Cognitive behavioral therapy for insomnia in people with mild traumatic brain injury
Official title: Exploring Cognitive Behavioral Therapy for Insomnia (CBT-I) in Mild Traumatic Brain Injury (mTBI)
Run by University of Missouri-Columbia · NCT07385105 · Data updated 2026-11-12
This study will try cognitive behavioral therapy for insomnia (CBT-I) to see if it helps adults with mild traumatic brain injury sleep better and improve daily functioning.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | May 30, 2027 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07385105 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a physician-documented history of mild traumatic brain injury, English fluency, sleep problems lasting more than four weeks, and an ISI score of 10 or higher who do not have severe depression or anxiety and have a MoCA score of 24 or above.
✕Probably not a fit
People with other neurological or significant psychiatric conditions, severe depressive or anxiety symptoms (PHQ-9 >20 or GAD-7 >15), substantial cognitive impairment (MoCA <24), or without clinically significant insomnia (ISI <10) are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center interventional study will deliver a structured CBT-I program to adults with a documented history of mild traumatic brain injury who have had sleep problems for more than four weeks and an Insomnia Severity Index (ISI) score of 10 or higher. The intervention uses behavioral strategies and cognitive techniques to change sleep-disrupting habits and unhelpful beliefs about sleep. Key outcome measures include sleep metrics, mTBI symptom change, and functional performance in daily activities, with common exclusions for severe depression, severe anxiety, other neurologic/psychological disorders, or MoCA scores below 24. The trial is conducted at the University of Missouri–Columbia and collects pre- and post-intervention data to compare changes over time.
Why it matters
Potential benefit: If successful, CBT-I could improve sleep quality and help people with mTBI function better in their daily lives while reducing some mTBI-related symptoms.
How similar studies have gone: CBT-I is an evidence-based treatment that has produced strong results in many populations, but its effects specifically in individuals with mTBI have been studied only limitedly.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Missouri-Columbia
Columbia, Missouri, United States Recruiting
Study contacts
- Study coordinator: Sepideh Zenoozi, PhD student
- Email: sznmx@missouri.edu
- Phone: 573-823-3082
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.