Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
Cognitive Behavioral Therapy for Insomnia vs Brief Behavioral Therapy for Insomnia in Military Personnel With Postconcussive Symptoms Following Mild Traumatic Brain Injury
Who can join
Ages 18 to 45 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
About the study
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).
What is being tested
- Cognitive Behavioral Therapy for Insomnia (behavioral)
- Brief Behavioral Therapy for Insomnia (behavioral)
Sponsor: The University of Texas Health Science Center at San Antonio · Participants: 160 · Started: Dec 3, 2024
Contact the study team
- Isabella McElwain, B.S. · Phone: 254-226-6987
- Kristi E. Pruiksma, Ph.D. · Phone: 210 562 6700
Official record on ClinicalTrials.gov — NCT06551987
Locations in the U.S.
| Texas | Carl R. Darnall Army Medical Center, Fort Cavazos |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.