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Behavioral Intervention
Brain Health & Wellness Classes for Veterans with Concussion-Related Issues
N/A
Recruiting
Research Sponsored by East Bay Institute for Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current diagnosis of PTSD
18-75 years old
Must not have
No history of moderate or severe TBI
No history of other neurologic disease (e.g., tumor, stroke, dementia, Parkinson's)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2 weeks post-intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if classes can help Veterans with concussion-related mental health issues.
Who is the study for?
This trial is for veterans aged 18-75 with a history of mild traumatic brain injuries (mTBIs) over 6 months old, currently diagnosed with PTSD, and experiencing cognitive symptoms. It's not open to those with other neurological diseases, major brain surgeries, moderate/severe TBI, recent substance abuse, severe psychotic disorders or current severe suicidal risks.
What is being tested?
The study examines the effectiveness of two classes aimed at improving mental health in veterans who have suffered concussions: Brain Health Education and Mindfulness-based Stress Reduction. Participants will attend these wellness classes designed specifically for their needs.
What are the potential side effects?
Since the interventions are non-medical educational and mindfulness classes rather than drugs or medical procedures, significant side effects are not expected. However, discussing emotional topics during sessions could potentially cause discomfort or emotional distress.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PTSD.
Select...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never had a moderate or severe traumatic brain injury.
Select...
I have no history of serious brain or nerve conditions.
Select...
I have never had major brain surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 2 weeks post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 weeks post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mayo-Portland Adaptability Inventory
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-based Stress Reduction classExperimental Treatment1 Intervention
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.
Group II: Brain Health Education ClassActive Control1 Intervention
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.
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Who is running the clinical trial?
East Bay Institute for Research and EducationLead Sponsor
8 Previous Clinical Trials
494 Total Patients Enrolled
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