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

摘要 15-25%的低收入成年人和其他社会经济重叠的人中存在这种情况。 弱势群体，如种族/族裔少数群体，往往得不到充分的治疗，损害生活质量， 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 目的是测试失眠症循证治疗的传播和实施， 社会经济上处于不利地位的成年人面临失眠护理不平等。的认知行为疗法的 失眠症（CBTI）被推荐为一线治疗。然而，CBTI在现实世界中的采用受到限制， 由有限数量的经过专业培训的临床医生进行，治疗时间，费用和语言障碍。简要 开发了失眠行为治疗（BBTI），以通过减少时间负担来扩大CBTI的范围 (1.5与206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提供了一个可扩展的解决方案， 将CBTI的核心行为组件提供给社会经济上处于不利地位的患者， 这是获得CBTI的最大障碍，在失眠研究中代表性不足。本研究 有证据表明BBTI在改善失眠方面的短期疗效。然而，在这方面， BBTI的效果尚未与CBTI进行充分比较。本申请建议通过测试来填补这一空白 在低收入人群中，BBTI与CBTI相比在失眠和失眠相关结局方面的非劣效性， 在单一地点的社区和学术性初级诊所接受护理的不同样本。期间 在为期一年的R61启动阶段，我们将开展基础工作，以确保R33临床试验阶段 快速启动并优化结构，以有效地吸引所有合作伙伴和我们的目标患者人群 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 招募了350名有资格通过医疗保险获得保险的失眠症初级保健患者 援助计划（例如，医疗补助），讲西班牙语，或代表种族或少数民族。我们假设 BBTI将非劣效于CBTI（定义为失眠严重程度的非劣效性界值为4分 指数）。次要结果将包括生活质量、抑郁和日记报告的睡眠 持续时间和效率;催眠药的使用;以及不良事件。我们还将探索6岁时效果的持久性， 12个月我们将使用实施研究的综合框架来探索患者和 影响实施的临床水平背景因素，以告知未来的战略。通过同时测试 有效性和调查实施因素，这一建议将奠定基础， 实施试验测试广泛采用循证行为失眠治疗。因此 为拟议的工作获得的信息将直接促进失眠的治疗， 沿着翻译连续体分组，与本RFA的目标高度一致。

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.