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COMMIT Depression Trial Nepal

COMMIT Depression Acceptability and Feasibility Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04510909
Enrollment
86
Registered
2020-08-12
Start date
2020-08-31
Completion date
2021-09-30
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

low- and middle-income countries, mHealth, human-centered design and engineering, digital tools, Nepal, motivational interviewing, non-physician healthcare workers, community health workers, depression

Brief summary

Community health workers (CHWs) have successfully used Motivational Interviewing (MI) to improve treatment adherence (i.e. taking medications and attending clinic appointments) for patients with depression in the US and globally. Mobile health (mHealth) tools can address challenges in implementing MI by providing real-time support in the community and facilitating ongoing coaching and supervision for CHWs, as these two challenges currently impede CHWs' ability to use MI. The investigators will develop then test a new mHealth app, which can potentially be used in the US and abroad, to help CHWs receive decision-support for MI and capture consented audio recordings of patient interactions for review and feedback by facility-based nurses with MI expertise.

Interventions

The investigators will develop Community-based mHealth Motivational Interviewing Tool (COMMIT) using iterative design and testing with frequent, structured input from the key stakeholders: community health workers (CHWs), their supervisors and adult depression patients.The tool will be used by community CHWs in Dolakha, Nepal to: 1) obtain decision-support to deliver motivational interviewing (MI) for patients in their communities, and 2) capture consented audio recordings of client interactions for review and feedback by their supervisors, allowing CHWs to maintain MI skills beyond the initial training period.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, San Francisco
CollaboratorOTHER
Icahn School of Medicine at Mount Sinai, Department of Health Systems Design and Global Health
CollaboratorUNKNOWN
Nyaya Health Nepal
CollaboratorUNKNOWN
Ministry of Health and Population, Nepal
CollaboratorOTHER_GOV
Possible
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Inclusion criteria for patient population: a. Adult patients aged 18 or older; AND b. Must have with active diagnosis of moderate to severe depression (last PHQ-9 ≥10) in the electronic health record system at the research performance site in Nepal; AND c. Have poor adherence (did not refill medications 1 week past the expected date and/or missed a scheduled clinic visit by at least 2 weeks; AND d. Must reside in Dolakha, Nepal 2. Inclusion criteria for community health worker or a community health worker supervisor: a. community health workers and their supervisors currently employed by and working at the research performance site, serving communities in Dolakha; AND b. have received training in motivational interviewing and use of the COMMIT mobile application.

Exclusion criteria

1.

Design outcomes

Primary

MeasureTime frameDescription
Depression6 monthsIndividual Patient Health Questionnaire-9 score, measured at baseline and endline, with greater than or equal to 10 as moderate to severe depression (min score=0; max scote=27 with higher score corresponding to poorer health status)
Medication refill percentage2 weeksIndividual depression medication refill percentage over past 2 weeks (percentage of prescribed depression medication not refilled/picked up as measured by limited dataset extraction from electronic health record system; scale of 0-100%; minimum: 0%; maximum: 100%; higher scores correspond to medication refills completed 100% of the time).
Follow-up clinic attendance percentage2 weeksIndividual attendance at follow-up visits measured as a percentage over past 2 weeks (percentage of indicated follow-up clinic visits that occurred as measured by limited dataset extraction from electronic health record system; scale of 0-100%; minimum: 0%; maximum: 100%; higher scores correspond to patients who attend follow-up visits at clinic 100% of the time).

Secondary

MeasureTime frameDescription
Application access and completion percentage6 monthsFrequency of community health worker accessing mobile application during study (number of times mobile application is accessed/data are entered and completed as a proportion of patients assigned for follow-up)
Patient encounter duration6 monthsTotal amount of time spent using mobile application during patient encounter (amount of time spent in the application and at each prompt)
Application error/crash percentage6 monthsFrequency of mobile application displaying error messages or crashing while in use by community health workers during patient encounters (proportion of all patient encounters where an error message/application crashes occurs)

Countries

Nepal

Contacts

Primary ContactBibhav Acharya, MD
Bibhav.Acharya@ucsf.edu9176539358
Backup ContactDuncan Maru, MD, PhD
duncan.maru@mssm.edu2128247950

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026