Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06253676
Study type Interventional
Source George Washington University
Contact Brandon A Kohrt, MD PhD
Phone 202-741-2888
Email bkohrt@gwu.edu
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date August 2026

See also
  Status Clinical Trial Phase
Completed NCT03665038 - A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) Phase 3
Recruiting NCT06042972 - Risk of Maternal Depression From 1 Year to 4 Years Postpartum in Yvelines
Completed NCT04813341 - Effectiveness of Mat Pilates and Aerobic Training on Fatigue and Depression N/A
Terminated NCT04998565 - Add-on Effectiveness of EA or TENS in Early Postpartum Breast Engorgement N/A
Completed NCT04135612 - The Impact of a Daily Smartphone-based Communication Among Postpartum Women on Breastfeeding Rates N/A
Recruiting NCT05595486 - Baby2Home (B2H) Mobile Health Application N/A
Not yet recruiting NCT04516668 - Effect of Tele-consultation in Addition With Psychiatric Follow-up During COVID-19 in Women Who Have Medical History of Post-partum Depression
Completed NCT05215028 - Optimization of Mother-child Dyad Follow-up by a Multidomain Application: Real-world Cross Sectional Study
Recruiting NCT04129476 - Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression N/A
Recruiting NCT04193462 - Relationship-Based Intervention for Post-Partum Depression N/A
Completed NCT03638687 - Neuroimaging Epigenetics of Prospective Postpartum Depression Biomarkers
Active, not recruiting NCT03052374 - Video-Feedback Interaction Guidance for Improving Interactions Between Depressed Mothers and Their Infants ("VID-KIDS") N/A
Active, not recruiting NCT04940585 - ROSE in Sunset Park N/A
Terminated NCT04011592 - Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression Phase 2
Recruiting NCT05887115 - Nurse Family Partnership for Women With Previous Live Births N/A
Completed NCT04818047 - Adaptation and Pilot Testing of Web and Mobile Interface for the VID-KIDS Intervention N/A
Not yet recruiting NCT05643898 - "Mamá, te Entiendo" App-based Intervention for Reducing Depressive Symptoms in Postpartum Women N/A
Terminated NCT04264520 - Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women N/A
Recruiting NCT04845347 - A Wearable Morning Light Treatment for Postpartum Depression N/A
Enrolling by invitation NCT05186272 - mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression Phase 3