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Completed

NCT Number: NCT06150196

Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

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.

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Key information

Conditions

Brain Injury Traumatic Mild Anxiety Disorders Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Mental Disorders Nervous System Diseases Post-traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Northern California Health Care System

Martinez, California, 94553, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based Stress Reduction class

Behavioral

9-week standard Mindfulness-based Stress Reduction class training on mindfulness techniques, medication, and yoga

Brain Health Education class

Behavioral

9-week Brain Health education class that involves lectures/discussion about how the brain works and recovers after brain injury

Primary outcomes

  1. Mayo-Portland Adaptability Inventory

    Time frame: Within 2 weeks post-intervention

    Measure of Instrumental Activities of Daily Living with overall score of 0-111, with higher scores indicate greater impairment

Sponsors and collaborators

Lead sponsor

East Bay Institute for Research and Education

Other

Registry information

Official study title

Comparison of Mindfulness-Wellness Class Versus Brain Health Education in Veterans With mTBI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2023
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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