Actively Recruiting
Comparison of Mindfulness-Wellness Class Versus Brain Health Education in Veterans With mTBI
Led by East Bay Institute for Research and Education · Updated on 2023-11-29
80
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two types of Brain Health and Wellness classes for Veterans who have a history of mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD). This pragmatic, randomized controlled trial aims to compare Mindfulness-based Stress Reduction (MBSR) with Brain Health education to see how each impacts mental health, cognitive function, and daily adaptability. The study is sponsored by the East Bay Institute for Research and Education and includes a 6-month follow-up to observe lasting changes. Participants are randomly assigned to one of two 9-week classes. The MBSR class meets once a week for 2.5 hours and involves mindfulness training, meditation, and yoga, led by a certified instructor. The Brain Health Education class also meets once weekly for 2.5 hours and focuses on lectures and discussions about brain function, aging, neuroplasticity, and recovery after brain injury. Both groups receive active interventions designed to support brain health and wellness. Throughout the study, participants undergo standardized psychological and cognitive tests before and after their assigned class to measure changes. Key assessments include the Mayo-Portland Adaptability Inventory IV, PTSD Checklist, and cognitive control tests. Researchers monitor these outcomes within two weeks after completing the intervention and again at a 6-month follow-up. The total duration of participation includes the 9-week classes plus follow-up assessments to evaluate the interventions' longer-term effects.
CONDITIONS
Brief Title
Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Chronic history of one or more mild traumatic brain injuries lasting more than 6 months
- Current diagnosis of post-traumatic stress disorder (PTSD)
- At least one self-reported cognitive symptom
You will not qualify if you...
- History of other neurological diseases such as tumor, stroke, dementia, or Parkinson's disease
- History of major brain surgery
- History of moderate or severe traumatic brain injury
- Active alcohol or drug dependence or abuse within the previous 30 days
- History of severe psychotic disorders such as schizophrenia
- Current suicidal ideation or risk
- Clinically severe medical illness requiring treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 weeks
Participants attend either a 9-week Mindfulness-based Stress Reduction class or a Brain Health Education class, each meeting 2.5 hours per week.
Weekly class sessions for 9 weeks
Duration - 6 months
Participants complete assessments up to 6 months after the class to evaluate lasting changes in brain health and wellness.
1 follow-up visit approximately 6 months after treatment
Trial Site Locations
Total: 1 location
1
VA Northern California Health Care System
Martinez, California, United States, 94553
Actively Recruiting
Research Team
J
Juliana Baldo, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here