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

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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.