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

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 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article 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trial Kripa Sigdel, Jyoti Nepal, Archana Shrestha, Bala Rai, Bhawani Yogi, and 19 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7065341/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 24 Jan, 2026 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract 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 Implementation research behavioral intervention mental health Non-communicable diseases community health workers Nepal Figures Figure 1 Figure 2 Introduction Common mental health conditions (CMHCs), such as depression and anxiety, are the leading causes of disability worldwide [ 1 ]. Non-communicable diseases (NCDs) like hypertension (HTN) and diabetes mellitus (DM) cause 75% of deaths annually, with 82% occurring in low- and middle-income countries (LMICs) [ 2 ]. In LMICs, up to 70% of individuals with CMHCs receive no care [ 3 ], and treatment for HTN and DM is often inadequate [ 4 ]. In Nepal, the study setting, HTN and DM are the primary causes of mortality [ 4 , 5 ], while CMHCs are the leading contributors to disability [ 6 , 7 ]. CMHCs frequently co-occur with NCDs [ 8 , 9 ], with mental health symptoms reported by 30–32% of individuals with HTN or DM [ 10 , 11 ]. Shared behavioral risk factors such as stress, social isolation, tobacco use, low physical activity, poor diet, and medication non-adherence contribute to both conditions leading to morbidity and mortality [ 12 – 17 ]. Moreover, untreated CMHCs can worsen NCD outcomes and vice versa, underscoring the need for integrated approaches to care [ 18 , 19 ]. To address this gap, the World Health Organization (WHO) has developed clinical guidelines for non-specialist providers, including the mental health Gap Action Program (mhGAP) Intervention Guide [ 20 ], and the Package of Essential Non-communicable Disease Interventions (PEN) [ 21 , 22 ]. Both protocols recommend behavioral interventions such as evidence-based stress reduction (EBSR) [ 23 – 26 ], behavioral activation (BA) [ 27 , 28 ], and motivational interviewing (MI) [ 29 – 31 ]. These low-cost, scalable techniques are suitable for delivery by non-specialists, including primary care providers and community health workers (CHWs) [ 32 , 34 ]. The unreliable medication supply chain in many LMICs [ 35 ], further underscores the need for behavioral interventions, which are time-limited, cost-effective, and acceptable to patients [ 36 , 37 ]. Few studies have tested integrated behavioral interventions addressing both CMHCs and NCDs concurrently [ 38 , 39 ]. However, behavioral care remains underutilized. In Nepal, most patients receive medications alone, with few accessing therapy [ 40 – 43 ]. Primary Care Providers (PCPs) often lack training in evidence-based techniques, relying instead on educational or judgmental approaches [ 44 , 45 ]. Patients, however, frequently prefer counseling to medications [ 36 , 43 , 46 ]. National data also highlight high rates of behavioral risks such as tobacco use, poor diet, and medication non-adherence indicating an urgent need for behavioral interventions [ 47 , 48 ]. Clinic-based delivery of such interventions is constrained by short visit times and limited staffing [ 49 , 50 ]. CHWs, embedded within communities and already central to health outreach in Nepal and other LMICs [ 51 – 55 ], offer a more practical solution. Evidence shows CHWs can effectively deliver EBSR [ 56 ], BA [ 57 ], MI [ 29 ], and NCD-related counseling [ 58 – 60 ]. Our prior work in Nepal [ 61 – 63 ], and research by others [ 64 , 65 ], demonstrates that CHWs can effectively deliver culturally adapted behavioral interventions for both CMHCs and NCDs. Yet two gaps persist: First, most CHW interventions target one or two conditions rather than coexisting CMHCs and NCDs [ 66 , 67 ]. For example, combining EBSR with MI could better support tobacco cessation if stress is a barrier [ 68 ], and pairing BA with MI could address isolation and inactivity synergistically [ 69 , 70 ]. Second, CHWs face implementation barriers requiring strategies at the CHW level (ongoing skill support) [ 71 , 72 ], interpersonal level (support from patients and PCPs) [ 73 , 74 ], and system level (funding and leadership) [ 75 – 77 ]. To address these gaps, we propose BECOME (Behavioral Community-based COmbined Intervention for MEntal Health and NCDs) an integrated, CHW-delivered home-based intervention combining EBSR, BA, and MI. We have previously piloted its components and tested strategies to support CHW skills, provider and patient engagement, and system-level adoption [ 62 , 63 ]. A robust evaluation is now needed to assess both effectiveness and implementation of BECOME in LMIC settings. This paper presents a novel methodology that employs a community-based, stepped-wedge cluster randomized controlled trial (SWCRT) to conduct this evaluation. This study has three objectives: Aim 1 is to assess BECOME effectiveness on depression, anxiety, diabetes, and hypertension using a SWCRT design. Aim 2 is to evaluate implementation outcomes via the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework at patient, provider, and health system levels. Aim 3 is to conduct a comprehensive costing analysis to provide strategic economic insights supporting long-term BECOME scale-up. Methods Study Design This is a type-II hybrid implementation-effectiveness study, assessing both effectiveness and implementation where we employ a SWCRT design, with cluster-level randomization stratified by municipality. Each cluster (a ward of ~ 6,000 people) includes a basic healthcare clinic and is served by one CHW, minimizing contamination risk. The 20 clusters are randomized into five steps using a random number generator, transitioning from control to intervention every three months in groups of four (Fig. 1 ). Participants in each cluster will be followed up for 12 months after the completion of the intervention. SWCRT is suitable as Government of Nepal (GoN) partners want BECOME deployed across all clusters during the study, and the small number of clusters in GoN’s new CHW pilot program aligns well with this design. An open cohort model [ 78 – 80 ], is preferred to mimic real-world conditions, support scale-up, maintain target participation during intervention phases, and address attrition or eligibility changes, especially common in CMHCs and NCDs [ 81 , 82 ]. Figure 1 . Stepped-wedge schedule for 20 clusters with quarterly follow-ups during intervention rollout. Study Setting The study is being conducted in two municipalities in Nepal, Chandragiri and Bardibas, selected for their socio-economic and geographic diversity, as well as their alignment with GoN’s pilot CHW program. Chandragiri, located in the hilly Bagmati Province, has a population of 136,860 with a literacy rate of 87.3% and a provincial Human Development Index (HDI) of 0.652 [ 83 , 84 ]. Bardibas, in the plains of Madhesh Province, has a population of 74,361 and a literacy rate of 72.5% with an HDI of 0.561 [ 83 , 84 ]. These municipalities represent both urbanizing and semi-rural areas, making them ideal for evaluating scalable, community-based health interventions across diverse populations. The CHW program employs salaried, licensed CHWs with three years of clinical training (proficiency certificate in nursing) and mobile tools [ 85 , 86 ]. We focus on CHWs due to GoN’s priority and MI’s reliance on clinical skills [ 29 ]. The intervention is supported by Possible, a non-profit organization focused on innovation and research [ 87 ]. Study Population and Eligibility Criteria Patient Participants must be adult men/women aged ≥ 40 years residing in study clusters with no plans to relocate within 2.5 years. Eligible individuals must meet criteria for anxiety and/or depression (Hopkins Symptoms Checklist, HSCL-25, subscale ≥ 1.75) and have hypertension (systolic blood pressure-SBP ≥ 130 mm Hg or diastolic blood pressure-DBP ≥ 80mm Hg) or diabetes (fasting blood glucose-FBG ≥ 126 mg/dl or random blood glucose ≥ 200 mg/dl). These criteria ensure inclusion of individuals with both CMHCs and NCDs. Individuals with significant cognitive impairment, disabling conditions, or pregnancy/postpartum status (≤ 6 weeks) are excluded due to differing care needs. Excluded patients are referred to higher-level care. Those reporting suicidalities are assessed, linked to crisis services, and re-approached for eligibility after stabilization. CHWs must be actively working in the government pilot community health program (CHP) and trained in the BECOME intervention. No specific exclusion criteria apply to this group. Eligible PCPs must be currently working in health facilities within the catchment areas. They must be willing to participate either in training alone or in both training and the study. We exclude those absent from health facilities within the catchment area during the study period. Health System Leaders (HSLs) include supervisors of CHWs, health coordinators from municipal offices within the catchment area, and elected representatives serving their term during the study period who are familiar with CHP. Additionally, other stakeholders who contributed to the design and implementation of CHP are eligible. We exclude those who are absent in the catchment area during the study period. Randomization and Blinding The first step in the cluster randomization process is to identify the 20 clusters to be randomized from among the 14 and 15 clusters in the Bardibas and Chandragiri municipalities, respectively. We randomly select ten clusters from each municipality in the presence of Community Advisory Board (CAB) members to ensure transparency. Next, we randomly select four clusters for implementation of the BECOME intervention every three months. We video-record each randomization step to ensure transparency. We begin the initial household screening in the home located closest to the geographic center of the cluster. We then carry out subsequent screenings in the nearest neighboring household to the one previously screened, continuing this process until we recruit 35 eligible participants. We blind the assessment staff (Research Outcome Assessors, ROAs) by restricting their access to intervention materials, using unidentifiable ID numbers, preventing communication between CHWs and ROAs, and scheduling them to work at different times. If any accidental disclosures of cluster allocation occur, we document and address them within the study team and include them in the study analysis. At the end of the study, we plan to conduct qualitative interviews with all ROAs to document any such disclosures. Sample Size and Power Calculations Power calculations assume 30 patient participants per cluster across 20 clusters over 18 months, with a SWCRT design involving five steps and six periods (Fig. 1 ). Anticipating some participants will regress to the mean and become ineligible, we will recruit 700 patients. Patients in the last four clusters to transition will be followed until month 30. Using the National Institute of health (NIH) SWCRT sample size calculator [ 88 ], we estimated minimum detectable effect sizes with α = 0.05, 80% power, and correlations: ICC = 0.2 [ 89 ], CAC = 0.7 [ 90 ], and IAC = 0.6 [ 81 ]. The attrition rate is set at 0.5 due to expected withdrawal, relocation, or ineligibility at treatment start, with up to 30% ineligibility for CMHCs [ 79 , 81 , 82 ]. These assumptions yield a standardized minimum detectable effect size of 0.34 about 1/3 SD on HSCL-25 indicating a small-to-medium effect [ 91 ]. Of 700 patient participants, 30 will complete in-depth interviews (IDIs) at three and 12 months to explore engagement barriers and facilitators. Ten focus group discussions (FGDs) with CHWs will assess intervention delivery, mHealth use, supervision, and support. Five PCPs and six health system leaders will participate in key informant interviews (KIIs) at similar intervals to explore CHW collaboration, perceived feasibility, and system-level support for BECOME scale-up and sustainability. Recruitment and Data Collection We base the sampling frame on the GoN’s pilot CHP list and further validate and expand it using data from private health facilities and nonprofits. Among the 40,000 individuals aged ≥ 40 years in the 20 clusters, we estimate that 10% have at least one CMHC [ 92 ], or target NCD [ 93 ], ensuring a sufficient pool to maintain at least 35 participants per cluster per measurement period. Research staff develop the sampling framework in coordination with CHWs and municipal stakeholders. Screening begins at the household nearest to the cluster’s geographical center and continues to adjacent homes until we enroll 35 eligible participants per cluster. Eligible participants provide written informed consent and complete baseline assessments via Research Electronic Data Capture (REDCap). ROAs, blinded to allocation, conduct 45 to 60-minute face-to-face interviews in private settings every 3 months for one year following the intervention. We train and supervise ROAs to ensure interview quality, reduce bias, and protect participant confidentiality; and we provide a small financial incentive to participants. The qualitative team will conduct FGDs with CHWs and IDIs and KIIs with patient participants, PCPs, and HSLs. Enhanced Usual Care Participants receive Enhanced Usual Care (EUC) following GoN protocols [ 86 ] in all the clusters. CHWs and PCPs receive targeted training on referral criteria and basic CMHC and NCD education. CHWs monitor symptoms and red flags every three months, provide health education, and refer patients as needed. PCPs at health posts conduct screening, monitor patients, provide lifestyle education, and prescribe/refill medications based on WHO’s mhGAP [ 20 ], and PEN protocols [ 21 ]. They also refer patients to higher-level care when necessary. Intervention Components EBSR Involves diaphragmatic breathing and body scan techniques to manage stress and anxiety, recommended by WHO [ 20 ]. Delivered by trained CHWs over two weeks, each 20 to 30 minute session includes instruction, demonstration, participant practice, feedback, and home practice assignments. Deep breathing is provided to all except those with respiratory issues, who receive body scan exercises. Culturally adapted materials and fidelity checklists exist [ 61 ]. BA Encourages engagement in pleasurable and meaningful activities to reduce depression and increase physical activity. Offered over two weeks in 20 to 30 minute sessions to patients with depression, BA supports mood improvement and active lifestyles. Training materials and fidelity checklists are available [ 61 , 94 , 95 ]. MI A theory driven counseling method to strengthen motivation for behavior change (e.g., tobacco cessation, nutrition), recommended by WHO PEN protocols [ 21 , 22 ]. Delivered in four sessions, MI helps participants explore progress and overcome barriers. Adapted manuals and fidelity checklists are available [ 61 , 94 ]. Delivery and Duration The 6–8 weeks intervention includes weekly 20 to 30 minute CHW home visits. All receive four weeks of MI. Patients with one CMHC (anxiety or depression) receive two weeks of EBSR or BA; those with two CMHCs receive four weeks of both (Table 1 ). Participants who explicitly decline or choose to discontinue the intervention sessions, as well as those who become ineligible to participate in the study due to their health conditions, will be withdrawn from further session delivery after discussion in the study team. CHWs will refer these individuals to appropriate health facilities for further care, and they will continue to receive all other routine health services available within the community. Table 1 Timeline of the BECOME Intervention components. Timeline​ BECOME components​ Intervention target​ Weeks: 1 and 2 ​ (20–30 minutes each) Evidence Based Stress Reduction ​ (Deep breathing or Body Scan) ​ Anxiety and stress management​ Weeks: 3–4 ​ (20–30 minutes each) Behavioral Activation​ Depression​ Weeks: 5–8 ​ (20–30 minutes each) Motivational Interviewing​ a NCD ( b HTN and/or c DM) targeting behavior change or maintenance ​ a NCD: Non-communicable disease; b HTN: Hypertension; c DM: Diabetes Mellitus Retention To improve retention, we leverage CHWs who have strong local networks and familiarity with households. ROAs verify and update participant contact information at each assessment. If participants are unreachable, ROAs follow a 14-day structured outreach protocol, including calls and home visits. The study team reaches out to CHWs for support if needed. Regular CHW visits for health surveillance are routine and unlikely to cause stigma. Quarterly CAB meetings serve as a source of guidance and provide independent feedback and critique to strengthen the research process that is respectful of, acceptable to, and responsive to the community. Outcomes for Aim 1 The primary outcome measure is CMHC severity, measured by mean HSCL-25 score collected at 3-month intervals, alongside all other measures. Secondary measures include mean SBP and DBP for HTN, and mean FBG for DM. Behavioral measures include tobacco use, physical activity, diet quality, medication adherence, and adherence to follow-up (Table 2 ). Table 2 Key model variables and associated components (collected quarterly except demographics). Key model variables Description of scales Intervention components Demographics Age, education, languages spoken, religion, income, and caste Depression, Anxiety Primary outcome Hopkins Symptom Checklist (HSCL-25) includes depression and anxiety subscales on a 4-point like scale validated and used locally in Nepal. a EBSR for anxiety b BA for depression d NCD outcomes Secondary outcomes Mean systolic blood pressure (SBP), diastolic blood pressure (DBP), and fasting plasma glucose, measured by research staff with manual cuff and point of care test. c MI for all behavioral targets Isolation and withdrawal Behavioral Activation for Depression Scale (BADS-SF) 9-items to assess withdrawal from or engagement in rewarding activities, adapted by our team. BA for isolation and depression Quality of life WHO Quality of Life (WHOQOL) 26 items on physical health, psychological well-being and social functioning; validated in Nepal. All intervention components EBSR, BA, MI Tobacco use 4 questions from Global Adult Tobacco Survey (GATS) to assess current and past smoked or smokeless tobacco use, quit attempts and intention to quit; used in Nepal. MI for tobacco avoidance Diet quality Diet Quality Questionnaire (DQQ) Binary questions about food groups (29 items) consumed in the previous day; adapted in many countries, including Nepal. MI for improving and maintaining diet quality Physical activity Global Physical Activity Questionnaire (GPAQ) 16 items to assess physical activity in work, travel and leisure; used in Nepal’s national survey. MI for improving and maintaining physical activity Medication adherence 4 day recall for medication adherence, adapted by our team in MI studies in Nepal, < 90% considered low adherence, based on current literature. MI for medication adherence Regular clinic follow-up Missed a scheduled follow-up clinic visit in 2 weeks or more used by our team in current MI studies in Nepal. MI for regular clinic follow up a EBSR: Evidenced Based Stress Reduction; b BA: Behavioral Activation; c MI: Motivational Interviewing; d NCD: Non-communicable disease Outcomes and Implementation Strategies for Aim 2 To ensure sustainable implementation in real-world settings, we use three implementation strategies developed using the COM-B framework, which addresses Capability (the individual’s psychological and physical capacity to engage in the behavior), Opportunity (external factors that make the behavior possible or prompt it), and Motivation (internal processes influencing behavior) to achieve CHWs delivering BECOME effectively [ 96 ]. These strategies operate at intrapersonal, interpersonal, and health system levels. Implementation outcomes are assessed via the RE-AIM framework [ 97 ]. Strategy 1: mHealth App to enhance fidelity (Intrapersonal Level) Maintaining fidelity is critical, as CHWs often revert to advice-giving instead of evidence-based techniques [ 71 ]. A decision support app tested with 30 CHWs in a pilot study [ 94 ], provides real-time guidance and audio recordings for supervisor feedback. Acceptability was high: 94% found it helpful, and 100% adopted it. Impact is measured via app usage, CHW FGDs, and fidelity scores (≥ 80% on BECOME checklist). Strategy 2: CHWs training PCPs to improve attitudes (Interpersonal Level) Negative attitudes toward behavioral interventions among PCPs and patients can hinder adoption [ 73 , 74 ]. Training PCPs in stress-relief techniques like EBSR and BA improves their attitudes and willingness to recommend these interventions [ 98 ]. Co-delivery of training by CHWs and mental health specialists enhances CHWs’ credibility and PCP engagement, aligning with the COM-B framework [ 96 , 99 ]. Measurements include pre/post attitude surveys, patient interviews, intervention reach, and quarterly perception surveys. Strategy 3: Interdisciplinary case conferences (ICCs) to highlight CHWs’ impact (Health System Level) Limited recognition of CHWs is a barrier to sustainability [ 67 ]. ICCs, where CHWs and PCPs present cases together, improve health leaders’ perceptions [ 96 ]. ICCs are integrated into biannual health leader meetings, with pre/post surveys and CHW support and maintenance tracked at 12 months. Outcomes for Aim 3 Aim 3 supports policymakers in evaluating BECOME for scale-up by estimating average costs per beneficiary per CHW, analyzing cost variation across clusters and patient profiles, and assessing resource needs for scaling the implementation strategies. Data Management and Analysis Plan ROAs collect data from the assessment tools (Table 2 ) using encrypted, password-protected tablets with the REDCap mobile app. Staff store data securely on devices until they upload it to a secure server. They store all identifying information such as consent forms and contact logs separately under lock and key. Staff do not store identifying information on the same devices or in the same locations as study data. CHWs record intervention sessions on encrypted, password-protected phones already used for patient data collection. They review audio recordings privately with research counselors for supervision and feedback. The research team randomly selects at least one recording per CHW for fidelity review using BECOME fidelity rating scale adapted from WHO’s Ensuring Quality in Psychological Support (EQUIP) platform. Only two authorized team members access these recordings, which they store temporarily on an encrypted, password-protected laptop and delete after review. A data manager, supervised by the senior statistician review study data monthly to monitor completeness, accuracy, protocol adherence, and participant safety. For Aim 1, we will use generalized linear mixed models to evaluate the BECOME intervention’s impact on HSCL-25 scores, applying an intention-to-treat approach. Continuous outcomes will use a normal distribution with an identity link, with fixed effects for secular and intervention trends and random effects for individual, cluster, and time-level variability. The intervention effect will include a constant term and a treatment-by-time interaction, with random intercepts for participants and clusters. This method will also assess secondary outcomes (e.g., FBG, SBP, DBP). Binary outcomes (e.g., optimal adherence) will apply the same model structure with a Bernoulli distribution and logit link. Structural Equation Modeling will further explore direct, indirect, and synergistic effects of intervention components via mediators (Fig. 2 ). Figure 2 . Conceptual model to improve CMHCs and NCDs using EBSR, BA, MI, and implementation strategies. CMHCs: Common Mental Health Conditions; NCDs: Non-communicable Diseases; CHW: Community Health Worker; HSCL-Hopkins Symptom Checklist Aim 2 involves a mixed-methods evaluation of implementation mechanisms using surveys and 71 in-depth interviews (30 patients-2 times, six leaders, five PCPs) and 10 FGDs, coded thematically in Dedoose. A preliminary codebook will be refined collaboratively, ensuring ≥ 80% intercoder reliability. Memos will explore links among strategies, mechanisms, and outcomes. Additionally, CHW app usage data will be passively collected via the Community Health Toolkit, integrated into daily workflows without adding burden to CHWs. Costing Analysis Plan for Aim 3 Aim 3 uses programmatic and financial data to conduct a comprehensive cost analysis of delivering BECOME. Costing will use a bottom-up (micro-costing) approach at the beneficiary level, calculating total cost per CHW visit and deriving average intervention costs, including its components [ 100 ]. Both recurrent costs and capital cost depreciation will be measured using Time-Defined Activity-Based Costing (TDABC), which details resource use across care delivery [ 101 – 104 ]. Data sources include CHW time logs, CHW surveys on indirect resource use, researcher records of CHW, PCP training and ICC, along with financial records from municipalities and the BECOME team. CHW services are funded through municipal budgets under the Government of Nepal’s CHW program. Prior costing from a similar rural CHW program in Nepal [ 105 ], informs our methods. The analysis will disaggregate costs by intervention component (EBSR, BA, MI) and function (patient care, supervision, data monitoring, administration), and detail start-up costs and cost heterogeneity by cluster and patient characteristics such as comorbidities and behavioral goals. Participant Safety, Adverse Event Management and Data Monitoring The Co-Principal Investigators (Co-PIs) supervise the study directly, with the site Principal Investigator (PI) and the research project manager overseeing daily operations. Co-Investigators and domain-specific experts provide additional guidance and monitoring. All team members complete training in research ethics and human subject’s protection and sign a confidentiality agreement before initiating any participant interaction. The study team actively safeguards the safety and confidentiality of all participants during assessments and intervention. If a participant shows signs of ongoing distress despite CHW-delivered support, displays red flags per mhGAP or PEN protocols, or requests higher-intensity care for CMHCs or NCDs, the team refers them according to the referral pathway to the nearby hospitals. When ROAs identify any participant at high or acute risk of suicide, they follow the crisis management pathway and immediately connect them with a contracted crisis counselor for evaluation and support. If they require urgent intervention, the team coordinates with their emergency contact and refers them to a nearby tertiary care facility. If no immediate referral is needed, ROAs provide the participant with a resource card listing relevant support services. In both cases, a study team member and the crisis counselor follow up within 48 hours to ensure the participant’s safety and well-being. All study staff report adverse events including breaches of confidentiality to the research project manager, who escalates them to the site PI. The team documents all adverse events in an Adverse Event Summary Log and attaches them to the Continuing Review or Study Closeout Forms, following each Institutional Review Board (IRB)’s reporting guidelines. For serious adverse events, the research coordinator immediately notifies the site PI, who then informs the IRB of the Nepal Health Research Council (NHRC) within 48 hours and submit a detailed report within two weeks. We also conduct interim analyses between follow-up assessments to monitor changes in CMHCs and NCD severity, ensuring no unintended increases occur. We also document all adverse and serious adverse events to protect participant safety and evaluate any potential risks associated with the BECOME intervention. An independent Data Safety and Monitoring Board (DSMB) oversees participant protection throughout the study. The board includes five experts in CMHCs, NCDs, biostatistics, and community-based research, and meets semi-annually (virtually or in person). The Co-PIs prepare and submit detailed reports for each meeting. The DSMB reviews participant safety protocols, confidentiality protections, and all adverse event reports. In the case of a serious adverse event, the DSMB chair may call an ad hoc meeting. The board may request additional information as needed. DSMB reports are shared with the Co-PIs and all participating IRBs to ensure transparency and accountability. Trial Quality Control and Auditing The site Principal Investigator and Research Project Manager conduct weekly reviews to monitor study implementation and monthly reviews to assess recruitment, retention, participant safety, and any methodological issues. We submit biannual recruitment and performance progress reports to the National Institute of Mental Health (NIMH) and undergo annual continuing ethical review by both the NHRC and the University of California, San Francisco. Our Nepal–US research team ensures structured implementation through pilot-tested manuals that standardize data collection and intervention delivery. CHWs complete competency-based certification using the BECOME fidelity checklist, and research staff receive training to meet performance standards. We re-train any staff who do not meet benchmarks before certification to maintain intervention quality. Monthly investigator calls, quarterly steering committee and implementation research committee meetings facilitate communication, coordination, and oversight, supporting consistent progress and collaborative management of the trial. We used SPIRIT reporting guidelines to report this protocol [ 106 ]. Dissemination Plan We plan to actively disseminate study findings to inform public health policy, community programs, and future research. The results contribute to the development of integrated behavioral interventions for CMHCs and NCDs and offer a model for implementation in Nepal and similar low-resource settings. We plan to share findings with public health officials, regional and national policymakers, hospital administrators, non-governmental organizations, community members, and the international academic community. Dissemination efforts include submitting manuscripts to peer-reviewed journals, presenting at conferences, and organizing a dissemination meeting in Kathmandu in Year five to directly engage stakeholders. We also plan to develop policy briefs and fact sheets to summarize key findings and recommendations, ensuring broad access and practical use of the study outcomes. Following the current NIH- Data Management and Sharing Policy, we will submit de-identified quantitative participant-level data to the NIMH Data Archive within one year of study completion. At the time of publication, we will also share the corresponding statistical analysis code and codebooks for any qualitative data included in published findings. Discussion This study addresses a critical gap in the integrated management of co-occurring CMHCs and NCDs in low- and middle-income countries LMICs, where fragmented care, stigma, and limited resources hinder effective service delivery. By training and mobilizing CHWs to deliver evidence-based behavioral interventions-EBSR, BA, and MI, the study leverages a scalable, task-shifted approach to bridge mental and physical health care in community settings. Delivering these interventions directly to patients’ homes addresses structural barriers such as transportation costs, stigma associated with facility-based mental health care, and limited clinic capacity. This decentralized, community-based model enhances accessibility and feasibility, particularly in rural and under-resourced areas like Nepal. The SWCRT design offers a rigorous framework for evaluating both effectiveness and implementation while ensuring that all clusters eventually receive the intervention, addressing ethical concerns related to withholding care. The study employs implementation strategies grounded in the COM-B model, which allows for systematic identification and mitigation of barriers to delivery. It also integrates the RE-AIM framework to assess multilevel implementation outcomes at the individual, provider, and system levels, enhancing the potential for generalizability and real-world translation. In addition to evaluating clinical and behavioral outcomes including depression and anxiety symptom reduction, improved medication adherence, tobacco cessation, and physical activity the study includes a detailed costing analysis using the TDABC approach. This will enable policymakers to understand the financial implications of scaling up the intervention within the public health system and inform decisions on sustainability, resource allocation, and integration into existing service delivery platforms. Despite inherent challenges, including the need to maintain intervention fidelity and mitigate participant attrition, the study incorporates multiple quality assurance mechanisms. These include standardized training and certification of CHWs using the BECOME fidelity checklist, ongoing supervision, and performance monitoring. The trial’s embedding within government-run pilot community health program and its alignment with existing Ministry of Health and Population structures enhance feasibility, acceptability, and the likelihood of long-term adoption. Although the intervention’s short duration may limit measurable impact on long-term NCD outcomes such as blood pressure or glycemic control, the study prioritizes early behavioral indicators and intermediate outcomes. These outcomes are predictive of improved clinical trajectories and align with WHO PEN and mhGAP guidelines. In addition, the study incorporates contingency planning for potential challenges, including alternative recruitment strategies and the replacement of inactive clusters. With adequate statistical power to detect medium effect sizes even with a limited number of clusters, the study maintains scientific rigor while ensuring practical feasibility. Successful implementation within GoN health clusters will not only facilitate potential national scale-up but also generate critical implementation insights relevant to similar LMIC contexts seeking to integrate mental and physical health care through community-based platforms. Trial Status This protocol version is 1.0 dated 14 June, 2024. 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. The detailed schedule of enrollment, intervention and assessments is presented in Table 3 . Table 3 Schedule of enrollment, interventions, and assessments. Study Period TIMEPOINT Year 1 Year 2 Year 3 Year 4 and 5 1 2 3 4 5 6 7 8 9 10 Months 1–3 4–6 7–9 10–12 13–15 16–18 19–21 22–24 25–27 28–30 Preparation phase (develop protocol, hire/train staffs, etc.) X Allocation Random allocation of 20 clusters (10 clusters from each site) X Random allocation of 4 clusters per each intervention phase X X X X X Enrollment Eligibility Screening X X X X X Informed consent X X X X X Intervention Training of interventionists and intervention delivery (4 clusters receive intervention at each intervention phase) X (cluster 1–4) X (cluster 5–8) X (cluster 9–12) X (cluster 13–16) X (cluster 17–20) Enhanced usual care (in remaining unselected clusters) X X X X X Assessments Baseline X X X X X Follow up X X X X X X X X X Analysis of : Primary and secondary outcomes X Implementation outcomes X Cost-effectiveness X Abbreviations BA Behavioral Activation BADS Behavioral Activation for Depression Scale BECOME Behavioral Community-based Combined Intervention for Mental Health and Non-communicable Disease CAB Community Advisory Board CHP Community Health Program CHW Community Health Worker CMHCs Common Mental Health Conditions COM-B capability (C), opportunity (O) and motivation (M) are essential for any behavior (B) to change Co-PI Co-Principal Investigator DBP Diastolic Blood Pressure DM Diabetes Mellitus DQQ Diet Quality Questionnaire DSMB Data Safety and Monitoring Board EBSR Evidence Based Stress Reduction EUC Enhanced Usual Care FBG Fasting Blood Glucose FGDs Focus group discussions GATS Global Adult Tobacco Survey GoN Government of Nepal GPAQ Global Physical Activity Questionnaire HDI Human Development Index HSCL Hopkins Symptom Checklist HSL Health System Leaders HTN Hypertension ICC Interdisciplinary Case Conference IDIs In-depth Interviews IRB Institutional Review Board KIIs Key Informant Interviews LMICs Lower Middle-Income Countries mhGAP mental health Gap Action Program MI Motivational Interviewing NCDs Non-communicable diseases NHRC Nepal Health Research Council NIH National Institute of Health NIMH National Institute of Mental Health PCPs Primary Care Providers PEN Package of Essential Non-communicable Disease Interventions PI Principal Investigator RE-AIM Reach, Effectiveness, Adoption, Implementation, and Maintenance REDCap Research Electronic Data Capture ROAs Research Outcome Assessors SBP Systolic Blood Pressure SWCRT Stepped-wedge cluster randomized controlled trial TDABC Time-Defined Activity-Based Costing WHO World Health Organization WHO EQUIP WHO Ensuring Quality in Psychological Support WHO QOL WHO Quality of life Declarations Ethical approval and consent to participate The ethical approval for the study is obtained from institutional review boards of both University of California, San Francisco (IRB #22-38288) on 04/06/2023 and Nepal Health Research Council (registration #256/2023) on 07/13/2023. The trained ROAs obtain written informed consent from all participants prior to enrollment, and verbal consent before follow up assessments, including IDIs. Any amendments to the trial protocol are communicated to the relevant ethical/institutional review boards, participants and members of the data safety and monitoring board. Consent for publication Not Applicable. We will provide the model consent form upon request. Funding This research is supported by the National Institute of Mental Health of the National Institutes of Health under Award Number R01MH133231. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The study funder or sponsor doesn’t have any direct role in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. Authors’ contributions BA and Sabitri S are the senior authors who conceived the research idea. BA, Sabitri S, Srijana S, KS (first author), AS, BR, HKN, Dean S, EH, MD, PPB and DP contributed to the design of the study. PN contributed to the costing analysis plan. KS, Srijana S, BA, and PL developed the BECOME training manual. Dikshya S, SN, SJ, ST, PP, NKS, JS and JN developed the questionnaires and interview guides. SP, BY, JN, KS, PL and Dikshya S contributed to the mHealth tool development. KS and JN drafted the manuscript. All authors read and approved the final manuscript. All authors declare that they have no competing financial interests. Acknowledgements We extend our sincere gratitude to the study participants and their families. We also acknowledge the support of local stakeholders in Bardibas and Chandragiri municipalities for facilitating the implementation of this research. Our appreciation extends to the Ministry of Health and Population, the Nursing and Social Security Division, Epidemiology and Disease Control Division, and the members of the Implementation Research Committee and Community Advisory Board for their guidance, support, and constructive feedback throughout the study. Availability of data and materials We will submit de-identified participant-level data to the NIMH Data Archive. Alongside the dissemination of study findings, we will make all associated statistical code publicly available to ensure transparency and reproducibility. Competing interests The authors declare that they have no competing interests. References GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022;9(2):137–50. IHME. Global Burden of Disease Collaborative Network. 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Global Health: Sci Pract. 2020;8(2):239–55. Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586. Supplementary Files SPIRITchecklistBECOME.docx Cite Share Download PDF Status: Published Journal Publication published 24 Jan, 2026 Read the published version in Trials → Version 1 posted Editorial decision: Accept 12 Jan, 2026 Reviewers agreed at journal 06 Oct, 2025 Reviewers invited by journal 06 Oct, 2025 Editor assigned by journal 12 Jul, 2025 First submitted to journal 07 Jul, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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06:42:09","extension":"html","order_by":17,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":273006,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7065341/v1/c4f9b1a62afa52bfa3fd58f2.html"},{"id":93826630,"identity":"8cd58318-7ff6-4c51-95e3-7b9dbc6538b5","added_by":"auto","created_at":"2025-10-18 06:42:08","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":345374,"visible":true,"origin":"","legend":"\u003cp\u003eStepped-wedge schedule for 20 clusters with quarterly follow-ups during intervention rollout.\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7065341/v1/7a8025ee42515c0d4866ed2e.jpeg"},{"id":93826109,"identity":"6f068604-32fc-4f74-b132-55a8a68e1ad1","added_by":"auto","created_at":"2025-10-18 06:34:08","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":186568,"visible":true,"origin":"","legend":"\u003cp\u003eConceptual model to improve CMHCs and NCDs using EBSR, BA, MI, and implementation strategies.\u003c/p\u003e\n\u003cp\u003eCMHCs: Common Mental Health Conditions; NCDs: Non-communicable Diseases; CHW: Community Health Worker; HSCL-Hopkins Symptom Checklist\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-7065341/v1/8385279097e387fa093f5076.png"},{"id":101151908,"identity":"71b805be-7cb2-4099-9012-5f319c261b5f","added_by":"auto","created_at":"2026-01-26 16:07:47","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1735478,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7065341/v1/97d43eef-bf0e-4fc8-b0da-e27dfd64d70e.pdf"},{"id":93826111,"identity":"fccdb08c-c6cf-40af-a094-1a58b6ccb22d","added_by":"auto","created_at":"2025-10-18 06:34:08","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":26946,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITchecklistBECOME.docx","url":"https://assets-eu.researchsquare.com/files/rs-7065341/v1/dc2857be5093f59ba476458e.docx"}],"financialInterests":"","formattedTitle":"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","fulltext":[{"header":"Introduction","content":"\u003cp\u003eCommon mental health conditions (CMHCs), such as depression and anxiety, are the leading causes of disability worldwide [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Non-communicable diseases (NCDs) like hypertension (HTN) and diabetes mellitus (DM) cause 75% of deaths annually, with 82% occurring in low- and middle-income countries (LMICs) [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. In LMICs, up to 70% of individuals with CMHCs receive no care [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e], and treatment for HTN and DM is often inadequate [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. In Nepal, the study setting, HTN and DM are the primary causes of mortality [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e], while CMHCs are the leading contributors to disability [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eCMHCs frequently co-occur with NCDs [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e], with mental health symptoms reported by 30\u0026ndash;32% of individuals with HTN or DM [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Shared behavioral risk factors such as stress, social isolation, tobacco use, low physical activity, poor diet, and medication non-adherence contribute to both conditions leading to morbidity and mortality [\u003cspan additionalcitationids=\"CR13 CR14 CR15 CR16\" citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Moreover, untreated CMHCs can worsen NCD outcomes and vice versa, underscoring the need for integrated approaches to care [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eTo address this gap, the World Health Organization (WHO) has developed clinical guidelines for non-specialist providers, including the mental health Gap Action Program (mhGAP) Intervention Guide [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e], and the Package of Essential Non-communicable Disease Interventions (PEN) [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Both protocols recommend behavioral interventions such as evidence-based stress reduction (EBSR) [\u003cspan additionalcitationids=\"CR24 CR25\" citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e], behavioral activation (BA) [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e], and motivational interviewing (MI) [\u003cspan additionalcitationids=\"CR30\" citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. These low-cost, scalable techniques are suitable for delivery by non-specialists, including primary care providers and community health workers (CHWs) [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]. The unreliable medication supply chain in many LMICs [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e], further underscores the need for behavioral interventions, which are time-limited, cost-effective, and acceptable to patients [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. Few studies have tested integrated behavioral interventions addressing both CMHCs and NCDs concurrently [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eHowever, behavioral care remains underutilized. In Nepal, most patients receive medications alone, with few accessing therapy [\u003cspan additionalcitationids=\"CR41 CR42\" citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e]. Primary Care Providers (PCPs) often lack training in evidence-based techniques, relying instead on educational or judgmental approaches [\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e, \u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e]. Patients, however, frequently prefer counseling to medications [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e, \u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e]. National data also highlight high rates of behavioral risks such as tobacco use, poor diet, and medication non-adherence indicating an urgent need for behavioral interventions [\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e, \u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eClinic-based delivery of such interventions is constrained by short visit times and limited staffing [\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e, \u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e]. CHWs, embedded within communities and already central to health outreach in Nepal and other LMICs [\u003cspan additionalcitationids=\"CR52 CR53 CR54\" citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR55\" class=\"CitationRef\"\u003e55\u003c/span\u003e], offer a more practical solution. Evidence shows CHWs can effectively deliver EBSR [\u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e56\u003c/span\u003e], BA [\u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e57\u003c/span\u003e], MI [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e], and NCD-related counseling [\u003cspan additionalcitationids=\"CR59\" citationid=\"CR58\" class=\"CitationRef\"\u003e58\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR60\" class=\"CitationRef\"\u003e60\u003c/span\u003e]. Our prior work in Nepal [\u003cspan additionalcitationids=\"CR62\" citationid=\"CR61\" class=\"CitationRef\"\u003e61\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR63\" class=\"CitationRef\"\u003e63\u003c/span\u003e], and research by others [\u003cspan citationid=\"CR64\" class=\"CitationRef\"\u003e64\u003c/span\u003e, \u003cspan citationid=\"CR65\" class=\"CitationRef\"\u003e65\u003c/span\u003e], demonstrates that CHWs can effectively deliver culturally adapted behavioral interventions for both CMHCs and NCDs.\u003c/p\u003e\u003cp\u003eYet two gaps persist: First, most CHW interventions target one or two conditions rather than coexisting CMHCs and NCDs [\u003cspan citationid=\"CR66\" class=\"CitationRef\"\u003e66\u003c/span\u003e, \u003cspan citationid=\"CR67\" class=\"CitationRef\"\u003e67\u003c/span\u003e]. For example, combining EBSR with MI could better support tobacco cessation if stress is a barrier [\u003cspan citationid=\"CR68\" class=\"CitationRef\"\u003e68\u003c/span\u003e], and pairing BA with MI could address isolation and inactivity synergistically [\u003cspan citationid=\"CR69\" class=\"CitationRef\"\u003e69\u003c/span\u003e, \u003cspan citationid=\"CR70\" class=\"CitationRef\"\u003e70\u003c/span\u003e]. Second, CHWs face implementation barriers requiring strategies at the CHW level (ongoing skill support) [\u003cspan citationid=\"CR71\" class=\"CitationRef\"\u003e71\u003c/span\u003e, \u003cspan citationid=\"CR72\" class=\"CitationRef\"\u003e72\u003c/span\u003e], interpersonal level (support from patients and PCPs) [\u003cspan citationid=\"CR73\" class=\"CitationRef\"\u003e73\u003c/span\u003e, \u003cspan citationid=\"CR74\" class=\"CitationRef\"\u003e74\u003c/span\u003e], and system level (funding and leadership) [\u003cspan additionalcitationids=\"CR76\" citationid=\"CR75\" class=\"CitationRef\"\u003e75\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR77\" class=\"CitationRef\"\u003e77\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eTo address these gaps, we propose BECOME (Behavioral Community-based COmbined Intervention for MEntal Health and NCDs) an integrated, CHW-delivered home-based intervention combining EBSR, BA, and MI. We have previously piloted its components and tested strategies to support CHW skills, provider and patient engagement, and system-level adoption [\u003cspan citationid=\"CR62\" class=\"CitationRef\"\u003e62\u003c/span\u003e, \u003cspan citationid=\"CR63\" class=\"CitationRef\"\u003e63\u003c/span\u003e]. A robust evaluation is now needed to assess both effectiveness and implementation of BECOME in LMIC settings. This paper presents a novel methodology that employs a community-based, stepped-wedge cluster randomized controlled trial (SWCRT) to conduct this evaluation.\u003c/p\u003e\u003cp\u003eThis study has three objectives: Aim 1 is to assess BECOME effectiveness on depression, anxiety, diabetes, and hypertension using a SWCRT design. Aim 2 is to evaluate implementation outcomes via the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework at patient, provider, and health system levels. Aim 3 is to conduct a comprehensive costing analysis to provide strategic economic insights supporting long-term BECOME scale-up.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eStudy Design\u003c/p\u003e\u003cp\u003eThis is a type-II hybrid implementation-effectiveness study, assessing both effectiveness and implementation where we employ a SWCRT design, with cluster-level randomization stratified by municipality. Each cluster (a ward of ~\u0026thinsp;6,000 people) includes a basic healthcare clinic and is served by one CHW, minimizing contamination risk. The 20 clusters are randomized into five steps using a random number generator, transitioning from control to intervention every three months in groups of four (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Participants in each cluster will be followed up for 12 months after the completion of the intervention. SWCRT is suitable as Government of Nepal (GoN) partners want BECOME deployed across all clusters during the study, and the small number of clusters in GoN\u0026rsquo;s new CHW pilot program aligns well with this design. An open cohort model [\u003cspan additionalcitationids=\"CR79\" citationid=\"CR78\" class=\"CitationRef\"\u003e78\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR80\" class=\"CitationRef\"\u003e80\u003c/span\u003e], is preferred to mimic real-world conditions, support scale-up, maintain target participation during intervention phases, and address attrition or eligibility changes, especially common in CMHCs and NCDs [\u003cspan citationid=\"CR81\" class=\"CitationRef\"\u003e81\u003c/span\u003e, \u003cspan citationid=\"CR82\" class=\"CitationRef\"\u003e82\u003c/span\u003e].\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eFigure \u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Stepped-wedge schedule for 20 clusters with quarterly follow-ups during intervention rollout.\u003c/p\u003e\u003cp\u003eStudy Setting\u003c/p\u003e\u003cp\u003eThe study is being conducted in two municipalities in Nepal, Chandragiri and Bardibas, selected for their socio-economic and geographic diversity, as well as their alignment with GoN\u0026rsquo;s pilot CHW program. Chandragiri, located in the hilly Bagmati Province, has a population of 136,860 with a literacy rate of 87.3% and a provincial Human Development Index (HDI) of 0.652 [\u003cspan citationid=\"CR83\" class=\"CitationRef\"\u003e83\u003c/span\u003e, \u003cspan citationid=\"CR84\" class=\"CitationRef\"\u003e84\u003c/span\u003e]. Bardibas, in the plains of Madhesh Province, has a population of 74,361 and a literacy rate of 72.5% with an HDI of 0.561 [\u003cspan citationid=\"CR83\" class=\"CitationRef\"\u003e83\u003c/span\u003e, \u003cspan citationid=\"CR84\" class=\"CitationRef\"\u003e84\u003c/span\u003e]. These municipalities represent both urbanizing and semi-rural areas, making them ideal for evaluating scalable, community-based health interventions across diverse populations. The CHW program employs salaried, licensed CHWs with three years of clinical training (proficiency certificate in nursing) and mobile tools [\u003cspan citationid=\"CR85\" class=\"CitationRef\"\u003e85\u003c/span\u003e, \u003cspan citationid=\"CR86\" class=\"CitationRef\"\u003e86\u003c/span\u003e]. We focus on CHWs due to GoN\u0026rsquo;s priority and MI\u0026rsquo;s reliance on clinical skills [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. The intervention is supported by Possible, a non-profit organization focused on innovation and research [\u003cspan citationid=\"CR87\" class=\"CitationRef\"\u003e87\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eStudy Population and Eligibility Criteria\u003c/p\u003e\u003cp\u003ePatient Participants must be adult men/women aged\u0026thinsp;\u0026ge;\u0026thinsp;40 years residing in study clusters with no plans to relocate within 2.5 years. Eligible individuals must meet criteria for anxiety and/or depression (Hopkins Symptoms Checklist, HSCL-25, subscale\u0026thinsp;\u0026ge;\u0026thinsp;1.75) and have hypertension (systolic blood pressure-SBP\u0026thinsp;\u0026ge;\u0026thinsp;130 mm Hg or diastolic blood pressure-DBP\u0026thinsp;\u0026ge;\u0026thinsp;80mm Hg) or diabetes (fasting blood glucose-FBG\u0026thinsp;\u0026ge;\u0026thinsp;126 mg/dl or random blood glucose\u0026thinsp;\u0026ge;\u0026thinsp;200 mg/dl). These criteria ensure inclusion of individuals with both CMHCs and NCDs. Individuals with significant cognitive impairment, disabling conditions, or pregnancy/postpartum status (\u0026le;\u0026thinsp;6 weeks) are excluded due to differing care needs. Excluded patients are referred to higher-level care. Those reporting suicidalities are assessed, linked to crisis services, and re-approached for eligibility after stabilization.\u003c/p\u003e\u003cp\u003eCHWs must be actively working in the government pilot community health program (CHP) and trained in the BECOME intervention. No specific exclusion criteria apply to this group.\u003c/p\u003e\u003cp\u003eEligible PCPs must be currently working in health facilities within the catchment areas. They must be willing to participate either in training alone or in both training and the study. We exclude those absent from health facilities within the catchment area during the study period.\u003c/p\u003e\u003cp\u003eHealth System Leaders (HSLs) include supervisors of CHWs, health coordinators from municipal offices within the catchment area, and elected representatives serving their term during the study period who are familiar with CHP. Additionally, other stakeholders who contributed to the design and implementation of CHP are eligible. We exclude those who are absent in the catchment area during the study period.\u003c/p\u003e\u003cp\u003eRandomization and Blinding\u003c/p\u003e\u003cp\u003eThe first step in the cluster randomization process is to identify the 20 clusters to be randomized from among the 14 and 15 clusters in the Bardibas and Chandragiri municipalities, respectively. We randomly select ten clusters from each municipality in the presence of Community Advisory Board (CAB) members to ensure transparency. Next, we randomly select four clusters for implementation of the BECOME intervention every three months. We video-record each randomization step to ensure transparency. We begin the initial household screening in the home located closest to the geographic center of the cluster. We then carry out subsequent screenings in the nearest neighboring household to the one previously screened, continuing this process until we recruit 35 eligible participants.\u003c/p\u003e\u003cp\u003eWe blind the assessment staff (Research Outcome Assessors, ROAs) by restricting their access to intervention materials, using unidentifiable ID numbers, preventing communication between CHWs and ROAs, and scheduling them to work at different times. If any accidental disclosures of cluster allocation occur, we document and address them within the study team and include them in the study analysis. At the end of the study, we plan to conduct qualitative interviews with all ROAs to document any such disclosures.\u003c/p\u003e\u003cp\u003eSample Size and Power Calculations\u003c/p\u003e\u003cp\u003ePower calculations assume 30 patient participants per cluster across 20 clusters over 18 months, with a SWCRT design involving five steps and six periods (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Anticipating some participants will regress to the mean and become ineligible, we will recruit 700 patients. Patients in the last four clusters to transition will be followed until month 30. Using the National Institute of health (NIH) SWCRT sample size calculator [\u003cspan citationid=\"CR88\" class=\"CitationRef\"\u003e88\u003c/span\u003e], we estimated minimum detectable effect sizes with α\u0026thinsp;=\u0026thinsp;0.05, 80% power, and correlations: ICC\u0026thinsp;=\u0026thinsp;0.2 [\u003cspan citationid=\"CR89\" class=\"CitationRef\"\u003e89\u003c/span\u003e], CAC\u0026thinsp;=\u0026thinsp;0.7 [\u003cspan citationid=\"CR90\" class=\"CitationRef\"\u003e90\u003c/span\u003e], and IAC\u0026thinsp;=\u0026thinsp;0.6 [\u003cspan citationid=\"CR81\" class=\"CitationRef\"\u003e81\u003c/span\u003e]. The attrition rate is set at 0.5 due to expected withdrawal, relocation, or ineligibility at treatment start, with up to 30% ineligibility for CMHCs [\u003cspan citationid=\"CR79\" class=\"CitationRef\"\u003e79\u003c/span\u003e, \u003cspan citationid=\"CR81\" class=\"CitationRef\"\u003e81\u003c/span\u003e, \u003cspan citationid=\"CR82\" class=\"CitationRef\"\u003e82\u003c/span\u003e]. These assumptions yield a standardized minimum detectable effect size of 0.34 about 1/3 SD on HSCL-25 indicating a small-to-medium effect [\u003cspan citationid=\"CR91\" class=\"CitationRef\"\u003e91\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eOf 700 patient participants, 30 will complete in-depth interviews (IDIs) at three and 12 months to explore engagement barriers and facilitators. Ten focus group discussions (FGDs) with CHWs will assess intervention delivery, mHealth use, supervision, and support. Five PCPs and six health system leaders will participate in key informant interviews (KIIs) at similar intervals to explore CHW collaboration, perceived feasibility, and system-level support for BECOME scale-up and sustainability.\u003c/p\u003e\u003cp\u003eRecruitment and Data Collection\u003c/p\u003e\u003cp\u003eWe base the sampling frame on the GoN\u0026rsquo;s pilot CHP list and further validate and expand it using data from private health facilities and nonprofits. Among the 40,000 individuals aged\u0026thinsp;\u0026ge;\u0026thinsp;40 years in the 20 clusters, we estimate that 10% have at least one CMHC [\u003cspan citationid=\"CR92\" class=\"CitationRef\"\u003e92\u003c/span\u003e], or target NCD [\u003cspan citationid=\"CR93\" class=\"CitationRef\"\u003e93\u003c/span\u003e], ensuring a sufficient pool to maintain at least 35 participants per cluster per measurement period. Research staff develop the sampling framework in coordination with CHWs and municipal stakeholders. Screening begins at the household nearest to the cluster\u0026rsquo;s geographical center and continues to adjacent homes until we enroll 35 eligible participants per cluster. Eligible participants provide written informed consent and complete baseline assessments via Research Electronic Data Capture (REDCap). ROAs, blinded to allocation, conduct 45 to 60-minute face-to-face interviews in private settings every 3 months for one year following the intervention. We train and supervise ROAs to ensure interview quality, reduce bias, and protect participant confidentiality; and we provide a small financial incentive to participants. The qualitative team will conduct FGDs with CHWs and IDIs and KIIs with patient participants, PCPs, and HSLs.\u003c/p\u003e\u003cp\u003eEnhanced Usual Care\u003c/p\u003e\u003cp\u003eParticipants receive Enhanced Usual Care (EUC) following GoN protocols [\u003cspan citationid=\"CR86\" class=\"CitationRef\"\u003e86\u003c/span\u003e] in all the clusters. CHWs and PCPs receive targeted training on referral criteria and basic CMHC and NCD education. CHWs monitor symptoms and red flags every three months, provide health education, and refer patients as needed. PCPs at health posts conduct screening, monitor patients, provide lifestyle education, and prescribe/refill medications based on WHO\u0026rsquo;s mhGAP [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e], and PEN protocols [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. They also refer patients to higher-level care when necessary.\u003c/p\u003e\u003cp\u003eIntervention Components\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eEBSR\u003c/strong\u003e\u003cp\u003eInvolves diaphragmatic breathing and body scan techniques to manage stress and anxiety, recommended by WHO [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Delivered by trained CHWs over two weeks, each 20 to 30 minute session includes instruction, demonstration, participant practice, feedback, and home practice assignments. Deep breathing is provided to all except those with respiratory issues, who receive body scan exercises. Culturally adapted materials and fidelity checklists exist [\u003cspan citationid=\"CR61\" class=\"CitationRef\"\u003e61\u003c/span\u003e].\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eBA\u003c/strong\u003e\u003cp\u003eEncourages engagement in pleasurable and meaningful activities to reduce depression and increase physical activity. Offered over two weeks in 20 to 30 minute sessions to patients with depression, BA supports mood improvement and active lifestyles. Training materials and fidelity checklists are available [\u003cspan citationid=\"CR61\" class=\"CitationRef\"\u003e61\u003c/span\u003e, \u003cspan citationid=\"CR94\" class=\"CitationRef\"\u003e94\u003c/span\u003e, \u003cspan citationid=\"CR95\" class=\"CitationRef\"\u003e95\u003c/span\u003e].\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMI\u003c/strong\u003e\u003cp\u003eA theory driven counseling method to strengthen motivation for behavior change (e.g., tobacco cessation, nutrition), recommended by WHO PEN protocols [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Delivered in four sessions, MI helps participants explore progress and overcome barriers. Adapted manuals and fidelity checklists are available [\u003cspan citationid=\"CR61\" class=\"CitationRef\"\u003e61\u003c/span\u003e, \u003cspan citationid=\"CR94\" class=\"CitationRef\"\u003e94\u003c/span\u003e].\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eDelivery and Duration\u003c/strong\u003e\u003cp\u003eThe 6\u0026ndash;8 weeks intervention includes weekly 20 to 30 minute CHW home visits. All receive four weeks of MI. Patients with one CMHC (anxiety or depression) receive two weeks of EBSR or BA; those with two CMHCs receive four weeks of both (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Participants who explicitly decline or choose to discontinue the intervention sessions, as well as those who become ineligible to participate in the study due to their health conditions, will be withdrawn from further session delivery after discussion in the study team. CHWs will refer these individuals to appropriate health facilities for further care, and they will continue to receive all other routine health services available within the community.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eTimeline of the BECOME Intervention components.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTimeline​\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eBECOME components​\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eIntervention target​\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eWeeks: 1 and 2\u003c/em\u003e​\u003c/p\u003e\u003cp\u003e(20\u0026ndash;30 minutes each)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eEvidence Based Stress Reduction ​\u003c/p\u003e\u003cp\u003e(Deep breathing or Body Scan) ​\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAnxiety and stress management​\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eWeeks: 3\u0026ndash;4\u003c/em\u003e​\u003c/p\u003e\u003cp\u003e(20\u0026ndash;30 minutes each)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eBehavioral Activation​\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDepression​\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eWeeks: 5\u0026ndash;8\u003c/em\u003e​\u003c/p\u003e\u003cp\u003e(20\u0026ndash;30 minutes each)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMotivational Interviewing​\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003csup\u003ea\u003c/sup\u003eNCD (\u003csup\u003eb\u003c/sup\u003eHTN and/or \u003csup\u003ec\u003c/sup\u003eDM) targeting behavior change or maintenance ​\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"3\"\u003e\u003csup\u003ea\u003c/sup\u003eNCD: Non-communicable disease; \u003csup\u003eb\u003c/sup\u003eHTN: Hypertension; \u003csup\u003ec\u003c/sup\u003eDM: Diabetes Mellitus\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"3\"\u003eRetention\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eTo improve retention, we leverage CHWs who have strong local networks and familiarity with households. ROAs verify and update participant contact information at each assessment. If participants are unreachable, ROAs follow a 14-day structured outreach protocol, including calls and home visits. The study team reaches out to CHWs for support if needed. Regular CHW visits for health surveillance are routine and unlikely to cause stigma. Quarterly CAB meetings serve as a source of guidance and provide independent feedback and critique to strengthen the research process that is respectful of, acceptable to, and responsive to the community.\u003c/p\u003e\u003cp\u003eOutcomes for Aim 1\u003c/p\u003e\u003cp\u003eThe primary outcome measure is CMHC severity, measured by mean HSCL-25 score collected at 3-month intervals, alongside all other measures. Secondary measures include mean SBP and DBP for HTN, and mean FBG for DM. Behavioral measures include tobacco use, physical activity, diet quality, medication adherence, and adherence to follow-up (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eKey model variables and associated components (collected quarterly except demographics).\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eKey model variables\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eDescription of scales\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eIntervention components\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eDemographics\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAge, education, languages spoken, religion, income, and caste\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eDepression, Anxiety\u003c/b\u003e\u003c/p\u003e\u003cp\u003ePrimary outcome\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eHopkins Symptom Checklist (HSCL-25) includes depression and anxiety subscales on a 4-point like scale validated and used locally in Nepal.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003csup\u003ea\u003c/sup\u003eEBSR for anxiety\u003c/p\u003e\u003cp\u003e\u003csup\u003eb\u003c/sup\u003eBA for depression\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003csup\u003e\u003cb\u003ed\u003c/b\u003e\u003c/sup\u003e\u003cb\u003eNCD outcomes\u003c/b\u003e\u003c/p\u003e\u003cp\u003eSecondary outcomes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMean systolic blood pressure (SBP), diastolic blood pressure (DBP), and fasting plasma glucose, measured by research staff with manual cuff and point of care test.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003csup\u003ec\u003c/sup\u003eMI for all behavioral targets\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eIsolation and withdrawal\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eBehavioral Activation for Depression Scale (BADS-SF) 9-items to assess withdrawal from or engagement in rewarding activities, adapted by our team.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eBA for isolation and depression\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eQuality of life\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eWHO Quality of\u003c/p\u003e\u003cp\u003eLife (WHOQOL) 26 items on physical health, psychological well-being and social functioning; validated in Nepal.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAll intervention components\u003c/p\u003e\u003cp\u003eEBSR, BA, MI\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eTobacco use\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 questions from Global Adult Tobacco Survey (GATS) to assess current and past smoked or smokeless tobacco use, quit attempts and intention to quit; used in Nepal.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMI for tobacco avoidance\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eDiet quality\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eDiet Quality Questionnaire (DQQ) Binary questions about food groups (29 items) consumed in the previous day; adapted in many countries, including Nepal.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMI for improving and maintaining diet quality\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePhysical activity\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eGlobal Physical Activity Questionnaire (GPAQ) 16 items to assess physical activity in work, travel and leisure; used in Nepal\u0026rsquo;s national survey.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMI for improving and maintaining physical activity\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eMedication adherence\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 day recall for medication adherence, adapted by our team in MI studies in Nepal, \u0026lt;\u0026thinsp;90% considered low adherence, based on current literature.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMI for medication adherence\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eRegular clinic follow-up\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMissed a scheduled follow-up clinic visit in 2 weeks or more used by our team in current MI studies in Nepal.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMI for regular clinic follow up\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"3\"\u003e\u003csup\u003ea\u003c/sup\u003eEBSR: Evidenced Based Stress Reduction; \u003csup\u003eb\u003c/sup\u003eBA: Behavioral Activation; \u003csup\u003ec\u003c/sup\u003eMI: Motivational Interviewing; \u003csup\u003ed\u003c/sup\u003eNCD: Non-communicable disease\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"3\"\u003eOutcomes and Implementation Strategies for Aim 2\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eTo ensure sustainable implementation in real-world settings, we use three implementation strategies developed using the COM-B framework, which addresses Capability (the individual\u0026rsquo;s psychological and physical capacity to engage in the behavior), Opportunity (external factors that make the behavior possible or prompt it), and Motivation (internal processes influencing behavior) to achieve CHWs delivering BECOME effectively [\u003cspan citationid=\"CR96\" class=\"CitationRef\"\u003e96\u003c/span\u003e]. These strategies operate at intrapersonal, interpersonal, and health system levels. Implementation outcomes are assessed via the RE-AIM framework [\u003cspan citationid=\"CR97\" class=\"CitationRef\"\u003e97\u003c/span\u003e].\u003c/p\u003e\u003cp\u003e\u003cb\u003eStrategy 1: mHealth App to enhance fidelity (Intrapersonal Level)\u003c/b\u003e\u003c/p\u003e\u003cp\u003eMaintaining fidelity is critical, as CHWs often revert to advice-giving instead of evidence-based techniques [\u003cspan citationid=\"CR71\" class=\"CitationRef\"\u003e71\u003c/span\u003e]. A decision support app tested with 30 CHWs in a pilot study [\u003cspan citationid=\"CR94\" class=\"CitationRef\"\u003e94\u003c/span\u003e], provides real-time guidance and audio recordings for supervisor feedback. Acceptability was high: 94% found it helpful, and 100% adopted it. Impact is measured via app usage, CHW FGDs, and fidelity scores (\u0026ge;\u0026thinsp;80% on BECOME checklist).\u003c/p\u003e\u003cp\u003e\u003cb\u003eStrategy 2: CHWs training PCPs to improve attitudes (Interpersonal Level)\u003c/b\u003e\u003c/p\u003e\u003cp\u003eNegative attitudes toward behavioral interventions among PCPs and patients can hinder adoption [\u003cspan citationid=\"CR73\" class=\"CitationRef\"\u003e73\u003c/span\u003e, \u003cspan citationid=\"CR74\" class=\"CitationRef\"\u003e74\u003c/span\u003e]. Training PCPs in stress-relief techniques like EBSR and BA improves their attitudes and willingness to recommend these interventions [\u003cspan citationid=\"CR98\" class=\"CitationRef\"\u003e98\u003c/span\u003e]. Co-delivery of training by CHWs and mental health specialists enhances CHWs\u0026rsquo; credibility and PCP engagement, aligning with the COM-B framework [\u003cspan citationid=\"CR96\" class=\"CitationRef\"\u003e96\u003c/span\u003e, \u003cspan citationid=\"CR99\" class=\"CitationRef\"\u003e99\u003c/span\u003e]. Measurements include pre/post attitude surveys, patient interviews, intervention reach, and quarterly perception surveys.\u003c/p\u003e\u003cp\u003e\u003cb\u003eStrategy 3: Interdisciplinary case conferences (ICCs) to highlight CHWs\u0026rsquo; impact (Health System Level)\u003c/b\u003e\u003c/p\u003e\u003cp\u003eLimited recognition of CHWs is a barrier to sustainability [\u003cspan citationid=\"CR67\" class=\"CitationRef\"\u003e67\u003c/span\u003e]. ICCs, where CHWs and PCPs present cases together, improve health leaders\u0026rsquo; perceptions [\u003cspan citationid=\"CR96\" class=\"CitationRef\"\u003e96\u003c/span\u003e]. ICCs are integrated into biannual health leader meetings, with pre/post surveys and CHW support and maintenance tracked at 12 months.\u003c/p\u003e\u003cp\u003eOutcomes for Aim 3\u003c/p\u003e\u003cp\u003eAim 3 supports policymakers in evaluating BECOME for scale-up by estimating average costs per beneficiary per CHW, analyzing cost variation across clusters and patient profiles, and assessing resource needs for scaling the implementation strategies.\u003c/p\u003e\u003cp\u003eData Management and Analysis Plan\u003c/p\u003e\u003cp\u003eROAs collect data from the assessment tools (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) using encrypted, password-protected tablets with the REDCap mobile app. Staff store data securely on devices until they upload it to a secure server. They store all identifying information such as consent forms and contact logs separately under lock and key. Staff do not store identifying information on the same devices or in the same locations as study data. CHWs record intervention sessions on encrypted, password-protected phones already used for patient data collection. They review audio recordings privately with research counselors for supervision and feedback. The research team randomly selects at least one recording per CHW for fidelity review using BECOME fidelity rating scale adapted from WHO\u0026rsquo;s Ensuring Quality in Psychological Support (EQUIP) platform. Only two authorized team members access these recordings, which they store temporarily on an encrypted, password-protected laptop and delete after review. A data manager, supervised by the senior statistician review study data monthly to monitor completeness, accuracy, protocol adherence, and participant safety.\u003c/p\u003e\u003cp\u003eFor Aim 1, we will use generalized linear mixed models to evaluate the BECOME intervention\u0026rsquo;s impact on HSCL-25 scores, applying an intention-to-treat approach. Continuous outcomes will use a normal distribution with an identity link, with fixed effects for secular and intervention trends and random effects for individual, cluster, and time-level variability. The intervention effect will include a constant term and a treatment-by-time interaction, with random intercepts for participants and clusters. This method will also assess secondary outcomes (e.g., FBG, SBP, DBP). Binary outcomes (e.g., optimal adherence) will apply the same model structure with a Bernoulli distribution and logit link. Structural Equation Modeling will further explore direct, indirect, and synergistic effects of intervention components via mediators (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eFigure \u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. Conceptual model to improve CMHCs and NCDs using EBSR, BA, MI, and implementation strategies.\u003c/p\u003e\u003cp\u003eCMHCs: Common Mental Health Conditions; NCDs: Non-communicable Diseases; CHW: Community Health Worker; HSCL-Hopkins Symptom Checklist\u003c/p\u003e\u003cp\u003eAim 2 involves a mixed-methods evaluation of implementation mechanisms using surveys and 71 in-depth interviews (30 patients-2 times, six leaders, five PCPs) and 10 FGDs, coded thematically in Dedoose. A preliminary codebook will be refined collaboratively, ensuring\u0026thinsp;\u0026ge;\u0026thinsp;80% intercoder reliability. Memos will explore links among strategies, mechanisms, and outcomes.\u003c/p\u003e\u003cp\u003eAdditionally, CHW app usage data will be passively collected via the Community Health Toolkit, integrated into daily workflows without adding burden to CHWs.\u003c/p\u003e\u003cp\u003eCosting Analysis Plan for Aim 3\u003c/p\u003e\u003cp\u003eAim 3 uses programmatic and financial data to conduct a comprehensive cost analysis of delivering BECOME. Costing will use a bottom-up (micro-costing) approach at the beneficiary level, calculating total cost per CHW visit and deriving average intervention costs, including its components [\u003cspan citationid=\"CR100\" class=\"CitationRef\"\u003e100\u003c/span\u003e]. Both recurrent costs and capital cost depreciation will be measured using Time-Defined Activity-Based Costing (TDABC), which details resource use across care delivery [\u003cspan additionalcitationids=\"CR102 CR103\" citationid=\"CR101\" class=\"CitationRef\"\u003e101\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR104\" class=\"CitationRef\"\u003e104\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eData sources include CHW time logs, CHW surveys on indirect resource use, researcher records of CHW, PCP training and ICC, along with financial records from municipalities and the BECOME team. CHW services are funded through municipal budgets under the Government of Nepal\u0026rsquo;s CHW program. Prior costing from a similar rural CHW program in Nepal [\u003cspan citationid=\"CR105\" class=\"CitationRef\"\u003e105\u003c/span\u003e], informs our methods. The analysis will disaggregate costs by intervention component (EBSR, BA, MI) and function (patient care, supervision, data monitoring, administration), and detail start-up costs and cost heterogeneity by cluster and patient characteristics such as comorbidities and behavioral goals.\u003c/p\u003e\u003cp\u003eParticipant Safety, Adverse Event Management and Data Monitoring\u003c/p\u003e\u003cp\u003eThe Co-Principal Investigators (Co-PIs) supervise the study directly, with the site Principal Investigator (PI) and the research project manager overseeing daily operations. Co-Investigators and domain-specific experts provide additional guidance and monitoring. All team members complete training in research ethics and human subject\u0026rsquo;s protection and sign a confidentiality agreement before initiating any participant interaction. The study team actively safeguards the safety and confidentiality of all participants during assessments and intervention.\u003c/p\u003e\u003cp\u003eIf a participant shows signs of ongoing distress despite CHW-delivered support, displays red flags per mhGAP or PEN protocols, or requests higher-intensity care for CMHCs or NCDs, the team refers them according to the referral pathway to the nearby hospitals. When ROAs identify any participant at high or acute risk of suicide, they follow the crisis management pathway and immediately connect them with a contracted crisis counselor for evaluation and support. If they require urgent intervention, the team coordinates with their emergency contact and refers them to a nearby tertiary care facility. If no immediate referral is needed, ROAs provide the participant with a resource card listing relevant support services. In both cases, a study team member and the crisis counselor follow up within 48 hours to ensure the participant\u0026rsquo;s safety and well-being.\u003c/p\u003e\u003cp\u003eAll study staff report adverse events including breaches of confidentiality to the research project manager, who escalates them to the site PI. The team documents all adverse events in an Adverse Event Summary Log and attaches them to the Continuing Review or Study Closeout Forms, following each Institutional Review Board (IRB)\u0026rsquo;s reporting guidelines. For serious adverse events, the research coordinator immediately notifies the site PI, who then informs the IRB of the Nepal Health Research Council (NHRC) within 48 hours and submit a detailed report within two weeks. We also conduct interim analyses between follow-up assessments to monitor changes in CMHCs and NCD severity, ensuring no unintended increases occur. We also document all adverse and serious adverse events to protect participant safety and evaluate any potential risks associated with the BECOME intervention.\u003c/p\u003e\u003cp\u003eAn independent Data Safety and Monitoring Board (DSMB) oversees participant protection throughout the study. The board includes five experts in CMHCs, NCDs, biostatistics, and community-based research, and meets semi-annually (virtually or in person). The Co-PIs prepare and submit detailed reports for each meeting. The DSMB reviews participant safety protocols, confidentiality protections, and all adverse event reports. In the case of a serious adverse event, the DSMB chair may call an ad hoc meeting. The board may request additional information as needed. DSMB reports are shared with the Co-PIs and all participating IRBs to ensure transparency and accountability.\u003c/p\u003e\u003cp\u003eTrial Quality Control and Auditing\u003c/p\u003e\u003cp\u003eThe site Principal Investigator and Research Project Manager conduct weekly reviews to monitor study implementation and monthly reviews to assess recruitment, retention, participant safety, and any methodological issues. We submit biannual recruitment and performance progress reports to the National Institute of Mental Health (NIMH) and undergo annual continuing ethical review by both the NHRC and the University of California, San Francisco.\u003c/p\u003e\u003cp\u003eOur Nepal\u0026ndash;US research team ensures structured implementation through pilot-tested manuals that standardize data collection and intervention delivery. CHWs complete competency-based certification using the BECOME fidelity checklist, and research staff receive training to meet performance standards. We re-train any staff who do not meet benchmarks before certification to maintain intervention quality. Monthly investigator calls, quarterly steering committee and implementation research committee meetings facilitate communication, coordination, and oversight, supporting consistent progress and collaborative management of the trial.\u003c/p\u003e\u003cp\u003eWe used SPIRIT reporting guidelines to report this protocol [\u003cspan citationid=\"CR106\" class=\"CitationRef\"\u003e106\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eDissemination Plan\u003c/p\u003e\u003cp\u003eWe plan to actively disseminate study findings to inform public health policy, community programs, and future research. The results contribute to the development of integrated behavioral interventions for CMHCs and NCDs and offer a model for implementation in Nepal and similar low-resource settings. We plan to share findings with public health officials, regional and national policymakers, hospital administrators, non-governmental organizations, community members, and the international academic community. Dissemination efforts include submitting manuscripts to peer-reviewed journals, presenting at conferences, and organizing a dissemination meeting in Kathmandu in Year five to directly engage stakeholders. We also plan to develop policy briefs and fact sheets to summarize key findings and recommendations, ensuring broad access and practical use of the study outcomes.\u003c/p\u003e\u003cp\u003eFollowing the current NIH- Data Management and Sharing Policy, we will submit de-identified quantitative participant-level data to the NIMH Data Archive within one year of study completion. At the time of publication, we will also share the corresponding statistical analysis code and codebooks for any qualitative data included in published findings.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study addresses a critical gap in the integrated management of co-occurring CMHCs and NCDs in low- and middle-income countries LMICs, where fragmented care, stigma, and limited resources hinder effective service delivery. By training and mobilizing CHWs to deliver evidence-based behavioral interventions-EBSR, BA, and MI, the study leverages a scalable, task-shifted approach to bridge mental and physical health care in community settings. Delivering these interventions directly to patients\u0026rsquo; homes addresses structural barriers such as transportation costs, stigma associated with facility-based mental health care, and limited clinic capacity. This decentralized, community-based model enhances accessibility and feasibility, particularly in rural and under-resourced areas like Nepal. The SWCRT design offers a rigorous framework for evaluating both effectiveness and implementation while ensuring that all clusters eventually receive the intervention, addressing ethical concerns related to withholding care.\u003c/p\u003e\u003cp\u003eThe study employs implementation strategies grounded in the COM-B model, which allows for systematic identification and mitigation of barriers to delivery. It also integrates the RE-AIM framework to assess multilevel implementation outcomes at the individual, provider, and system levels, enhancing the potential for generalizability and real-world translation. In addition to evaluating clinical and behavioral outcomes including depression and anxiety symptom reduction, improved medication adherence, tobacco cessation, and physical activity the study includes a detailed costing analysis using the TDABC approach. This will enable policymakers to understand the financial implications of scaling up the intervention within the public health system and inform decisions on sustainability, resource allocation, and integration into existing service delivery platforms.\u003c/p\u003e\u003cp\u003eDespite inherent challenges, including the need to maintain intervention fidelity and mitigate participant attrition, the study incorporates multiple quality assurance mechanisms. These include standardized training and certification of CHWs using the BECOME fidelity checklist, ongoing supervision, and performance monitoring. The trial\u0026rsquo;s embedding within government-run pilot community health program and its alignment with existing Ministry of Health and Population structures enhance feasibility, acceptability, and the likelihood of long-term adoption.\u003c/p\u003e\u003cp\u003eAlthough the intervention\u0026rsquo;s short duration may limit measurable impact on long-term NCD outcomes such as blood pressure or glycemic control, the study prioritizes early behavioral indicators and intermediate outcomes. These outcomes are predictive of improved clinical trajectories and align with WHO PEN and mhGAP guidelines. In addition, the study incorporates contingency planning for potential challenges, including alternative recruitment strategies and the replacement of inactive clusters.\u003c/p\u003e\u003cp\u003eWith adequate statistical power to detect medium effect sizes even with a limited number of clusters, the study maintains scientific rigor while ensuring practical feasibility. Successful implementation within GoN health clusters will not only facilitate potential national scale-up but also generate critical implementation insights relevant to similar LMIC contexts seeking to integrate mental and physical health care through community-based platforms.\u003c/p\u003e\u003cp\u003e\u003cb\u003eTrial Status\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis protocol version is 1.0 dated 14 June, 2024. 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. The detailed schedule of enrollment, intervention and assessments is presented in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eSchedule of enrollment, interventions, and assessments.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"13\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c12\" colnum=\"12\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c13\" colnum=\"13\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colspan=\"10\" nameend=\"c12\" namest=\"c3\"\u003e\u003cp\u003eStudy Period\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTIMEPOINT\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cb\u003eYear 1\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c6\" namest=\"c3\"\u003e\u003cp\u003e\u003cb\u003eYear 2\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c10\" namest=\"c7\"\u003e\u003cp\u003e\u003cb\u003eYear 3\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c13\" namest=\"c11\"\u003e\u003cp\u003e\u003cb\u003eYear 4 and 5\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e10\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eMonths\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1\u0026ndash;3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e4\u0026ndash;6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e7\u0026ndash;9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e10\u0026ndash;12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e13\u0026ndash;15\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e16\u0026ndash;18\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e19\u0026ndash;21\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e22\u0026ndash;24\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e25\u0026ndash;27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e28\u0026ndash;30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePreparation phase\u003c/b\u003e (develop protocol, hire/train staffs, etc.)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eAllocation\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"11\" nameend=\"c13\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRandom allocation of 20 clusters (10 clusters from each site)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRandom allocation of 4 clusters per each intervention phase\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eEnrollment\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"11\" nameend=\"c13\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEligibility Screening\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eInformed consent\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eIntervention\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"11\" nameend=\"c13\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTraining of interventionists and intervention delivery (4 clusters receive intervention at each intervention phase)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eX (cluster 1\u0026ndash;4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eX (cluster 5\u0026ndash;8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eX (cluster 9\u0026ndash;12)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX (cluster 13\u0026ndash;16)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003eX (cluster 17\u0026ndash;20)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEnhanced usual care (in remaining unselected clusters)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eAssessments\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"11\" nameend=\"c13\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBaseline\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFollow up\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eAnalysis of\u003c/b\u003e:\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"11\" nameend=\"c13\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrimary and secondary outcomes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eImplementation outcomes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCost-effectiveness\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003eX\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eBA\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eBehavioral Activation\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eBADS\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eBehavioral Activation for Depression Scale\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eBECOME\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eBehavioral Community-based Combined Intervention for Mental Health and Non-communicable Disease\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eCAB\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eCommunity Advisory Board\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eCHP\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eCommunity Health Program\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eCHW\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eCommunity Health Worker\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eCMHCs\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eCommon Mental Health Conditions\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eCOM-B\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003ecapability (C), opportunity (O) and motivation (M) are essential for any behavior (B) to change\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eCo-PI\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eCo-Principal Investigator\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eDBP\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eDiastolic Blood Pressure\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eDM\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eDiabetes Mellitus\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eDQQ\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eDiet Quality Questionnaire\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eDSMB\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eData Safety and Monitoring Board\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eEBSR\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eEvidence Based Stress Reduction\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eEUC\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eEnhanced Usual Care\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eFBG\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eFasting Blood Glucose\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eFGDs\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eFocus group discussions\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eGATS\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eGlobal Adult Tobacco Survey\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eGoN\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eGovernment of Nepal\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eGPAQ\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eGlobal Physical Activity Questionnaire\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eHDI\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eHuman Development Index\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eHSCL\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eHopkins Symptom Checklist\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eHSL\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eHealth System Leaders\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eHTN\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eHypertension\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eICC\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eInterdisciplinary Case Conference\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eIDIs\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eIn-depth Interviews\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eIRB\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eInstitutional Review Board\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eKIIs\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eKey Informant Interviews\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eLMICs\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eLower Middle-Income Countries\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003emhGAP\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003emental health Gap Action Program\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eMI\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eMotivational Interviewing\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eNCDs\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eNon-communicable diseases\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eNHRC\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eNepal Health Research Council\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eNIH\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eNational Institute of Health\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eNIMH\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eNational Institute of Mental Health\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003ePCPs\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003ePrimary Care Providers\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003ePEN\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003ePackage of Essential Non-communicable Disease Interventions\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003ePI\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003ePrincipal Investigator\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eRE-AIM\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eReach, Effectiveness, Adoption, Implementation, and Maintenance\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eREDCap\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eResearch Electronic Data Capture\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eROAs\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eResearch Outcome Assessors\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eSBP\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eSystolic Blood Pressure\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eSWCRT\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eStepped-wedge cluster randomized controlled trial\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eTDABC\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eTime-Defined Activity-Based Costing\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eWHO\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eWorld Health Organization\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eWHO EQUIP\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eWHO Ensuring Quality in Psychological Support\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003e\u003cb\u003eWHO QOL\u003c/b\u003e\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eWHO Quality of life\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthical approval and consent to participate\u003c/strong\u003e\u003cp\u003eThe ethical approval for the study is obtained from institutional review boards of both University of California, San Francisco (IRB #22-38288) on 04/06/2023 and Nepal Health Research Council (registration #256/2023) on 07/13/2023. The trained ROAs obtain written informed consent from all participants prior to enrollment, and verbal consent before follow up assessments, including IDIs. Any amendments to the trial protocol are communicated to the relevant ethical/institutional review boards, participants and members of the data safety and monitoring board.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003cp\u003eNot Applicable. We will provide the model consent form upon request.\u003c/p\u003e\u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e\u003cp\u003eThis research is supported by the National Institute of Mental Health of the National Institutes of Health under Award Number R01MH133231. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The study funder or sponsor doesn\u0026rsquo;t have any direct role in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.\u003c/p\u003e\u003ch2\u003eAuthors\u0026rsquo; contributions\u003c/h2\u003e\u003cp\u003eBA and Sabitri S are the senior authors who conceived the research idea. BA, Sabitri S, Srijana S, KS (first author), AS, BR, HKN, Dean S, EH, MD, PPB and DP contributed to the design of the study. PN contributed to the costing analysis plan. KS, Srijana S, BA, and PL developed the BECOME training manual. Dikshya S, SN, SJ, ST, PP, NKS, JS and JN developed the questionnaires and interview guides. SP, BY, JN, KS, PL and Dikshya S contributed to the mHealth tool development. KS and JN drafted the manuscript. All authors read and approved the final manuscript. All authors declare that they have no competing financial interests.\u003c/p\u003e\u003ch2\u003eAcknowledgements\u003c/h2\u003e\u003cp\u003eWe extend our sincere gratitude to the study participants and their families. We also acknowledge the support of local stakeholders in Bardibas and Chandragiri municipalities for facilitating the implementation of this research. Our appreciation extends to the Ministry of Health and Population, the Nursing and Social Security Division, Epidemiology and Disease Control Division, and the members of the Implementation Research Committee and Community Advisory Board for their guidance, support, and constructive feedback throughout the study.\u003c/p\u003e\u003ch2\u003eAvailability of data and materials\u003c/h2\u003e\u003cp\u003eWe will submit de-identified participant-level data to the NIMH Data Archive. Alongside the dissemination of study findings, we will make all associated statistical code publicly available to ensure transparency and reproducibility.\u003c/p\u003e\u003cp\u003eCompeting interests\u003c/p\u003e\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eGBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990\u0026ndash;2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022;9(2):137\u0026ndash;50.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eIHME. Global Burden of Disease Collaborative Network. Global Burden of Disease Study 2019 (GBD 2019) Results. 2020.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAlonso J, Liu Z, Evans-Lacko S, Sadikova E, Sampson N, Chatterji S, et al. 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Package of Essential Noncommunicable (PEN) Disease Interventions for Primary Health Care in Low-Resource Settings. Geneva, Switzerland: World Health Organization; 2010.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWHO. Package of Essential Noncommunicable (PEN) disease and healthy lifestyle interventions: Training modules for primary health care workers. New Delhi: World Health Organization, Regional Office for South-East Asia; 2018.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBlanck P, Perleth S, Heidenreich T, Kr\u0026ouml;ger P, Ditzen B, Bents H, et al. Effects of mindfulness exercises as stand-alone intervention on symptoms of anxiety and depression: Systematic review and meta-analysis. Behav Res Ther. 2018;102:25\u0026ndash;35.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNg DL, Chai CS, Tan KL, Chee KH, Tung YZ, Wai SY, et al. 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BMJ. 2013;346:e7586.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":true,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Implementation research, behavioral intervention, mental health, Non-communicable diseases, community health workers, Nepal","lastPublishedDoi":"10.21203/rs.3.rs-7065341/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7065341/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eCommon 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.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eThis 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.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e\u003cp\u003eParticipant 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.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e\u003cp\u003eClinicalTrials.gov, NCT06449521, Registered on 25 April, 2024, \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://register.clinicaltrials.gov/prs/beta/studies/S000DZJN00000112/recordSummary\u003c/span\u003e\u003cspan address=\"https://register.clinicaltrials.gov/prs/beta/studies/S000DZJN00000112/recordSummary\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e","manuscriptTitle":"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","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-18 06:34:04","doi":"10.21203/rs.3.rs-7065341/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Accept","date":"2026-01-12T15:02:35+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2025-10-06T21:38:31+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-06T21:05:14+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-07-12T16:26:33+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-07-07T08:19:51+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"1a1650f6-6fb9-45d4-a493-8d6213e83afd","owner":[],"postedDate":"October 18th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-01-26T16:03:58+00:00","versionOfRecord":{"articleIdentity":"rs-7065341","link":"https://doi.org/10.1186/s13063-026-09457-1","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2026-01-24 15:58:54","publishedOnDateReadable":"January 24th, 2026"},"versionCreatedAt":"2025-10-18 06:34:04","video":"","vorDoi":"10.1186/s13063-026-09457-1","vorDoiUrl":"https://doi.org/10.1186/s13063-026-09457-1","workflowStages":[]},"version":"v1","identity":"rs-7065341","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7065341","identity":"rs-7065341","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}