NCT06551987 · The University of Texas Health Science Center at San Antonio
Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
What this study is about
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).
View original scientific description
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).
Interventions
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.
Primary outcome measures
Insomnia Severity Index (ISI)
Time frame: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. Each item on the ISI is rated on a 5-point Likert scale, ranging from 0 (no problem) to 4 (very severe problem), leading to a total possible score between 0 and 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Neurobehavioral Symptom Inventory (NSI)
Time frame: Baseline, 7 Week Follow-up, 12 Week Follow-up
The NSI is a 22-item self-report measure that assesses postconcussive symptoms and classifies them into vestibular, somatic, cognitive, and affective factors, and indicates symptom severity. Respondents rate the severity of each symptom on a scale from 0 (none) to 4 (very severe). Total scores range between 0-88.
NIH Toolbox v3
Time frame: Baseline, 7 Week Follow-up
The NIH Toolbox Cognition Domain measures several aspects of cognitive functioning, including language, episodic memory, executive function, working memory and processing speed. It is a battery administered and automatically scored on the iPad, assessing cognitive function. Higher scores indicate higher levels of functioning compared nationally. A score around 130 suggest superior ability, around 115 suggest above-average fluid cognitive ability, around 100 is average compared with others nationally, around 85 suggests significantly below-average, 70 or below suggests very low functioning.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Fort Cavazos, Texas
Collaborators
Congressionally Directed Medical Research Programs, Hope Health Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations