Clinical trial NCT04480021: Mobile Mental Health in Community-Based Organizations
Official title: Mobile Mental Health in Community-Based Organizations: A Stepped Care Approach to Women's Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-07-21
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Resident of the village (i.e. not a guest attendee)
* Plans to attend CBO meetings regularly.

Exclusion Criteria:

* Diagnosed with severe mental illness such as bipolar disorder or schizophrenia (measured by self report / socio demographic questionnaire)
* Suicide attempt or severe alcohol or substance use in the past 6 months (measured by self report / socio demographic questionnaire)
* Unable to participate in informed consent discussion

Primary outcomes:
measure: Usage Rates
timeFrame: 3 months
Secondary outcomes:
measure: Depression
timeFrame: Change from baseline depression score (QIDS SR) at 3 months
measure: Depression
timeFrame: Change from baseline depression score (QIDS SR) at 6 months
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: St. John's Research Institute
Study officials:
affiliation: University of Washington
name: Amritha S Bhat, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: