Status:
RECRUITING
Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury
Lead Sponsor:
East Bay Institute for Research and Education
Conditions:
Brain Injury Traumatic Mild
Post-traumatic Stress Disorder
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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.
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 MBS...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 14 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06150196
Start Date
May 1 2023
End Date
September 14 2026
Last Update
November 29 2023
Active Locations (1)
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1
VA Northern California Health Care System
Martinez, California, United States, 94553