatment in Low-Resource Settings

NCT06253676 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-06-25

No results posted yet for this study

Summary

In certain low- and middle- income country settings, there is a disproportionate level of untreated postpartum depression that presents both acute and long-term risks to a mother's well-being. Although there is increasing willingness among health systems to involve non-specialists, such as community health workers, in the delivery of psychosocial interventions for postpartum depression, the effectiveness of these interventions has been mixed. The incorporation of digital technology, though, has the potential to improve the effectiveness of non-specialist-delivered interventions.

The goal of this clinical trial is to evaluate the acceptability and clinical efficacy of the StandStrong intervention- a non-specialist, passive sensing technology-informed (i.e., digital) mental health intervention- as compared to a standard non-specialist mental health intervention among postpartum-depressed mothers in Nepal. Successful completion of the trial will contribute to the optimization of psychosocial intervention delivery for the postpartum context in low- and middle-income country settings.

Conditions

  • Post Partum Depression

Interventions

BEHAVIORAL

Problem Management Plus (PM+)

Validated across multiple low- and middle-income country settings, PM+ is World Health Organization-developed, five-session task-sharing intervention for mild to moderate distress. Per the (manualized) intervention, trained non-specialist providers coach eligible clients to address practical problems and/or distress in their daily lives via the use of fundamental cognitive behavioral strategies (e.g., deep breathing and stress management, behavioral activation, strengthening of social support, etc.).

Sponsors & Collaborators

  • Transcultural Psychosocial Organization Nepal

    collaborator OTHER

  • University of Witwatersrand, South Africa

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • George Washington University

    lead OTHER

Principal Investigators

  • Brandon A Kohrt, MD PhD · The George Washington University | Center for Global Mental Health Equity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Nepal

Study Locations

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Entities

Companies

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 NCT06253676 on ClinicalTrials.gov