Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury
Purpose
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.
Conditions
- Brain Injury Traumatic Mild
- Post-traumatic Stress Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 18-75 years old - chronic history (>6 months) of one or more mTBIs - current diagnosis of PTSD - at least one self-reported cognitive symptom
Exclusion Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Mindfulness-based Stress Reduction class |
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. |
|
|
Active Comparator Brain Health Education Class |
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. |
|
Recruiting Locations
Martinez, California 94553
More Details
- Status
- Recruiting
- Sponsor
- East Bay Institute for Research and Education
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).