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.

抽象的 失眠，在15-25％的低收入成年人和其他社会经济上的重叠 诸如种族/族裔少数民族之类的弱势群体经常被低估，损害生活质量，并且是 与增加抑郁症，心血管疾病和过早死亡的风险增加有关。我们的长期 目标是测试对失眠的传播和实施循证治疗 面临失眠症不平等的社会经济处境不利的成年人。认知行为疗法 建议将失眠症（CBTI）作为一线治疗。但是，CBTI的实际采用受到限制 受少数受过训练的临床医生，治疗时间，成本和语言障碍。简短的 开发了失眠（BBTI）的行为治疗，以减少燃烧时间来扩大CBTI的影响 （1.5 vs6小时）治疗和临床训练，同时利用宽阔的劳动力并嵌入 常规医疗设置的付款模型，例如初级保健。那，BBTI为 将CBTI的核心行为组成部分交付给受到社会经济困扰的患者，他们面对 访问CBTI的最大障碍，在失眠研究中的代表性不足。这项研究是 得到证明BBTI在改善失眠症结果方面的短期效率的证据支持。然而， BBTI的效果尚未与CBTI相比。此申请提案通过测试来填补此空白 与CBTI相比，与CBTI相比，在低收入中的失眠和与失眠有关的结果相比 单个站点的社区和基于学术的初级诊所接受护理的样本不同。期间 我们将在一年的R61启动阶段进行基础工作，以确保R33临床试验阶段是 迅速且最佳地启动，以有效地吸引所有伴侣和我们的目标患者人群 并遇到招聘里程碑。 R33阶段由52周的有效性试验组成 招募350名失眠症患者有资格通过医疗获得保险的患者 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 该BBTI将不在CBTI（由失眠严重程度的4分定义） 索引）3个月。次要结果将包括生活质量；沮丧;和日记报告的睡眠 持续时间和效率；催眠使用；和不利事件。我们还将探索6和6时的效果耐用性 12个月。我们将使用合并的框架进行实施研究来探索患者和 诊所层面的上下文因素会影响实施以告知未来策略。通过同时测试 有效性和调查实施因素，该提案将奠定后续的基础 实施试验测试了基于证据的行为失眠治疗的广泛吸收。那， 为拟议的工作获得的信息将直接推动失眠的治疗 沿翻译连续体的小组与此RFA的目标密切一致。