Sensing Technologies for Maternal Depression Treatment in Low-Resource Settings

NCT ID: NCT06253676

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2026-08-31

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.

Detailed Description

Among certain low- and middle- income countries, there is a disproportionate level of untreated postpartum depression that presents both acute and long-term risks to a mother's well-being and her child's survival, health, and development. 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 outcomes of these interventions have been mixed. Digital technology, specifically the use of passive sensing data collection to quantitatively asses a mother's health and monitor behavior change, has the potential to improve the effectiveness of non-specialist-delivered interventions.

Per this clinical trial, our research team will expand upon previous pilot work and evaluate the StandStrong intervention, a passive sensing technology-informed intervention adapted for postpartum depression. StandStrong- a passive sensing technology platform that consists of passive sensors (i.e., smartphone and GPS beacon), a passive sensing data visualization application, and a passive data analysis engine based in a modern machine-learning approach- transmits passive sensing data from a given mother and her infant to a trained, albeit non-specialist provider who interprets such data and then personalizes the intervention for her. Throughout the trial, the intervention within which this data will be integrated is 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.).

In particular, our team will conduct a double-arm, single-blind, individual-randomized controlled trial (RCT) that evaluates the clinical efficacy of platform-informed delivery of the intervention as compared to standard delivery of the intervention. We hypothesize that platform-informed delivery will more significantly reduce severity of symptoms- such as depression, anxiety, and quality of life- associated with postpartum depression relative to standard delivery; moreover, we imagine that platform-informed delivery will prove both cost-effective and scalable. Moreover, we will pose recommendations for platform and intervention implementation within the Nepal health system relative to the RE-AIM framework (i.e., Reach; Effectiveness; Adoption; Implementation; Maintenance).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard Delivery of Problem Management Plus (PM+)

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.

Group Type: ACTIVE_COMPARATOR

Problem Management Plus (PM+)

Intervention Type: 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+)

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.

Group Type: EXPERIMENTAL

Problem Management Plus (PM+)

Intervention Type: 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.).

Interventions

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.).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Transcultural Psychosocial Organization Nepal

OTHER

Sponsor Role: collaborator

University of Witwatersrand, South Africa

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Brandon A Kohrt, MD, PhD

Professor of Psychiatry and Behavioral Health, Global Health, and Anthropology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brandon A Kohrt, MD PhD

Role: PRINCIPAL_INVESTIGATOR

The George Washington University | Center for Global Mental Health Equity

Locations

Transcultural Psychosocial Organization Nepal

Kathmandu, , Nepal

Site Status: RECRUITING

Countries

Nepal

Central Contacts

Brandon A Kohrt, MD PhD

Role: CONTACT

bkohrt@gwu.edu

202-741-2888

Sauharda Rai, PhD

Role: CONTACT

sauharda@gwu.edu

202-741-2888

Facility Contacts

Sujen Maharjan

Role: primary

sujen.maharjan@tponepal.org.np

+977 1-4524082

Dristy Gurung

Role: backup

dgurung@tponepal.org.np

+977 1-4524082

Other Identifiers

R33MH126877

Identifier Type: NIH

Identifier Source: org_study_id

View Link