NCT07385105 Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
| NCT ID | NCT07385105 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Missouri-Columbia |
| Condition | Sleep Architecture |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2026-03-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07385105 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Sleep Architecture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07385105 currently recruiting?
Yes, NCT07385105 is actively recruiting participants. Contact the research team at sznmx@missouri.edu for enrollment information.
Where is the NCT07385105 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT07385105 clinical trial?
NCT07385105 is sponsored by University of Missouri-Columbia. The trial plans to enroll 15 participants.