Combined intervention for mental health and noncommunicable diseases in Nepal
A Type II Hybrid Implementation-effectiveness Study of BECOME (BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases) Delivered by Community Health Workers in Nepal
This study tests a new program in Nepal that helps people with mental health issues and chronic diseases like diabetes and high blood pressure to see if it can improve their overall health and well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Possible Academic / other |
| Locations | 1 site (Kathmandu) |
| Trial ID | NCT06449521 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness and implementation of the BECOME program, which addresses common mental health disorders and noncommunicable diseases in Nepal. The program utilizes a stepped-wedge cluster randomized trial design to assess its impact on depression, anxiety, diabetes, and hypertension. It also examines implementation outcomes using the RE-AIM framework and includes a comprehensive costing analysis for future scalability. The intervention is delivered by community health workers to ensure accessibility in resource-limited settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40 years or older who experience anxiety or depression and have at least one noncommunicable disease.
Not a fit: Patients with significant cognitive problems, disabilities, or those who are pregnant or postpartum may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mental health and reduce the burden of noncommunicable diseases among participants.
How similar studies have performed: Other studies have shown success with similar behavioral interventions in addressing mental health and noncommunicable diseases, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult men and women age ≥ 40 years * Living in the target wards with no intention of leaving in the next 2.5 yrs * Anxiety (HSCL-25 anxiety subscale score ≥1.75) and/or Depression (HSCL-25 depression subscale score ≥1.75) * At least one Non-communicable disease (NCD) based on WHO PEN criteria; either Hypertension (HTN) (SBP ≥130mmHg and/or DBP ≥80mmHg) and/or Diabetes Mellitus (DM) (fasting plasma glucose (FPG) ≥126mg/dl or random plasma glucose ≥200mg/dl) Exclusion Criteria: * Significant cognitive problems/disability * Pregnant women * Postpartum (≤6 weeks) women
Where this trial is running
Kathmandu
- Possible — Kathmandu, Nepal (Recruiting)
Study contacts
- Principal investigator: Bibhav Acharya, MD — University of California, San Francisco
- Study coordinator: Bibhav Acharya, MD
- Email: Bibhav.Acharya@ucsf.edu
- Phone: +1 917 653 9385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.