NCT04480021

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

July 10, 2020

Results QC Date

June 12, 2024

Last Update Submit

July 17, 2024

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Usage Rates

    The investigators will obtain data on women's rates of use of the MITHRA app - this data will be obtained from the app, enabled by the single user sign on. Only the MITHRA arm will be considered, and completion of 50% of modules will be considered adequate usage.

    3 months

Secondary Outcomes (2)

  • Depression

    Change from baseline depression score (QIDS SR) at 3 months

  • Depression

    Change from baseline depression score (QIDS SR) at 6 months

Study Arms (2)

Multiuser Interactive Health Response Application (MITHRA)

EXPERIMENTAL

Randomization is at the level of the Community Based Organization (CBO). CBOs randomized to MITHRA will have access to the MITHRA app on tablets. MITHRA app will include depression screening and behavioral activation modules.

Behavioral: MITHRA

Enhanced Usual Care (EUC)

PLACEBO COMPARATOR

CBOs randomized to EUC will receive standardized monthly group education (45 min) regarding the symptoms of depression

Behavioral: EUC

Interventions

MITHRABEHAVIORAL

A 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.

Multiuser Interactive Health Response Application (MITHRA)
EUCBEHAVIORAL

Group education on depression by community health workers

Enhanced Usual Care (EUC)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. John's Research Institute

Bengaluru, India

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Limitations and Caveats

Women with severe depression may not attend Self Help Group meetings. The intervention would ideally include a way to involve women with severe depressive symptoms, and ensure that they get the appropriate level of care.

Results Point of Contact

Title
Dr. Amritha Bhat
Organization
University of Washington
amritha@uw.edu
206-543-3117

Study Officials

  • Amritha S Bhat, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Psychiatry

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 21, 2020

Study Start

October 1, 2022

Primary Completion

June 15, 2023

Study Completion

August 7, 2023

Last Updated

August 13, 2024

Results First Posted

August 13, 2024

Record last verified: 2024-07

Locations

IN(1)