RecruitingNot ApplicableNCT07385105

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

Exploring Cognitive Behavioral Therapy for Insomnia (CBT-I) in Mild Traumatic Brain Injury (mTBI)


Sponsor

University of Missouri-Columbia

Enrollment

15 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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?


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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

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Interventions

BEHAVIORALCognitive behavioral Therapy for insomnia (CBT-I)

CBT-I is an evidence-based psychotherapy designed to address insomnia. This structured and multifaceted intervention aims to help individuals who have trouble falling asleep or/ and staying asleep during the night. CBT-I is a multi-component treatment that includes two core parts: behavioral and cognitive aspects. It consists of Sleep Restriction Therapy (SRT), Stimulus Control Therapy (SCT), and Cognitive Therapy (CT) with an emphasis on Cognitive restructuring, as well as Psychoeducation and Sleep Hygiene Education. Each CBT-I session has a clear structure and includes various components such as assessment, psychoeducation, behavioral and cognitive interventions, adherence monitoring, and strategies for preventing relapse. In this study, participants will receive CBT-I in a one-on-one setting, meeting on Zoom once a week for six weeks, and each session will last an hour.


Locations(1)

University of Missouri-Columbia

Columbia, Missouri, United States

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NCT07385105


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