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
The University of Texas Health Science Center at San Antonio
160 participants
Dec 3, 2024
INTERVENTIONAL
Conditions
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 (BBT-I) in service members with comorbid insomnia and prolonged postconcussive symptoms present for at least 3 months after Mild Traumatic Brain Injury (mTBI).
Eligibility
Inclusion Criteria10
- 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 Criteria5
- 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.
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Interventions
6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Locations(1)
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NCT06551987