Assessing The Feasibility and Acceptability of A Cluster-Randomized Study of Cognitive Behavioral Therapy For Chronic Insomnia In A Primary Care Setting

Abstract Background: Cognitive behavioral therapy (CBT) is the treatment of choice for chronic insomnia but is underutilized in patients in primary care. The purpose of this study was to assess the feasibility and acceptability of a pilot cluster-randomized study of CBT for chronic insomnia (CBT-i) in a primary care setting. Methods: This pilot-feasibility study with a parallel cluster-randomized design comparing CBT-i-intervention group (IG) and usual care (UC) was performed at two primary health care centers in Majorca, Spain. Patients were included if they were 18 to 65 years-old; had diagnoses of chronic insomnia according to the Insomnia Severity Index (ISI ³ 8) and had insomnia longer than 3 months; and did or did not use a hypnotic medication. A total of 25 GPs and nurses and 32 patients were randomly allocated to two groups. The outcome of the intervention was improvement in quality of sleep. Other primary outcomes were the feasibility and applicability of the intervention, which were defined using nominal groups. UC was defined based on previous studies. The recruitment process, compliance with intervention sessions, and patient retention were also assessed.Results: We adapted the CBT-i approach of Morin to a primary care context. After intervention training, primary care providers (PCPs) expressed the need for more extensive training in the different aspects of the therapy and the discussion of more cases. PCPs considered the intervention as adequate but wanted fewer and shorter sessions as well as to discard the cognitive restructuring component. PCPs considered it crucial to prepare each session in advance and to establish a specific agenda for the CBT-i. Regular reminders given to PCPs and patients were suggested to improve study participation. Compared to the UC group, significantly higher proportions of patients in the IG had short sleep latency, slept for longer than 5 h, and had fewer sleep disruptions. Conclusions: This pilot-feasibility study identified several key issues that must be addressed before performing CBT-i intervention in future clinical trials in a primary care setting. Trial registration: NCT04565223. (Clinical trials.gov) Registered 1 September 2020 - Retrospectively registered.