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
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