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A randomized clinical trial for a self-guided sleep intervention following moderate-severe traumatic brain injury: Study protocol.
- Source :
-
Contemporary Clinical Trials . Jun2024, Vol. 141, pN.PAG-N.PAG. 1p. - Publication Year :
- 2024
-
Abstract
- 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 (CBT I), 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. 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. 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. 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. • There is a high prevalence of sleep disorders, including insomnia, following moderate-severe traumatic brain injury (TBI). • Computerized Cognitive Behavioral Therapy for Insomnia (CCBT-I) may help address barriers to accessing traditional treatments for insomnia. • Individuals with moderate-severe TBI often have impairments that may interfere with the uptake of CCBT-I. • Provider supported CCBT-I may increase efficacy of CCBT-I among some cohorts, such as those with a history of moderate-severe TBI. • This is a randomized controlled trial of a CCBT-I intervention for individuals with current insomnia and a history of moderate-severe TBI. • Positive results could support the development of a stepped-care model of CCBT-I following moderate-severe TBI. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 15517144
- Volume :
- 141
- Database :
- Academic Search Index
- Journal :
- Contemporary Clinical Trials
- Publication Type :
- Academic Journal
- Accession number :
- 177224197
- Full Text :
- https://doi.org/10.1016/j.cct.2024.107525