Clinical trial NCT04510909: COMMIT Depression Trial Nepal
Official title: COMMIT Depression Acceptability and Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Possible
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of California, San Francisco
name: Icahn School of Medicine at Mount Sinai, Department of Health Systems Design and Global Health
name: Nyaya Health Nepal
name: Ministry of Health and Population, Nepal
First posted: 2020-08-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: Depression
timeFrame: 6 months
measure: Medication refill percentage
timeFrame: 2 weeks
measure: Follow-up clinic attendance percentage
timeFrame: 2 weeks
Secondary outcomes:
measure: Application access and completion percentage
timeFrame: 6 months
measure: Patient encounter duration
timeFrame: 6 months
measure: Application error/crash percentage
timeFrame: 6 months
Other outcomes:
Locations:
city: Sanfebagar-10
country: Nepal
facility: Bayalpata Hospital
state: Achham/Province 7
Study officials:
References: