NCT06150196NARecruiting

Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

East Bay Institute for Research and Education

Start Date

5/1/2023

Completion Date

9/14/2026

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 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).

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

BEHAVIORAL

Mindfulness-based Stress Reduction class

BEHAVIORAL

Brain Health Education class

Interested in This Trial?

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Conditions

Brain Injury Traumatic MildPost-traumatic Stress Disorder

Locations

VA Northern California Health Care System

Martinez, California 94553

United States