Protocol for the Project SAVE randomised controlled trial examining CBT for insomnia among veterans in treatment for alcohol use disorder

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BMJ Open. 2021 Jun 8;11(6):e045667. doi: 10.1136/bmjopen-2020-045667.

ABSTRACT

INTRODUCTION: As many as 74% of veterans with alcohol use disorders (AUDS) report symptoms of insomnia. Insomnia represents a barrier to alcohol treatment because insomnia symptoms (1) may lead to relapse among those who use alcohol to help them sleep and may negatively impact (2) executive functions and (3) emotion regulation skills. Cognitive-behavioural therapy for insomnia (CBT-I) is an efficacious first-line treatment for insomnia; however, no research has examined the impact of CBT-I on individuals’ response to alcohol treatment. In the Sleep and Alcohol for Veterans (Project SAVE) randomised controlled trial, we hypothesise that CBT-I will enhance the efficacy of alcohol treatment among Veterans with insomnia by enhancing their abilities to attend to treatment, regulate emotions and initiate sleep without alcohol.

METHODS AND ANALYSIS: Eighty Veterans enrolled in alcohol treatment at the Veterans Administration (VA) hospital will be randomly assigned to receive either CBT-I or single-session sleep hygiene (SH) education. Individuals will be eligible to participate if they meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for moderate to severe AUD and Insomnia Disorder of at least 1-month duration. Participants will complete assessments at baseline, post-treatment and 6-week follow-up. Preliminary process outcomes include retention/recruitment rates and treatment satisfaction (feasibility and acceptability, respectively). Primary outcomes are insomnia severity, percentage of heavy-drinking days and alcohol-related problems. We will assess a variety of secondary clinical and mechanistic outcomes (eg, post-traumatic stress disorder (PTSD) symptoms, attention and working memory).

ETHICS AND DISSEMINATION: Ethics approval was obtained in October 2018. Data collection began in July 2019 and is planned for completion by July 2021. Trial results will be disseminated at local and national conferences, in peer-reviewed publications and through media outlets, as available. Results will also be shared with interested participants and clinical collaborators at the end of the trial.

TRIAL REGISTRATION NUMBER: clinicaltrials.gov identifier NCT03806491 (pre-results).

PMID:34103317 | DOI:10.1136/bmjopen-2020-045667