Actively Recruiting
Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-01-07
160
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single site, two-armed random controlled trials (RCT) comparing six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I) in service members with comorbid insomnia and prolonged postconcussive symptoms present for at least 3 months after Mild Traumatic Brain Injury (mTBI).
CONDITIONS
Official Title
Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active duty U.S. military service members.
- At least 18 years of age.
- Ability to provide informed consent and follow study-related instructions.
- Self-report of a Mild Traumatic Brain Injury (mTBI) at least 3 months prior to enrollment.
- At least 2 postconcussive symptoms scored > 2 on the Neurobehavioral Symptom Inventory, including at least 1 cognitive symptom and sleep disturbance.
- Clinically significant chronic insomnia disorder assessed by an independent evaluator.
- Minimum score of 15 on the Insomnia Severity Index.
- Plans to remain in the area for the next 3 months.
- Stable on psychotropic and hypnotic medications for at least 1 month.
- Stable on continuous positive airway pressure therapy if diagnosed with sleep apnea for at least 1 month.
You will not qualify if you...
- Moderate traumatic brain injury (e.g., skull fracture, brain hemorrhage, hematoma).
- Any sleep, medical, or psychiatric disorder requiring urgent treatment or interfering with study completion.
- Working night shifts more than 3 times per month.
- Planned major surgery.
- Pregnancy as assessed by self-report and medical record review.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Carl R. Darnall Army Medical Center
Fort Cavazos, Texas, United States, 76544
Actively Recruiting
Research Team
I
Isabella McElwain, B.S.
CONTACT
K
Kristi E. Pruiksma, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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