Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness-based Stress Reduction class, Brain Health Education class.
- Who it may be relevant to
- Registry conditions: Brain Injury Traumatic Mild, Post-traumatic Stress Disorder. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Mindfulness-Wellness Class Versus Brain Health Education in Veterans With mTBI
Overview
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 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).
Interventions
- Behavioral Mindfulness-based Stress Reduction class
9-week standard Mindfulness-based Stress Reduction class training on mindfulness techniques, medication, and yoga - Behavioral Brain Health Education class
9-week Brain Health education class that involves lectures/discussion about how the brain works and recovers after brain injury
Primary outcome measures
- Mayo-Portland Adaptability Inventory [Time frame: Within 2 weeks post-intervention]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- VA Northern California Health Care System — Martinez
Identifiers
NCT: NCT06150196 · W81XWH-22-1-0820