Sensing Technologies for Maternal Depression Treatment in Low-Resource Settings

NCT06253676 | Recruiting DMC

• 1 other identifier: R33MH126877
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Low- and Middle-Income Country; Mental Health; Task-Sharing Intervention / Non-Specialist Intervention; mHealth | Digital Health

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire-9 (PHQ-9)

  9-item self-report scale that assesses severity of depression symptoms * Minimum Value = 0 * Maximum Value = 27 * Higher scores indicate increased severity of depression symptoms

  20 Weeks Following Baseline Assessment

Secondary Outcomes (3)

• Psychological Outcome Profiles Questionnaire (PSYCHLOPS)

  20 Weeks Following Baseline Assessment

• Generalized Anxiety Disorder-7 (GAD-7)

  20 Weeks Following Baseline Assessment

• World Health Organization Disability Assessment Schedule (WHODAS)

  20 Weeks Following Baseline Assessment

Other Outcomes (1)

• Reducing Tension Checklist

  20 Weeks Following Baseline Assessment

Study Arms (2)

Standard Delivery of Problem Management Plus (PM+)

ACTIVE COMPARATOR

For an eligible, consenting mother participant randomized to the comparator arm, our team will not provide her with active passive sensing technology. As such, no passive sensing data regarding maternal activity and health will be transmitted to or made available to trained, non-specialist providers (i.e., 'PM+ helpers'). Following enrollment, the mother participant will undergo the five intervention sessions with an assigned PM+ helper in an in-person capacity. In particular, the helper will only deliver the intervention as originally manualized; in other words, s/he will not integrate key findings/interpretations of the aforementioned passive sensing data into delivery.

Behavioral: Problem Management Plus (PM+)

StandStrong Platform-Informed Delivery of Problem Management Plus (PM+)

EXPERIMENTAL

For an eligible, consenting mother participant randomized to the experimental arm, our team will provide her a smart phone (with EBM application) and her infant with a GPS beacon. Collectively, these passive sensors will non-invasively collect data regarding maternal activity and health (e.g., heart rate, step count, proximity to infant, etc.) from her and the infant. Upon acquisition of said data, we will transmit it to a data analysis engine based in a machine-learning approach and then visualize it within an application (i.e., 'dashboard') available to trained, non-specialist providers (i.e., 'PM+ helpers'). Following enrollment, the mother participant will undergo the five intervention sessions with an assigned PM+ helper in an in-person capacity. In particular, the helper will integrate key findings/interpretations of the aforementioned passive sensing data into delivery of a given session with respect to an adapted fidelity checklist.

Behavioral: Problem Management Plus (PM+)

Interventions

Problem Management Plus (PM+) BEHAVIORAL

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.).

StandStrong Platform-Informed Delivery of Problem Management Plus (PM+); Standard Delivery of Problem Management Plus (PM+)

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mother Age: 15-39 years
• Infant Age: Within 1st 1000 days of life
• Mother PHQ-9 Score: 8+
• Access to a technology charging modality within home
• Will remain in the study area for a minimum of 6 months after enrollment

You may not qualify if:

• Mother PHQ-9 Score: Less Than 8
• Different permanent residences of mother and infant at time of recruitment
• Acute medical need or hospitalization of mother or infant at time of recruitment
• Presentation of psychotic symptoms (as indicated by the psychosis module of the locally validated Community Informant Detection Tool) at time of recruitment

Sponsors & Collaborators

• George Washington University: lead
• Transcultural Psychosocial Organization Nepal: collaborator
• University of Witwatersrand, South Africa: collaborator
• Yale University: collaborator
• Duke University: collaborator

Study Sites (1)

Transcultural Psychosocial Organization Nepal

Kathmandu, 44600, Nepal

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Psychological Well-Being

Condition Hierarchy (Ancestors)

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

Study Officials

• Brandon A Kohrt, MD PhD

  The George Washington University | Center for Global Mental Health Equity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon A Kohrt, MD PhD

CONTACT

202-741-2888; bkohrt@gwu.edu

Sauharda Rai, PhD

CONTACT

202-741-2888; sauharda@gwu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessor masked to trial arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Health, Global Health, and Anthropology

Model Details: Individual-Randomized Controlled Trial

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Our research team will make data available on or following the trial's award end date.
• Access Criteria: Standard access requirements for National Institute of Mental Health Data Archive (NDA)

Locations

NE (1)