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Sleep therapy showdown: can brief counseling help troops with brain injury?

NCT ID NCT06551987

Symptom relief Sponsor: The University of Texas Health Science Center at San Antonio Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of talk therapy for insomnia in 160 active-duty military members who have had a mild traumatic brain injury and still have symptoms like trouble sleeping, thinking, or mood issues. One therapy is longer (6 sessions) and the other is shorter (4 sessions). The goal is to see which one better improves sleep and reduces brain injury-related symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Brain Concussion insomnia traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia Mild traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Carl R. Darnall Army Medical Center

    RECRUITING

    Fort Cavazos, Texas, 76544, United States

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