Sensing Technologies for Maternal Depression Treatment in Low-Resource Settings

Post Partum Depression Clinical Trial

— StandStrong  

Official title:

Sensing Technologies for Maternal Depression Treatment in Low-Resource Settings

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06253676
• Other study ID #: R33MH126877
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: August 2026

Study information

• Verified date: May 2024
• Source: George Washington University
• Contact: Brandon A Kohrt, MD PhD
• Phone: 202-741-2888
• Email: bkohrt[@]gwu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 39 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post Partum Depression

Intervention

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.).

Locations

Country	Name	City	State
Nepal	Transcultural Psychosocial Organization Nepal	Kathmandu

Sponsors (5)

Lead Sponsor	Collaborator
George Washington University	Duke University, Transcultural Psychosocial Organization Nepal, University of Witwatersrand, South Africa, Yale University

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reducing Tension Checklist	10-item self-report scale that assesses degree of psychosocial skill use; Minimum Value = 0; Maximum Value = 30; Higher scores indicate increased use of psychosocial skills	20 Weeks Following Baseline Assessment
Primary	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	Psychological Outcome Profiles Questionnaire (PSYCHLOPS)	4-item self-report questionnaire that indicates a personalized measure of psychological distress	20 Weeks Following Baseline Assessment
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	7-item self-report scale that assesses severity of generalized anxiety symptoms; Minimum Value = 0; Maximum Value = 21; Higher scores indicate increased severity of generalized anxiety symptoms	20 Weeks Following Baseline Assessment
Secondary	World Health Organization Disability Assessment Schedule (WHODAS)	12-item self-report scale that assesses extent of adult disability; Minimum Value = 0; Maximum Value = 48; Higher scores indicate increased severity of disability	20 Weeks Following Baseline Assessment