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

NCT06449521 | Active Not Recruiting DMC

• 2 other identifiers: BECOMEPossible1R01MH133231-01
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health Disorder; Non Communicable Diseases

Keywords

Mental Health; Non communicable Diseases

Outcome Measures

Primary Outcomes (1)

• Lower Mean Hopkins Symptom Checklist-25 (HSCL-25) score

  The Hopkins Symptom Checklist-25 is a measure of symptoms of anxiety and depression. This instrument consists of two different subscales; one for anxiety symptoms and the other for depression. The scale for each question includes four response categories ("Not at all," "A little," "Quite a bit," and "Extremely," rated 1 to 4, respectively). The scores range from 1 to 4. Higher score shows higher severity of anxiety and depression symptoms.

  First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.

Secondary Outcomes (3)

• Mean systolic blood pressure in millimeters of mercury (mmHg)

  First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.

• Mean diastolic blood pressure in millimeters of mercury (mmHg)

  First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.

• Fasting plasma glucose in milligrams per deciliter (mg/dL)

  First in baseline assessment and then every 3 months up to 12 months from the start of BECOME intervention.

Study Arms (1)

Single arm- stepped wedge implementation

OTHER

All participants enrolled in the study will receive intervention in a stepped wedge fashion. This means that every three months, four clusters will transition to the intervention phase until all clusters (a total of 20) in the study have received intervention. Participants will receive routine usual care when their clusters are in the control phase. This includes the Government of Nepal's (GoN) current protocols at the home/community level. CHWs will monitor for CMD and NCD symptoms and red flags every three months, provide health education, and refer individuals to health facilities.

Behavioral: BECOME intervention

Interventions

BECOME intervention BEHAVIORAL

The intervention, BECOME, includes: a) Evidence-based stress reduction (EBSR): as recommended in the WHO mhGAP guidelines, diaphragmatic breathing and body scan will be used to manage stress and anxiety. b) Behavioral activation (BA): as recommended in the mhGAP guidelines, this evidence-based strategy will increase the time that patients spend engaging in pleasurable activities to both treat depression and increase physical activity, depending on their cognitive and physical capabilities (e.g., going to a neighbor's house for tea or walking to the local market). c) Motivational interviewing (MI): an evidence-based patient-interaction strategy that increases the patient's internal motivation to engage in healthy behaviors (e.g., quit tobacco) both to prompt change (if they are not engaging in healthy behaviors) and maintain them (if they are already engaged in healthy behaviors), as recommended by Package of Essential Noncommunicable disease interventions) PEN protocols.

Single arm- stepped wedge implementation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Significant cognitive problems/disability
• Pregnant women
• Postpartum (≤6 weeks) women

Sponsors & Collaborators

• Possible: lead
• University of California, San Francisco: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Ministry of Health and Population, Nepal: collaborator

Study Sites (1)

Possible

Kathmandu, Nepal

Location

Related Publications (9)

• mhGAP Intervention Guide for Mental, Neurological and Substance Use Disorders in Non-Specialized Health Settings: Mental Health Gap Action Programme (mhGAP): Version 2.0. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK390828/

  PMID: 27786430 BACKGROUND

• Hettema JE, Hendricks PS. Motivational interviewing for smoking cessation: a meta-analytic review. J Consult Clin Psychol. 2010 Dec;78(6):868-84. doi: 10.1037/a0021498.

  PMID: 21114344 BACKGROUND

• Lai DT, Cahill K, Qin Y, Tang JL. Motivational interviewing for smoking cessation. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD006936. doi: 10.1002/14651858.CD006936.pub2.

  PMID: 20091612 BACKGROUND

• Li Z, Chen Q, Yan J, Liang W, Wong WCW. Effectiveness of motivational interviewing on improving Care for Patients with type 2 diabetes in China: A randomized controlled trial. BMC Health Serv Res. 2020 Jan 23;20(1):57. doi: 10.1186/s12913-019-4776-8.

  PMID: 31973759 BACKGROUND

• Heckman CJ, Egleston BL, Hofmann MT. Efficacy of motivational interviewing for smoking cessation: a systematic review and meta-analysis. Tob Control. 2010 Oct;19(5):410-6. doi: 10.1136/tc.2009.033175. Epub 2010 Jul 30.

  PMID: 20675688 BACKGROUND

• Lundahl B, Moleni T, Burke BL, Butters R, Tollefson D, Butler C, Rollnick S. Motivational interviewing in medical care settings: a systematic review and meta-analysis of randomized controlled trials. Patient Educ Couns. 2013 Nov;93(2):157-68. doi: 10.1016/j.pec.2013.07.012. Epub 2013 Aug 1.

  PMID: 24001658 BACKGROUND

• Sayegh CS, Huey SJ, Zara EJ, Jhaveri K. Follow-up treatment effects of contingency management and motivational interviewing on substance use: A meta-analysis. Psychol Addict Behav. 2017 Jun;31(4):403-414. doi: 10.1037/adb0000277. Epub 2017 Apr 24.

  PMID: 28437121 BACKGROUND

• Anthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE; Lung Health Study Research Group. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med. 2005 Feb 15;142(4):233-9. doi: 10.7326/0003-4819-142-4-200502150-00005.

  PMID: 15710956 BACKGROUND

• Sigdel K, Nepal J, Shrestha A, Rai B, Yogi B, Schillinger D, Sharma D, Prajapati D, Heylen E, Niraula HK, Shrestha J, Dhimal M, Sah NK, Baral PP, Limbu P, Nepal P, Paudel P, Nepali S, Poudel S, Joshi S, Tiwari S, Shrestha S, Sapkota S, Acharya B. A type II hybrid implementation-effectiveness study of the BECOME intervention: integrating Behavioral Community-Based Approaches for Mental Health and Non-Communicable Diseases delivered by community health workers-study protocol for a stepped wedge cluster randomized controlled trial. Trials. 2026 Jan 24;27(1):142. doi: 10.1186/s13063-026-09457-1.

  PMID: 41580851 DERIVED

MeSH Terms

Conditions

Mental Disorders; Noncommunicable Diseases; Psychological Well-Being

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Bibhav Acharya, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Sabitri Sapkota Devkota, PhD

  Possible

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is a stepped wedge cluster randomized controlled trial. Since participants will receive routine care when they are not receiving the BECOME intervention (which the investigators will randomly allocate using a stepped wedge fashion), the investigators will blind outcome assessors for the follow-up assessment every three months until 12 months of follow up post intervention. But, it's important to note that our response to masking outcome assessors cannot be recorded in above option.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will use a stepped-wedge randomized controlled trial design. Randomization process involves sequential rolling out of the intervention in four cluster every three months. Each cluster is a ward (population \~6000), which includes one CHW and at least one basic health care clinic, with regional referrals available to higher levels of care. The 20 wards will be randomly assigned (using a random number generator) to one of five steps. All clusters begin in the control condition; every three months, four clusters will transition to the intervention condition. Note: The investigators have not seen better option than this one in the drop down menu above.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: June 10, 2024
• Study Start: July 16, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Final submission and release of the study data will occur approximately 12 months following the end of the trial, and within the award period. Study data deposited in the repository will be available to the research community in perpetuity. Datasets underlying methodological publications will be shared at or prior to initial publication date.
• Access Criteria: The investigators will share ONLY the deidentified data through NIH designated data repositories consistent with data sharing under the NIH GDS policy. The investigators will include the clinical data of those research participants who will provide consent for sharing their data.

Locations

NE (1)