Status:
RECRUITING
Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
Congressionally Directed Medical Research Programs
Hope Health Research Institute
Conditions:
Insomnia
Mild Traumatic Brain Injury
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The purpose of this study is to identify the optimal behavioral treatment for insomnia in service members with comorbid insomnia and prolonged postconcussive symptoms following Mild Traumatic Brain In...
Eligibility Criteria
Inclusion
- 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 based on self-report.
- At least 2 postconcussive symptoms scored \> 2 (moderate) on the Neurobehavioral Symptom Inventory (NSI), with at least 1 of these symptoms from the cognitive domain in addition to the sleep disturbances item.
- Clinically significant chronic insomnia disorder assessed by an independent evaluator using the Structured Clinical Interview for Sleep Disorders-Revised (SCISD-R)\_No Split Week Self-Assessment of Sleep Survey (SASS-Y).
- Minimum score of 15 on the Insomnia Severity Index (ISI).
- Plans to be 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.
Exclusion
- Moderate TBI (e.g., skull fracture, brain hemorrhage, hematoma) indicated by self-report or medical record.
- Any sleep, medical, or psychiatric disorder requiring urgent treatment (e.g., suicide risk, substance use, insomnia with occupational impairment in high risk professions; very short sleep duration of less than 4 hours on average; bipolar disorder or psychosis) or that otherwise interferes with the completion of the baseline assessment.
- Working night shifts (i.e., duty later than 9:00 pm or before 5:30 am) more than 3 times per month.
- Planned major surgery.
- Pregnancy, assessed by self-report and review of medical record.
Key Trial Info
Start Date :
December 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06551987
Start Date
December 3 2024
End Date
September 1 2027
Last Update
January 7 2026
Active Locations (1)
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1
Carl R. Darnall Army Medical Center
Fort Cavazos, Texas, United States, 76544