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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Active duty U.S. military service members. - At least 18 years of age. - Ability to provide willing to sign a consent form 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.

BEHAVIORAL

Brief Behavioral Therapy for Insomnia

4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.

Locations (1)

Carl R. Darnall Army Medical Center
Fort Cavazos, Texas, United States