Brain Injury Traumatic MildNCT06150196
Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury
A study testing Mindfulness-based Stress Reduction class and Brain Health Education class in people with Brain Injury Traumatic Mild and Post-traumatic Stress Disorder, run by East Bay Institute for Research and Education at 1 site in United States.
Trial summary
This study is testing the usefulness of two types of Brain Health \& Wellness classes for Veterans with a history of concussion to improve mental health. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Injury Traumatic Mild, Post-traumatic Stress Disorder
- What is being tested?
- Mindfulness-based Stress Reduction class and Brain Health Education class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old
- chronic history (>6 months) of one or more mTBIs
- current diagnosis of PTSD
- at least one self-reported cognitive symptom
Who cannot join
- no history of other neurologic disease (e.g., tumor, stroke, dementia, Parkinson's)
- no history of major brain surgery
- no history of moderate or severe TBI
- no active alcohol or drug dependence or abuse within previous 30 days
- no history of severe psychotic disorder (e.g., schizophrenia)
- no current suicidal ideation/risk
- no clinically severe medical illness requiring treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Northern California Health Care System
Martinez, California, 94553
About this study
Official title: Comparison of Mindfulness-Wellness Class Versus Brain Health Education in Veterans With mTBI
This study is testing the usefulness of two types of Brain Health \& Wellness classes for Veterans with a history of concussion to improve mental health.
Read the detailed description
This is a pragmatic, randomized controlled trial of Mindfulness-based Stress Reduction (MBSR) in 120 Veterans with comorbid PTSD and chronic mTBI. Half of the participants are randomly assigned to MBSR and the other half, to a Brain Health education class, which serves as an active control group. A battery of standardized psychological and cognitive measures are administered prior to and following the class interventions to assess change in response to the intervention, with an additional 6-month follow-up assessment to test for lasting changes. The primary outcome measures include the Mayo-Portland Adaptability Inventory IV (functional outcome), PTSD Checklist (psychological outcome), and cognitive control test (cognitive outcome).
- Being tested
- Mindfulness-based Stress Reduction class, Brain Health Education class
- Keywords
- Mindfulness, Mindfulness-based Stress Reduction, TBI, Anxiety, PTSD, Veteran
- Medical subject headings
- Brain Concussion, Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Stress Reduction classBehavioural
9-week standard Mindfulness-based Stress Reduction class training on mindfulness techniques, medication, and yoga
Brain Health Education classBehavioural
9-week Brain Health education class that involves lectures/discussion about how the brain works and recovers after brain injury
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Stress Reduction class | Experimental | Mindfulness-based Stress Reduction (MBSR) is a 9-week class that meets 2.5 hours/week and involves training in mindfulness (being present in the moment), meditation, and yoga. The MBSR course is taught by a certified MBSR instructor. Receives: Behavioral: Mindfulness-based Stress Reduction class |
| Brain Health Education Class | Active comparator | the Brain Health Education Class is a 9-week class that meets 2.5 hours/week and involves lectures/discussion about how the brain works, how the brain ages, neuroplasticity, and other topics on the brain. Receives: Behavioral: Brain Health Education class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo-Portland Adaptability Inventory
Measure of Instrumental Activities of Daily Living with overall score of 0-111, with higher scores indicate greater impairment
Measured: Within 2 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 May 2023
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury Traumatic MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Bay Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150196
- Sponsor's protocol ID
- W81XWH-22-1-0820
- Status last verified
- Sep 2025
- First submitted
- 12 Oct 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mindfulness-Wellness Class Versus Brain Health Education in Veterans With mTBI
- ClinicalTrials.gov ID
- NCT06150196
- Acronym / sponsor ID
- W81XWH-22-1-0820
- Keywords
- Mindfulness, Mindfulness-based Stress Reduction, TBI, Anxiety, PTSD, Veteran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- East Bay Institute for Research and EducationUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing the usefulness of two types of Brain Health \& Wellness classes for Veterans with a history of concussion to improve mental health.
Detailed description
This is a pragmatic, randomized controlled trial of Mindfulness-based Stress Reduction (MBSR) in 120 Veterans with comorbid PTSD and chronic mTBI. Half of the participants are randomly assigned to MBSR and the other half, to a Brain Health education class, which serves as an active control group. A battery of standardized psychological and cognitive measures are administered prior to and following the class interventions to assess change in response to the intervention, with an additional 6-month follow-up assessment to test for lasting changes. The primary outcome measures include the Mayo-Portland Adaptability Inventory IV (functional outcome), PTSD Checklist (psychological outcome), and cognitive control test (cognitive outcome).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Stress Reduction class | Experimental | Behavioral: Mindfulness-based Stress Reduction classMindfulness-based Stress Reduction (MBSR) is a 9-week class that meets 2.5 hours/week and involves training in mindfulness (being present in the moment), meditation, and yoga. The MBSR course is taught by a certified MBSR instructor. |
| Brain Health Education Class | Active comparator | Behavioral: Brain Health Education classthe Brain Health Education Class is a 9-week class that meets 2.5 hours/week and involves lectures/discussion about how the brain works, how the brain ages, neuroplasticity, and other topics on the brain. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years old
- chronic history (>6 months) of one or more mTBIs
- current diagnosis of PTSD
- at least one self-reported cognitive symptom
Key exclusion criteria (7 listed)
- no history of other neurologic disease (e.g., tumor, stroke, dementia, Parkinson's)
- no history of major brain surgery
- no history of moderate or severe TBI
- no active alcohol or drug dependence or abuse within previous 30 days
- no history of severe psychotic disorder (e.g., schizophrenia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Stress Reduction class9-week standard Mindfulness-based Stress Reduction class training on mindfulness techniques, medication, and yoga | Behavioural | Mindfulness-based Stress Reduction class |
| Brain Health Education class9-week Brain Health education class that involves lectures/discussion about how the brain works and recovers after brain injury | Behavioural | Brain Health Education Class |
Primary outcome
Mayo-Portland Adaptability Inventory
Time frame: Within 2 weeks post-intervention
Measure of Instrumental Activities of Daily Living with overall score of 0-111, with higher scores indicate greater impairment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Brain Injury Traumatic Mild
Enrolling by invitationPhase 1
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Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
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Pilot TMS in Mild TBI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Stress Reduction class and Brain Health Education class in people with Brain Injury Traumatic Mild and Post-traumatic Stress Disorder, run by East Bay Institute for Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mayo-Portland Adaptability Inventory (time frame: Within 2 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.