@article{ref1,
title="A randomized clinical trial for a self-guided sleep intervention following moderate-severe traumatic brain injury: study protocol",
journal="Contemporary clinical trials",
year="2024",
author="Sullan, Molly J. and Kinney, Adam R. and Stearns-Yoder, Kelly A. and Reis, Daniel J. and Saldyt, Emerald G. and Forster, Jeri E. and Cogan, Chelsea M. and Bahraini, Nazanin H. and Brenner, Lisa A.",
volume="ePub",
number="ePub",
pages="ePub-ePub",
abstract="BACKGROUND: Individuals with a history of moderate-severe traumatic brain injury (TBI) experience a significantly higher prevalence of insomnia compared to the general population. While individuals living with TBI have been shown to benefit from traditional insomnia interventions (e.g., face-to-face [F2F]), such as Cognitive Behavioral Therapy for Insomnia (CBTI), many barriers exist that limit access to F2F evidence-based treatments. Although computerized CBT-I (CCBT-I) is efficacious in terms of reducing insomnia symptoms, individuals with moderate-severe TBI may require support to engage in such treatment. Here we describe the rationale, design, and methods of a randomized controlled trial (RCT) assessing the efficacy of a guided CCBT-I program for reducing insomnia symptoms for participants with a history of moderate-severe TBI. <br><br>METHODS: This is an RCT of a guided CCBT-I intervention for individuals with a history of moderate-severe TBI and insomnia. The primary outcome is self-reported insomnia severity, pre- to post-intervention. Exploratory outcomes include changes in sleep misperception following CCBT-I and describing the nature of guidance needed by the Study Clinician during the intervention. <br><br>CONCLUSION: This study represents an innovative approach to facilitating broader engagement with an evidence-based online treatment for insomnia among those with a history of moderate-severe TBI. <br><br>FINDINGS will provide evidence for the level and nature of support needed to implement guided CCBT-I. Should findings be positive, this study would provide support for a strategy by which to deliver guided CCBT-I to individuals with a history of moderate-severe TBI.<p /> <p>Language: en</p>",
language="en",
issn="1551-7144",
doi="10.1016/j.cct.2024.107525",
url="http://dx.doi.org/10.1016/j.cct.2024.107525"
}