Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

Recruiting now · Not applicable

Conditions studied: Insomnia, Mild Traumatic Brain Injury

In brief

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).

Key facts

Study ID

NCT06551987

Run by

The University of Texas Health Science Center at San Antonio

People needed

160

Starts

2024-12-03

Expected to finish

2027-09-01

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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