Cognitive behavioral therapy for insomnia in people with mild traumatic brain injury
Exploring Cognitive Behavioral Therapy for Insomnia (CBT-I) in Mild Traumatic Brain Injury (mTBI)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT07385105 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Columbia, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.