Brain health classes for veterans with brain injuries
Comparison of Mindfulness-Wellness Class Versus Brain Health Education in Veterans With mTBI
This study is testing two different brain health classes to see if they can help veterans with mild brain injuries and PTSD improve their mental health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | East Bay Institute for Research and Education Academic / other |
| Locations | 1 site (Martinez, California) |
| Trial ID | NCT06150196 on ClinicalTrials.gov |
What this trial studies
This study tests the effectiveness of two types of Brain Health & Wellness classes aimed at improving mental health in veterans with a history of mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD). It is a randomized controlled trial involving 120 veterans, where participants are assigned to either a Mindfulness-based Stress Reduction (MBSR) class or a Brain Health education class, which serves as an active control. The study measures changes in psychological and cognitive outcomes before and after the interventions, with follow-up assessments to evaluate the durability of any improvements. Standardized assessments will be used to gauge functional, psychological, and cognitive outcomes.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 18-75 with a chronic history of mild traumatic brain injury and a current diagnosis of PTSD.
Not a fit: Patients with a history of severe brain injuries, major neurological diseases, or severe psychotic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide veterans with effective strategies to improve their mental health and cognitive functioning.
How similar studies have performed: Other studies have shown promising results using mindfulness-based interventions for PTSD and brain injuries, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Martinez, California
- VA Northern California Health Care System — Martinez, California, United States (Recruiting)
Study contacts
- Study coordinator: Juliana Baldo, PhD
- Email: Juliana.Baldo@va.gov
- Phone: 925-372-4649
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.