COMMIT Depression Trial Nepal

COMMIT Depression Acceptability and Feasibility Trial

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Other: COMMIT mHealth application

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Achham/Province 7
    • Sanfebagar-10, Achham/Province 7, Nepal
      • Bayalpata Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. Exclusion criteria for patient population: patients with bipolar disorder (their treatment will be different from standard antidepressants) and those with substance use or psychotic disorders (their motivational factors will be substantially different from those of other depressed patients).
2. Exclusion criteria for a community health worker or a community health worker supervisor: includes decision not to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pilot arm; Mixed methods, acceptability and feasibility pilot of the COMMIT mHealth application

Other: COMMIT mHealth application; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Individual 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)	6 months
Medication refill percentage	Individual 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).	2 weeks
Follow-up clinic attendance percentage	Individual 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).	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Application access and completion percentage	Frequency 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)	6 months
Patient encounter duration	Total amount of time spent using mobile application during patient encounter (amount of time spent in the application and at each prompt)	6 months
Application error/crash percentage	Frequency 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)	6 months

Collaborators and Investigators

• Sponsor: Possible
• Collaborators: National Institute of Mental Health (NIMH); University of California, San Francisco; Icahn School of Medicine at Mount Sinai, Department of Health Systems Design and Global Health; Nyaya Health Nepal; Ministry of Health and Population, Nepal

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: depression; mHealth; motivational interviewing; Nepal; low- and middle-income countries; human-centered design and engineering; digital tools; non-physician healthcare workers; community health workers
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: COMMITDNepal; 1R21MH116728-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No