Assessing Cognitive Behavioral Therapy For Insomnia to Improve Sleep Outcomes in Individuals with Concussion (SLiC): A Randomized Delayed Clinical Trial Protocol (Preprint)

BACKGROUND Sleep disturbances post-concussion have been associated with more frequent and severe concussion symptoms and may contribute to poorer recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia, yet it remains unclear if this treatment method is effective in improving sleep outcomes and reducing concomitant post-concussion symptoms in individuals’ post-concussion. OBJECTIVE The hypotheses for this study are 1. CBT-I will improve sleep outcomes and 2. CBT-I will improve concomitant post-concussion METHODS Forty individuals who are ≥four weeks post-concussion injury and have insomnia symptoms will be enrolled in this randomized clinical trial. Participants will be randomized into either: 1. A group that starts a 6-week CBT-I program immediately after baseline or 2. A wait-list control group that starts CBT-I following a 6-week waiting period. All participants will be reassessed after 6, 12, and 18 weeks. Standardized assessments measuring sleep outcomes, post-concussion symptoms, and mood will be used. T-tests and linear regression will be used for statistical analyses. RESULTS It is anticipated that participants will reduce insomnia symptoms and post-concussion symptoms following CBT-I and will maintain these improvements for at least 12 weeks. Additionally, there will be a positive correlation between sleep and post-concussion symptoms. CONCLUSIONS Successful completion of this pilot study will allow for a better understanding of the treatment of insomnia and post-concussion symptoms in individuals following a concussion. CLINICALTRIAL ClinicalTrials.gov NCT04885205