Sensing Technologies for Maternal Depression Treatment in Low-Resource Settings

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Nepal
Transcultural Psychosocial Organization Nepal
RECRUITING
Kathmandu
Contact Information
Primary
Brandon A Kohrt, MD PhD
bkohrt@gwu.edu
202-741-2888
Backup
Sauharda Rai, PhD
sauharda@gwu.edu
202-741-2888
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 120
Treatments
Active_comparator: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Yale University, Transcultural Psychosocial Organization Nepal, Duke University, University of Witwatersrand, South Africa
Leads: George Washington University

This content was sourced from clinicaltrials.gov