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

项目摘要 常见的精神健康障碍(CMD)，如抑郁和焦虑，以及非传染性 糖尿病和高血压等疾病(NCDs)非常普遍，是导致死亡和 世界各地的残疾人，特别是在资源匮乏的环境中，如我们在尼泊尔的研究站点。三人共病 CMDS和NCDS较高，这些情况之间的关系是复杂的和多方向的。 几个常见的行为风险因素会使这两种情况恶化：压力、孤立、吸烟、低体力 运动量大，饮食质量低，治疗依从性差。行为干预可以解决这些常见的问题 风险因素，并改善慢性精神疾病和非传染性疾病。世界卫生组织(WHO)的两项临床方案 CMDS和NCDS建议进行三种行为干预：a)循证减压(EBSR) 压力/焦虑；b)抑郁的行为激活(BA)；以及c)健康的动机访谈(MI 行为。尽管有这种潜力，但这些干预措施很少在资源匮乏的环境中使用，因为 两个重要的差距：1)行为干预通常针对一到两个慢性精神疾病和非传染性疾病进行研究， 而不是为了满足集成干预的实际需要，以同时解决多个CMD和 非传染性疾病；和2)这些干预措施尚未使用能够支持Easy的执行战略进行研究 在现实世界中获得(即在患者家中或附近提供护理)和持续实施 设置。基于我们广泛的历史和在尼泊尔工作的长期承诺，我们现在提出一个 基于行为社区的组合干预的混合实施效果研究 精神健康和非传染性疾病)由尼泊尔社区卫生工作者(CHW)提供。 我们的团队在进行实施研究、整合证据方面有着悠久的历史- 在尼泊尔现有的卫生保健系统中纳入对慢性精神疾病和非传染性疾病的基础护理，培训社区卫生工作者提供 在患者家中或附近进行行为干预，并进行成本分析。我们有一个广泛的 与尼泊尔政府合作的历史，对社会规范和 推动可持续医疗服务提供的文化因素。拟议的研究有三个目标，以解决 以上发现的差距：目的1)评估成为治疗抑郁症、焦虑症和两种非传染性疾病的有效性 一项阶梯式楔形群随机试验(20个地理群)和参与者(n=600)，至少有一个 CMD和一项非传染性疾病；目的2)评估使用REACH的实施结果、有效性、 患者、提供者和医疗系统的采用、实施和维护(RE-AIM)框架 目标3)进行全面的成本分析，以提供战略投入，支持长期 放大成为。如果成功，这项研究将为中国政府提供证据和蓝图 尼泊尔和其他低资源环境，采取综合干预措施和一套执行战略，以 提供针对慢性精神疾病和非传染性疾病的行为干预。

Project Abstract Common mental health disorders (CMDs), like depression and anxiety, and non-communicable diseases (NCDs), like diabetes and hypertension, are highly prevalent and are the leading causes of death and disability worldwide, especially in low-resource settings like our research site in Nepal. Comorbidity among CMDs and NCDs is high and the relationship between these conditions is complex and multidirectional. Several common behavioral risk factors worsen both conditions: stress, isolation, tobacco use, low physical activity, low quality diet, and poor treatment adherence. Behavioral interventions can address these common risk factors, and improve CMDs and NCDs. The World Health Organization's (WHO) two clinical protocols for CMDs and NCDs recommend three behavioral interventions: a) evidence-based stress reduction (EBSR) for stress/anxiety; b) behavioral activation (BA) for depression; and c) motivational interviewing (MI) for healthy behaviors. Despite this potential, these interventions are rarely available in low-resource settings because of two important gaps: 1) behavioral interventions have often been studied for one or two CMDs and NCDs, rather than for the real-world need of an integrated intervention to simultaneously address multiple CMDs and NCDs; and 2) these interventions have not been studied using implementation strategies that can support easy access (i.e., making care available at or near the patient's home) and sustained implementation in real-world settings. Based on our extensive history and long-term commitment to working in Nepal, we now propose a hybrid implementation-effectiveness study of BECOME (BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases) delivered by community health workers (CHWs) in Nepal. Our team has a long-standing history of conducting implementation research, integrating evidence- based care for CMDs and NCDs into existing health-care systems in Nepal, training CHWs to deliver behavioral interventions at or near patient's homes, and conducting costing analysis. We have an extensive history of collaborating with the Government of Nepal and have a deep understanding of social norms and cultural factors that drive sustained healthcare delivery. The proposed study has three aims to address the gaps identified above: Aim 1) assess the effectiveness of BECOME on depression, anxiety, and two NCDs via a stepped-wedge cluster randomized trial (20 geographic clusters) and participants (n=600) with at least one CMD and one NCD; Aim 2) assess implementation outcomes of BECOME using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework at the patient, provider, and health system levels; and Aim 3) conduct a comprehensive costing analysis to provide strategic inputs to support long-term scale-up of BECOME. If successful, this study will provide evidence and a blueprint to the governments of Nepal and other low-resource settings with an integrated intervention and a set of implementation strategies to deliver behavioral interventions for CMDs and NCDs.