Clinical Trials Directory

Trials / Completed

CompletedNCT04480021

Mobile Mental Health in Community-Based Organizations

Mobile Mental Health in Community-Based Organizations: A Stepped Care Approach to Women's Mental Health

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
85 (actual)
Sponsor
University of Washington · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

Untreated depression is a significant cause of morbidity and mortality among women in low and middle- income countries (LMIC). The investigators propose to develop and test the feasibility an interactive voice-response, mobile health application (MITHRA) for screening, tracking symptom severity and supporting stepped treatment of depression among women in rural India. The study will lead to the development of a scalable mobile application applicable to other low resource settings, and build research capacity at the India site.

Detailed description

Undiagnosed and untreated depression is a significant cause of morbidity and mortality in low-, middle-income countries (LMIC) such as India. The rates of diagnosis and treatment of depression among women in rural India are disproportionately low despite a primary care based task-sharing model of mentalhealth treatment. Stepped care approaches support appropriate treatment of symptoms while reducing the burden on healthcare systems and mobile technology can reduce the mental health treatment gap given its reach and easy access. However, our preliminary study at a task-sharing care model in rural south India revealed that illiteracy and the practice of sharing mobile phones as a family resource present hurdles to the adoption of mobile mental health (mHealth) based interventions. To date, the feasibility of a community based multiple user mHealth application to screen depression, track symptom severity and support the delivery of stepped care treatment has not been tested in LMIC. Specific Aim 1: In phase I of this exploratory study, the investigators will adopt a user centered participatory approach to design and develop a multiple-user, voice-response, mobile application ("MITHRA"), to be used in community-based organizations for screening, tracking and supporting stepped care treatment for depression, including select modules of the Healthy Activity Program, a brief psychological intervention based on behavioral activation. The application will include audio, video and enhanced touchscreen capabilities, to overcome the barrier of illiteracy and lack of access. Specific Aim 2: In phase II, using a randomized-control design, the investigators will examine feasibility and utility of "MITHRA" deployed at community-based organizations (n=3) vs enhanced usual care (n=3) in community-based organizations (enrolling approximately 60 women). Specific aim 3: Throughout the duration of the funding period the investigators will arrange for mentored participation of Psychiatry and Community Medicine residents from India in the research project with involvement in the entire spectrum of research activities from interview development and conduct to qualitative and quantitative data analysis and manuscript writing and dissemination. This mentored participation will be supported by regular video-conferenced didactic and case presentation sessions on research methodology. The grant will accomplish the goals of developing a unique mobile application that is scalable, examining its feasibility and building research capacity at the research site in India.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMITHRAA mobile based application (app) in CBOs to screen, track and treat mild to moderate depression among low income women using Healthy Activity Program (HAP),a WHO-recommended evidence-based intervention.
BEHAVIORALEUCGroup education on depression by community health workers

Timeline

Start date
2022-10-01
Primary completion
2023-06-15
Completion
2023-08-07
First posted
2020-07-21
Last updated
2024-08-13
Results posted
2024-08-13

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT04480021. Inclusion in this directory is not an endorsement.