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

Background Common mental health conditions (CMHCs) such as depression and anxiety often co-occur with noncommunicable diseases (NCDs) like hypertension and diabetes, compounding disability and mortality particularly in low- and middle-income countries (LMICs), with under-resourced health systems. This comorbidity is driven by shared behavioral risk factors including stress, isolation, tobacco use, inactivity, poor diet, and nonadherence to treatment. The World Health Organization recommends evidence-based stress reduction (EBSR), behavioral activation (BA), and motivational interviewing (MI) to address these modifiable risks, but the implementation of such multi-component behavioral interventions in community-based settings remains limited. There is a critical gap in implementation research on how best to deliver these combined interventions through community health workers (CHWs) within public health systems. This study addresses that gap by evaluating the effectiveness, implementation, and scalability of the BEhavioral Community-based COmbined Intervention for MEntal health and noncommunicable diseases (BECOME). The trial assesses clinical outcomes, implementation outcomes using the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) framework at patient, provider, and health system levels and conducts a comprehensive costing analysis to inform future scale-up. Methods This is a stepped-wedge cluster randomized controlled trial involving 20 geographic clusters across two provinces of Nepal and 700 participants aged 40 years and above with at least one CMHC and one NCD. CHWs will be trained to deliver BECOME, comprising EBSR, BA, and MI, while the control period will include enhanced usual care. Primary outcomes include changes in CMHC severity and secondary outcomes include NCD outcomes, behavioral factors, and implementation processes. Focus group discussions and in-depth interviews with CHWs, patients, healthcare providers, and health system leaders will explore intervention acceptability and mechanisms of change. Structured costing analysis will estimate the intervention costs. Discussion Participant recruitment began in July 2024 and is currently ongoing. We anticipate completing data collection for the primary outcome measures by January 2027, with the aim of disseminating preliminary findings within the same year. Findings from this study will provide evidence on the effectiveness and feasibility of a CHW-delivered, integrated behavioral intervention, BECOME, for CMHCs and NCDs in LMICs, informing potential scale-up. Trial registration ClinicalTrials.gov, NCT06449521, Registered on 25 April, 2024, https://register.clinicaltrials.gov/prs/beta/studies/S000DZJN00000112/recordSummary