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Can mindfulness or CBT fix insomnia after a concussion?

NCT ID NCT05663034

Symptom relief Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Updated 2 times

Summary

This study tests two behavioral treatments—cognitive behavioral therapy (CBT) and mindfulness—to help people with traumatic brain injury (TBI) sleep better and feel less stressed. 360 veterans and service members with mild to moderate TBI, insomnia, and PTSD symptoms will receive 6 weekly sessions via video. Researchers will track sleep quality, mood, and memory for up to 12 weeks after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI)
What this could lead to
If successful, this could show that either therapy is an effective, drug-free way to improve sleep and mood in people with TBI and PTSD.
What could go wrong
This is a mid-sized trial comparing two existing therapies, not a new breakthrough. Results may not apply to everyone with TBI, and benefits may be modest.

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 360 people

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

Started

May 2024

Expected to finish

Jun 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 years and older

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: 1. Current or former member of the uniform services 2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI; 3. Time duration since traumatic brain injury (TBI) injury \>90 days 4. Insomnia symptom duration \>90 days 5. Endorse insomnia symptoms (Insomnia Severity Index \[ISI\] score \> 10) 6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \> -2) 7. \>18 years of age 8. Access to and ability and to use computer. Exclusion Criteria: 1. History of neurological diseases other than TBI and not attributable to TBI 2. Sleep apnea \[apnea hypopnea index (AHI) \>15; individuals with mild apnea (AHI \> 5 and \<15) will be informed, but allowed to participate\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea/hypopnea cutoff while using CPAP, are adherent to using the device (\> 4 hours/night 21/30 consecutive days) and agree to continue using the device during study participation. 3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.

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Conditions

The condition(s) this trial relates to.

Brain Concussion Brain Injuries, Traumatic brain injury Craniocerebral Trauma Depression depressive disorder head injury insomnia Memory Disorders post-traumatic stress disorder sleep disorder traumatic brain injury

As listed by the trial registrant

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

Brain injury traumatic mild Cognitive behavioral therapy Concussion, brain Depression Head injury Insomnia Memory impairment Post-traumatic stress Sleep 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

    5 sites. 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Intrepid Spirit Center - Eglin Air Force Base

    RECRUITING

    Eglin Air Force Base, Florida, 32542, United States

  • Madigan Army Medical Center

    RECRUITING

    Fort Lewis, Washington, 98431, United States

  • Naval School Explosive Ordance Disposal - Eglin Air Force Base

    RECRUITING

    Eglin Air Force Base, Florida, 32542, United States

  • Walter Reed National Medical Military Center

    RECRUITING

    Bethesda, Maryland, 20814, United States

  • Womack Army Medical Center

    RECRUITING

    Fort Bragg, North Carolina, 28310, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.