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Behavioral Insomnia Treatment for Mild Traumatic Brain Injury

This study is looking for active duty U.S. military service members, aged 18 to 45, who have experienced a mild traumatic brain injury (mTBI) at least three months ago and are also struggling with insomnia. The goal is to find the best way to treat insomnia in service members who also have lasting symptoms after an mTBI. You would receive either Cognitive Behavioral Therapy for Insomnia (CBT-I), which is 6 weekly sessions, or Brief Behavioral Therapy for Insomnia (BBT-I), which is 4 weekly sessions. Both therapies are delivered individually, either in person or through telehealth. Researchers will measure your insomnia severity, neurobehavioral symptoms, and cognitive abilities to see how well the treatments work. The study's current recruitment status is unclear.

Study design
This is a randomized controlled trial comparing two behavioral therapies for insomnia in 160 participants.
What's involved
You would attend either 4 or 6 weekly therapy sessions, lasting 30 or 50 minutes each. You would also complete assessments at the start, during treatment, and at 7 and 12 weeks after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06551987

Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

Recruiting
NAAges 18–45InterventionalTreatment
The University of Texas Health Science Center at San Antonio
~160 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:Cognitive Behavioral Therapy for InsomniaBrief Behavioral Therapy for Insomnia

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insomnia Severity Index (ISI)
Measured over Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up
+2 more outcomes measured

Conditions

Insomnia
Mild Traumatic Brain Injury

Explore related trials

ConcussionInsomnia

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Kristi E Pruiksma, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

Who to contact

Isabella McElwain, B.S.
[email protected]
254-226-6987
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Insomnia Severity Index (ISI)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)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 v3Baseline, 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.