Clinical Trial

BECOME COmbined Intervention for MH & NCD Delivered by Community Health Workers in Nepal

Study acronym: BECOME
Active, Not Recruiting
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Summary
Common mental health disorders (CMDs) and noncommunicable diseases (NCDs) pose significant public health challenges, especially in resource-limited settings like Nepal. The coexistence of CMDs and NCDs is prevalent, tied together by shared behavioral risk factors including stress, isolation, tobacco use, low physical activity, poor diet, and treatment non-adherence. Addressing these risk factors through behavioral interventions has the potential to positively impact both CMDs and NCDs. While the World Health Organization (WHO) recommends three behavioral interventions-evidence-based stress reduction (EBSR) for stress and anxiety, behavioral activation (BA) for depression, and motivational interviewing (MI) for healthy behaviors-availability remains scarce in low-resource settings. This research proposes a hybrid implementation-effectiveness study of the BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases (BECOME) in Nepal. BECOME, delivered by community health workers (CHWs), integrates EBSR, BA, and MI to improve mental health and address NCDs. The study employs a stepped-wedge cluster randomized trial, with 20 clusters randomly assigned to five steps, starting in the control condition. Transitioning every three months, clusters gradually adopt the intervention, minimizing logistical challenges during implementation. The study targets 700 patient participants (age 40 years and above with at least one CMD and NCD) from Bardibas and Chandragiri municipalities, involving 20 CHWs, five primary care providers (PCPs), and six health system leaders. CHWs identify potential participants, with research staff assessing eligibility, obtaining informed consent, and conducting baseline assessments using a digital REDCap tool. CHWs undergo BECOME intervention training, delivering it to consenting patient participants (30 per CHW). Quantitative data collected quarterly over 12 months will measure primary outcomes for CMDs and NCDs. Additionally, qualitative components, following the Reach Effectiveness-Adoption Implementation and Maintenance (RE-AIM) framework, include focus group discussions (FGDs) with CHWs and Key Informant Interviews (KIIs) with patient participants, PCPs, and health system leaders to assess implementation mechanisms, outcomes, and clinical impact. The study, if successful, aims to furnish evidence and a model for implementing behavioral interventions addressing CMDs and NCDs.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-06-07; most recent amendment 2026-04-09.
Status change: Recruiting → Active, Not Recruiting 2026-04-09
Status change: Not Yet Recruiting → Recruiting 2025-02-01
Trial Details
NCT Number NCT06449521
Lead Sponsor Possible
Collaborators: University of California, San Francisco, National Institute of Mental Health (NIMH), Ministry of Health and Population, Nepal
Conditions Mental Health Disorder, Non Communicable Diseases
Enrollment 700 participants
Start Date 2024-07-16
Primary Completion 2027-01 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-04-14