Behavioral treatment for insomnia in military personnel with mild traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: Isabella.l.mcelwain.ctr@health.mil
• Phone: 254-226-6987

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.