Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

September 10, 2026 updated by: East Bay Institute for Research and Education

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Martinez, California, United States, 94553
        • VA Northern California Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-based Stress Reduction class
Mindfulness-based Stress Reduction (MBSR) is a 9-week class that meets 2.5 hours/week and involves training in mindfulness (being present in the moment), meditation, and yoga. The MBSR course is taught by a certified MBSR instructor.
Behavioral: Mindfulness-based Stress Reduction class
9-week standard Mindfulness-based Stress Reduction class training on mindfulness techniques, medication, and yoga
Active Comparator: Brain Health Education Class
the Brain Health Education Class is a 9-week class that meets 2.5 hours/week and involves lectures/discussion about how the brain works, how the brain ages, neuroplasticity, and other topics on the brain.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 2 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Bay Institute for Research and Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

June 30, 2026

Study Completion (Actual)

June 30, 2026

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81XWH-22-1-0820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe