A hybrid effectiveness-implementation trial evaluating behavioral treatments for insomnia for socioeconomic disadvantaged adults in primary care

一项混合有效性实施试验，评估初级保健中社会经济弱势成年人的失眠行为治疗方法

• 批准号: 10507411
• 负责人: Suzanne Bertisch
• 金额: $ 56.3万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10507411
• 关键词: Address; Administrator; Adoption; Adult; Adverse event; Behavior Therapy; Behavioral; Biometry; Cardiovascular Diseases; Cardiovascular system; Caring; Clinic; Clinical; Clinical Research; Clinical Trials; Cognitive Therapy; Communities; Consolidated Framework for Implementation Research; Data; Data Collection; Diagnosis; Dissemination and Implementation; Effectiveness; Employee; Enrollment; Ensure; Evidence based treatment; Face; Foundations; Future; Goals; Guidelines; Health; Hospitals; Hour; Household; Impaired cognition; Impairment; Income; Infrastructure; Insurance; Intervention; Interview; Knowledge; Language; Low income; Major Depressive Disorder; Medicaid; Medical; Medical Assistance; Mental Depression; Mental Health; Modeling; Nurse Practitioners; Outcome; Participant; Patient Care; Patients; Persons; Pharmacotherapy; Phase; Physician Executives; Premature Mortality; Preventive; Primary Health Care; Protocols documentation; Quality of life; Randomized; Recommendation; Recording of previous events; Reporting; Research; Research Design; Risk; Risk Factors; Sampling; Severities; Site; Sleep; Sleep Disorders; Sleeplessness; Social Workers; Structure; Symptoms; Telephone; Testing; Time; Training; Underserved Population; United States; Woman; Work; acceptability and feasibility; adverse outcome; arm; base; burden of illness; cardiovascular disorder risk; contextual factors; cost; diaries; effectiveness implementation study; effectiveness implementation trial; effectiveness testing; ethnic minority; ethnic minority population; evidence base; experience; future implementation; health inequalities; health related quality of life; hypnotic; implementation determinants; implementation science; implementation trial; improved; indexing; informant; medical specialties; mortality; multidisciplinary; nondrug therapy; patient population; payment; physical conditioning; pilot test; post intervention; primary care setting; primary outcome; programs; racial and ethnic; racial minority; randomized effectiveness trial; randomized trial; recruit; secondary outcome; side effect; sleep health; sleep quality; socioeconomic disadvantage; telehealth; treatment comparison; uptake

ABSTRACT Insomnia, present among 15-25% of low-income adults and other overlapping socioeconomically disadvantaged groups such as racial/ethnic minorities, is frequently undertreated, impairs quality of life, and is associated with increased risk for depression, cardiovascular disease, and premature mortality. Our long-term goal is to test the dissemination and implementation of evidence-based treatments for insomnia for socioeconomically disadvantaged adults who face insomnia care inequities. Cognitive-behavioral therapy for insomnia (CBTI) is recommended as first-line treatment. However, CBTI’s real-world adoption is constrained by a limited number of specialty-trained clinicians, treatment time, costs, and language barriers. Brief behavioral treatment for insomnia (BBTI) was developed to expand CBTI’s reach by reducing the time burden (1.5 vs  6 hours) of treatment and clinician training while harnessing the broad workforce and embedded payment models of routine medical settings, such as primary care. Thus, BBTI offers a scalable solution for delivering CBTI’s core behavioral components to socioeconomically disadvantaged patients, who face the greatest barriers to accessing CBTI and have been underrepresented in insomnia research. This study is supported by evidence demonstrating BBTI’s short-term efficacy in improving insomnia outcomes. However, BBTI’s effects have not been adequately compared to CBTI. This application proposes to fill this gap by testing the non-inferiority of BBTI compared to CBTI on insomnia and insomnia-related outcomes in a low-income, diverse sample receiving care in community and academic-based primary clinics across a single site. During the one-year R61 start-up phase, we will conduct foundational work to ensure the R33 clinical trial phase is launched expeditiously and optimally structured to efficiently engage all partners and our target patient population and meet recruitment milestones. The R33 phase consists of a 52-week effectiveness-implementation trial enrolling 350 primary care patients with insomnia who are eligible to receive insurance through a medical assistance program (e.g., Medicaid), speak Spanish, or represent a racial or ethnic minority. We hypothesize that BBTI will be non-inferior to CBTI (defined by a non-inferiority margin of 4 points on the insomnia severity index) at 3-months. Secondary outcomes will include quality-of-life; depression; and diary-reported sleep duration and efficiency; hypnotic use; and adverse events. We will also explore the durability of effects at 6 and 12 months. We will use the Consolidated Framework for Implementation Research to explore patient- and clinic-level contextual factors influencing implementation to inform future strategies. By concurrently testing the effectiveness and investigating implementation factors, this proposal will lay the foundation for subsequent implementation trials testing the broad uptake of evidence-based behavioral insomnia treatments. Thus, the information gained for the proposed work would directly advance the treatment of insomnia for underserved groups along the translational continuum, strongly aligning with the goals of this RFA.

摘要 失眠，出现在15%-25%的低收入成年人和其他重叠的社会经济领域 弱势群体，如种族/少数民族，往往得不到充分的对待，损害生活质量，而且 与抑郁症、心血管疾病和过早死亡的风险增加有关。我们的长期合作 目标是测试失眠循证治疗的传播和实施情况 面临失眠护理不平等的社会经济弱势成年人。认知行为疗法 建议将失眠(CBTI)作为一线治疗。然而，CBTI在现实世界中的采用受到限制 由于受过专业训练的临床医生数量有限，治疗时间、成本和语言障碍。简介 失眠的行为治疗(BBTI)是为了通过减少时间负担来扩大CBTI的覆盖范围 (1.5vs.6小时)的治疗和临床医生培训，同时利用广泛的劳动力和嵌入式 常规医疗机构的支付模式，如初级保健。因此，BBTI为以下方面提供了可扩展的解决方案 向社会经济困难的患者提供CBTI的核心行为组件，他们面临着 获得CBTI的最大障碍，在失眠研究中一直被低估。这项研究是 有证据表明BBTI在改善失眠结果方面短期有效。然而， BBTI的影响还不足以与CBTI相提并论。此应用程序建议通过测试来填补这一空白 在低收入人群中，与CBTI相比，BBTI在失眠和失眠相关结果方面并不逊色， 在单一地点的社区和以学术为基础的初级诊所接受治疗的不同样本。在.期间 为期一年的R61启动阶段，我们将进行基础性工作，以确保R33临床试验阶段 迅速推出，结构优化，有效吸引所有合作伙伴和我们的目标患者群体 并达到招聘里程碑。R33阶段包括为期52周的有效性实施试验 纳入350名有资格通过医疗保险获得保险的初级保健失眠患者 援助计划(例如，医疗补助)，会说西班牙语，或代表种族或少数民族。我们假设 BBTI将不逊于CBTI(由失眠严重程度4分的非劣势差值定义 指数)为3个月。次要结果将包括生活质量、抑郁和日记报道的睡眠。 持续时间和效率；催眠使用；以及不良事件。我们还将探索6点和6点效果的耐久性 12个月。我们将使用实施研究综合框架来探索患者和 影响实施的临床层面的背景因素，以便为未来的战略提供信息。通过同时测试 并对实施效果和影响因素进行调查，为后续工作奠定基础 实施试验，测试基于证据的行为失眠治疗的广泛接受性。因此， 为拟议工作获得的信息将直接推动对服务不足的失眠症的治疗 小组沿着翻译连续体，强烈地与本RFA的目标保持一致。