Cognitive-behavioural therapy for insomnia in adults to decrease cannabis use: study protocol for a randomised controlled trial in a community sample of adults with frequent cannabis use

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INTRODUCTION: Cannabis use is common in the USA and is associated with adverse outcomes across many domains, including sleep difficulties. Targeting insomnia with an evidence-based treatment could improve sleep and reduce frequent cannabis use. This randomised controlled trial (RCT) will compare evidence-based telemedicine-delivered cognitive-behavioural therapy for insomnia for adults with frequent cannabis use (CBTi-CB) against an active comparator, sleep hygiene education (SHE), for improving insomnia/sleep, associated daytime symptoms and cannabis use. The study will also determine the effects of treatment on sleep mechanisms and their association with clinical outcomes. METHODS AND ANALYSIS: This is a single-site RCT with planned enrolment of 200 adults (21+ years of age) who meet criteria for both chronic insomnia and frequent cannabis use. Eligible participants will be randomised 1:1 to six sessions of CBTi-CB or SHE with clinical assessments conducted at pre-treatment, post-treatment and at 3 and 6 months post-treatment. Overnight polysomnography (PSG) will be conducted before and after treatment. Primary outcomes will include the Insomnia Severity Index, 12-item Short-Form Health Survey Mental Composite Score and cannabis use frequency as assessed by the interview-administered Timeline Follow Back. Electroencephalogram delta activity, derived from overnight PSG, will be the primary end point to assess the sleep homeostasis mechanism. ETHICS AND DISSEMINATION: Ethical approval for the study has been obtained from the Institutional Review Board of the University of Michigan Medical School (IRBMED #HUM00222302). The results of the investigation will be published in scientific papers. The data from the investigation will be made available through the National Institutes of Health (NIH) National Data Archive, which allows researchers on NIH grants to share and access raw data. TRIAL REGISTRATION NUMBER: NCT05814822.

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