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NCT07385105NARecruiting

Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)

University of Missouri-Columbia

Start Date

3/1/2026

Completion Date

1/1/2027

Summary

This study will employ cognitive behavioral therapy for insomnia (CBT-I) among individuals with mild traumatic brain injury (mTBI) who experience sleep disturbances. The research aims to evaluate the effects of CBT-I on sleep, mTBI symptoms, and, in particular, the ability of individuals with mTBI to engage in their desired daily life activities. The main questions this study aims to answer are: 1. Does CBT-I positively impact symptoms of mTBI? 2. Does CBT-I improve functional performance in individuals with mTBI?

Detailed Description

Cognitive behavioral therapy for insomnia (CBT-I) is an evidence-based intervention that has demonstrated significant results in various populations. CBT-I is a structured and goal-oriented approach that addresses both unhelpful thoughts and maladaptive behaviors contributing to poor sleep. CBT-I includes several components, such as behavioral strategies that aim to change habits disrupting sleep architecture and cognitive techniques targeting maladaptive beliefs about sleep. However, limited research has examined the use of this intervention among individuals with mild traumatic brain injury (mTBI), particularly regarding its impact on their ability to perform daily life activities. This study aims to evaluate how CBT-I can impact sleep, mTBI symptoms, and participants' functional performance.

Eligibility Criteria

Age Range: 18 years to 60 years

Inclusion Criteria: * A history of mTBI documented by a physician and sleep problems for more than 4 weeks * A score ≥ 10 on the Insomnia Severity Index (ISI) * Speak, read, and write English Exclusion Criteria: * History of other neurological or psychological conditions * Patient Health Questionnaire-9 (PHQ-9) score higher than 20 (severe depressive symptoms) * Generalized Anxiety Disorder-7 (GAD-7) score higher than 15 (severe anxiety symptoms) * Montreal Cognitive Assessment (MoCA) score less than 24

Interventions

BEHAVIORAL

Cognitive behavioral Therapy for insomnia (CBT-I)

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Conditions

Sleep ArchitectureMild Traumatic Brain InjurySleepSleep and Circadian Problems

Locations

University of Missouri-Columbia

Columbia, Missouri 65211

United States