Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 8, 2022
Date Accepted: Aug 29, 2022
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Assessing Cognitive Behavioral Therapy For Insomnia to Improve Sleep Outcomes in Individuals with Concussion (SLiC): A Randomized Delayed Clinical Trial Protocol
ABSTRACT
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. Clinical Trial: ClinicalTrials.gov NCT04885205
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