RCT of the Effectiveness of Stepped-Care Sleep Therapy In General Practice (RESTING)

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Insomnia and use of sleep medications increase around age 50 and affect approximately one in three middle aged and older adults. Untreated insomnia is associated with a range of negative sequelae, including several, such as visual impairment, cognitive impairment, imbalance, and greater risk for falls that are specific to this older age group. In primary care, insomnia is treated with hypnotics; but even the newer and safer hypnotics are associated with cognitive impairment and risk of falls. Cognitive behavioral therapy for insomnia (CBTi) offers a viable alternative to hypnotic medications and could reduce their use, as recommended by the American Geriatric Society Beers Criteria. CBTi is a brief insomnia-focused psychotherapy that is as efficacious as a variety of hypnotic medications in the short-term and superior over the long-term. Although it is the recommended first line treatment for insomnia by the American College of Physicians, access to this safe and effective treatment is limited by current models of therapist-led delivery. Broad long term objectives: This proposal aims to fill in the science-to-service gap between proven efficacy of CBTi and future large scale implementation. We have developed and propose to test a primary-care-friendly stepped-care CBTi model (STEPPED CARE) that offers an easy to use Decision Checklist for matching delivery of CBTi to individual patient characteristics so that patients will begin treatment with the appropriate delivery mode. Specific aims: We propose to compare STEPPED CARE to an ONLINE ONLY program. We will focus on comparative effectiveness (Aims 1) and testing the Decision Checklist (Aim 2), as well as evaluating other aspects of the two-steps STEPPED CARE program, including the specific Checklist Criteria and the added benefit of the second step for those with insufficient response to the first step (Aim 3). We will perform a rigorous mixed-methods formative evaluation to guide future implementation and dissemination potential (Aim 4). Results will yield a simple and effective way for primary care providers to prescribe CBTi to middle aged and older adults. Methods: Participants will be randomized to receive ONLINE ONLY or STEPPED CARE CBTi. Primary outcomes are insomnia severity and the amount of hypnotic medications used, assessed over a 12 month period. A mix of quantitative and qualitative methods will be used to collect data from multiple steak-holders about the potential for reach, adoption, implementation, and maintenance of the two approaches. Impact: The proposed STEPPED CARE model for delivering CBTi has the potential to improve sleep, reduce use of hypnotic medication, and promote safety and wellbeing of middle aged and older adults. Importantly, it offers convenient access to treatment for patients, while using resources efficiently. Efficient use of resources will result from provision of the less expensive online CBTi as a first line of treatment to those who are likely to benefit from it so that the limited therapist-led treatment resources can be focused on patients who are less likely to benefit from online CBTi and to those for whom online treatment was unsuccessful.