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

由社区卫生工作者开展的 BECOME（基于行为社区的心理健康和非传染性疾病联合干预措施）的 II 型混合实施效果研究

• 批准号: 10658312
• 负责人: Bibhav Acharya
• 金额: $ 66.41万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10658312
• 关键词: Address; Anxiety; Attitude; Behavior; Behavior Therapy; Behavioral; Blood Pressure; Caring; Cause of Death; Cessation of life; Clinical Protocols; Cluster randomized trial; Collaborations; Communities; Community Health Aides; Complex; Cost Analysis; Diabetes Mellitus; Diet; Disease; Effectiveness; Face; Funding; Geography; Government; Guidelines; Health system; Healthcare; Healthcare Systems; Heterogeneity; Home; Hypertension; Intervention; Intervention Studies; Leadership; Life Style Modification; Mental Depression; Mental Health; Mental disorders; Methods; Mobile Health Application; Motivation; Nepal; Participant; Patient Recruitments; Patients; Persons; Pharmaceutical Preparations; Physical activity; Policy Maker; Provider; Psychotherapy; Public Health; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Recording of previous events; Reporting; Research; Resource-limited setting; Risk Factors; Risk Reduction; Severities; Site; Stress; Testing; Time; Tobacco; Tobacco use; Training; United States National Institutes of Health; Work; World Health Organization; anxiety symptoms; beneficiary; comorbidity; cost; cost effective; depressive symptoms; disability; effectiveness evaluation; effectiveness testing; effectiveness/implementation study; evidence base; experience; fasting glucose; follow-up; health care delivery; implementation barriers; implementation evaluation; implementation outcomes; implementation research; implementation strategy; improved; innovation; low and middle-income countries; motivational enhancement therapy; primary care provider; primary outcome; risk sharing; scale up; secondary outcome; skills; social norm; sociocultural determinant; stress reduction; symposium; time use; treatment adherence

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.

项目摘要 常见的心理健康障碍（CMD），如抑郁症和焦虑症，以及非传染性疾病 糖尿病和高血压等非传染性疾病非常普遍，是死亡的主要原因， 世界各地的残疾人，特别是在像我们在尼泊尔的研究网站这样的低资源环境中。共病 慢性病和非传染性疾病的发病率很高，这些疾病之间的关系是复杂和多方面的。 一些常见的行为风险因素使这两种情况恶化：压力，孤立，吸烟，低体力 活动、低质量饮食和治疗依从性差。行为干预可以解决这些常见的 风险因素，并改善CMD和NCD。世界卫生组织（WHO）的两项临床协议， CMD和NCD推荐了三种行为干预措施：a）循证减压（EBSR）， 压力/焦虑; B）抑郁症的行为激活（BA）;以及c）健康人的动机访谈（MI） 行为。尽管有这种潜力，但这些干预措施在资源匮乏的环境中很少可用，因为 两个重要的差距：1）行为干预经常被研究用于一种或两种CMD和NCD， 而不是为了同时解决多种CMD的综合干预的现实需要， 非传染性疾病; 2）这些干预措施没有使用可以支持容易的实施战略进行研究 访问（即，在患者家中或附近提供护理），并在现实世界中持续实施 设置.基于我们在尼泊尔的悠久历史和长期工作承诺，我们现在提出一项 BECOME口腔社区综合干预混合实施效果研究 精神卫生和非传染性疾病），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- 将慢性病和非传染性疾病的基础护理纳入尼泊尔现有的卫生保健系统， 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 与尼泊尔政府合作的历史，并对社会规范和 推动持续医疗保健服务的文化因素。拟议的研究有三个目标，以解决 目标1）评估BECOME对抑郁症、焦虑症和两种NCD的有效性， 一项阶梯楔形分组随机试验（20个地理分组），参与者（n=600） CMD和一个NCD;目标2）使用覆盖范围、有效性、 患者、提供者和卫生系统的采用、实施和维护（RE-AIM）框架 水平;和目标3）进行全面的成本分析，以提供战略投入来支持长期 成为的规模。如果成功，这项研究将为各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， 为CMD和NCD提供行为干预。