BECOME COmbined Intervention for MH & NCD Delivered by Community Health Workers in Nepal
A Type II Hybrid Implementation-effectiveness Study of BECOME (BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases) Delivered by Community Health Workers in Nepal
Possible
700 participants
Jul 16, 2024
INTERVENTIONAL
Conditions
Summary
Common mental health disorders (CMDs) and noncommunicable diseases (NCDs) pose significant public health challenges, especially in resource-limited settings like Nepal. The coexistence of CMDs and NCDs is prevalent, tied together by shared behavioral risk factors including stress, isolation, tobacco use, low physical activity, poor diet, and treatment non-adherence. Addressing these risk factors through behavioral interventions has the potential to positively impact both CMDs and NCDs. While the World Health Organization (WHO) recommends three behavioral interventions-evidence-based stress reduction (EBSR) for stress and anxiety, behavioral activation (BA) for depression, and motivational interviewing (MI) for healthy behaviors-availability remains scarce in low-resource settings. This research proposes a hybrid implementation-effectiveness study of the BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases (BECOME) in Nepal. BECOME, delivered by community health workers (CHWs), integrates EBSR, BA, and MI to improve mental health and address NCDs. The study employs a stepped-wedge cluster randomized trial, with 20 clusters randomly assigned to five steps, starting in the control condition. Transitioning every three months, clusters gradually adopt the intervention, minimizing logistical challenges during implementation. The study targets 600 patient participants (age 40 years and above with at least one CMD and NCD) from Bardibas and Chandragiri municipalities, involving 20 CHWs, five primary care providers (PCPs), and six health system leaders. CHWs identify potential participants, with research staff assessing eligibility, obtaining informed consent, and conducting baseline assessments using a digital REDCap tool. CHWs undergo BECOME intervention training, delivering it to consenting patient participants (30 per CHW). Quantitative data collected quarterly over 12 months will measure primary outcomes for CMDs and NCDs. Additionally, qualitative components, following the Reach Effectiveness-Adoption Implementation and Maintenance (RE-AIM) framework, include focus group discussions (FGDs) with CHWs and Key Informant Interviews (KIIs) with patient participants, PCPs, and health system leaders to assess implementation mechanisms, outcomes, and clinical impact. The study, if successful, aims to furnish evidence and a model for implementing behavioral interventions addressing CMDs and NCDs.
Eligibility
Inclusion Criteria4
- Adult men and women age ≥ 40 years
- Living in the target wards with no intention of leaving in the next 2.5 yrs
- Anxiety (HSCL-25 anxiety subscale score ≥1.75) and/or Depression (HSCL-25 depression subscale score ≥1.75)
- At least one Non-communicable disease (NCD) based on WHO PEN criteria; either Hypertension (HTN) (SBP ≥130mmHg and/or DBP ≥80mmHg) and/or Diabetes Mellitus (DM) (fasting plasma glucose (FPG) ≥126mg/dl or random plasma glucose ≥200mg/dl)
Exclusion Criteria3
- Significant cognitive problems/disability
- Pregnant women
- Postpartum (≤6 weeks) women
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Interventions
The intervention, BECOME, includes: a) Evidence-based stress reduction (EBSR): as recommended in the WHO mhGAP guidelines, diaphragmatic breathing and body scan will be used to manage stress and anxiety. b) Behavioral activation (BA): as recommended in the mhGAP guidelines, this evidence-based strategy will increase the time that patients spend engaging in pleasurable activities to both treat depression and increase physical activity, depending on their cognitive and physical capabilities (e.g., going to a neighbor's house for tea or walking to the local market). c) Motivational interviewing (MI): an evidence-based patient-interaction strategy that increases the patient's internal motivation to engage in healthy behaviors (e.g., quit tobacco) both to prompt change (if they are not engaging in healthy behaviors) and maintain them (if they are already engaged in healthy behaviors), as recommended by Package of Essential Noncommunicable disease interventions) PEN protocols.
Locations(1)
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NCT06449521