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RecruitingInsomniaMild Traumatic Brain Injury

Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

Eligible age

18–45 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this 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).

Sponsor: The University of Texas Health Science Center at San Antonio

You may qualify if…

  • ✓ 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.

You may not qualify if…

  • ✕ 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.

Where it's recruiting

Texas

Fort Cavazos

Source: ClinicalTrials.gov · NCT06551987 · last updated 2026-01-07

Behavioral Insomnia Treatment in Mild Traumatic Brain Injury · TrialPath