COMMIT Depression Trial Nepal

NCT ID: NCT04510909

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pilot arm

Mixed methods, acceptability and feasibility pilot of the COMMIT mHealth application

Group Type EXPERIMENTAL

COMMIT mHealth application

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai, Department of Health Systems Design and Global Health

UNKNOWN

Sponsor Role collaborator

Nyaya Health Nepal

UNKNOWN

Sponsor Role collaborator

Ministry of Health and Population, Nepal

OTHER_GOV

Sponsor Role collaborator

Possible

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bayalpata Hospital

Sanfebagar-10, Achham/Province 7, Nepal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Nepal

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bibhav Acharya, MD

Role: CONTACT

9176539358

Duncan Maru, MD, PhD

Role: CONTACT

2128247950

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sabitri Sapkota, PhD, MPH

Role: primary

+977 14100597

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R21MH116728-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

COMMITDNepal

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Improving Depression Management
NCT05050227 COMPLETED NA
Improving Help-seeking for Depression Care in Nepal
NCT06574074 ACTIVE_NOT_RECRUITING NA