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

Rebecca Ludwig, Michael Rippee, Linda J D'Silva, Jeff Radel, Aaron M Eakman, Jill Morris, Michelle Drerup, Catherine Siengsukon, Rebecca Ludwig, Michael Rippee, Linda J D'Silva, Jeff Radel, Aaron M Eakman, Jill Morris, Michelle Drerup, Catherine Siengsukon

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://ichgcp.net/clinical-trials-registry/NCT04885205.

International registered report identifier (irrid): DERR1-10.2196/38608.

Keywords: CBT; RCT; brain; cognitive behavioral therapy; concussion; injury; insomnia; pilot study; protocol; randomized controlled trial; recovery; sleep.

Conflict of interest statement

Conflicts of Interest: CS is the owner and chief executive officer of Sleep Health Education, LLC.

©Rebecca Ludwig, Michael Rippee, Linda J D’Silva, Jeff Radel, Aaron M Eakman, Jill Morris, Michelle Drerup, Catherine Siengsukon. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.09.2022.

Figures

Figure 1
Figure 1
Study flowchart. CBT-I: cognitive behavioral therapy for insomnia.

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