Assessing Cognitive Behavioral Therapy for Insomnia to Improve Sleep Outcomes in Individuals With a Concussion: Protocol for a Delayed Randomized Controlled Trial

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; however, it remains unclear if this treatment method is effective in improving sleep outcomes and reducing concomitant postconcussion symptoms. Objective The hypotheses for this study are that (1) CBT-I will improve sleep outcomes and (2) CBT-I will improve concomitant postconcussion symptoms. Methods In total, 40 individuals who are within ≥4 weeks of postconcussion injury and have insomnia symptoms will be enrolled in this randomized controlled trial. Participants will be randomized into either a group that starts a 6-week CBT-I program immediately after baseline or a waitlist control group that starts CBT-I following a 6-week waiting period. All participants will be reassessed 6, 12, and 18 weeks after baseline. Standardized assessments measuring sleep outcomes, postconcussion symptoms, and mood will be used. Linear regression and t tests will be used for statistical analyses. Results Enrollment of 40 participants was completed July 2022, data collection will be completed in November 2022, and publication of main findings is anticipated in May 2023. It is anticipated that participants experience reduced insomnia symptoms and postconcussion symptoms following CBT-I and these improvements will be retained for at least 12 weeks. Additionally, we expect to observe a positive correlation between sleep and postconcussion symptom improvement. Conclusions Successful completion of this pilot study will allow for a better understanding of the treatment of insomnia and postconcussion symptoms in individuals following a concussion. Trial Registration ClinicalTrials.gov NCT04885205; https://clinicaltrials.gov/ct2/show/NCT04885205 International Registered Report Identifier (IRRID) DERR1-10.2196/38608

Cognitive Behavioral Therapy for Insomnia Improves Sleep Outcomes in Individuals With Concussion: A Preliminary Randomized Wait-List Control Study

“…Detailed methods, which are described below, for this study can be found in Ludwig et al 16 This study was approved by the Institutional Review Board at the University of Kansas Medical Center. Prior to study procedures, individuals completed an informed consent process.…”

“…Study flow. From Ludwig et al16 Originally published in JMIR Research Protocols (https://www.researchprotocols.org), September 23, 2022. Published (and can be reproduced) under the terms of Creative Commons Attribution 4.0 license (or 2.0 prior to mid-May 2017).…”

“…Each weekly session started with a discussion on the previous week of sleep, review of the sleep diary, and the prior week's goals. The session outlines are described in detail in Ludwig et al 16 Periodically throughout the study, R.L. met with 2 study team members who are Diplomats in Behavioral Sleep Medicine (DBSM) for quality assurance (M.D.…”