Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04480021 |
| Other study ID # |
STUDY00010415 |
| Secondary ID |
R21MH124073-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
August 7, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
University of Washington |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
