Behavioral treatment for insomnia in military personnel with 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

This study is testing two different types of therapy for insomnia to see which one helps active duty military personnel with mild traumatic brain injury sleep better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (other)
• Locations: 1 site (Fort Cavazos, Texas)
• Trial ID: NCT06551987 on ClinicalTrials.gov

What this trial studies

This clinical trial compares two behavioral therapies for insomnia in active duty military personnel who have experienced mild traumatic brain injury (mTBI) and have ongoing insomnia symptoms. Participants will receive either six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) or four sessions of Brief Behavioral Therapy for Insomnia (BBT-I). The study aims to assess the effectiveness of these treatments on insomnia severity and their potential impact on prolonged postconcussive symptoms. Both in-person and telehealth formats will be available to accommodate participants' schedules.

Who should consider this trial

Good fit: Ideal candidates are active duty U.S. military service members aged 18 and older who have chronic insomnia and have experienced mTBI at least three months prior.

Not a fit: Patients who do not have insomnia or have not experienced mTBI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective behavioral treatment options for insomnia, improving the quality of life for service members with mTBI.

How similar studies have performed: Previous studies have shown that behavioral therapies for insomnia can be effective, suggesting a promising approach for this population.

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.

Where this trial is running

Fort Cavazos, Texas

• Carl R. Darnall Army Medical Center — Fort Cavazos, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Kristi E Pruiksma, PhD — The University of Texas Health Science Center at San Antonio
• Study coordinator: Isabella McElwain, B.S.

Conditions: Insomnia, Mild Traumatic Brain Injury, Cognitive Behavioral Therapy for Insomnia, Brief Behavioral Therapy for Insomnia, Active Duty Military Personnel