Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

Not Applicable

Recruiting

• Conditions: Brain Injury Traumatic Mild; Post-traumatic Stress Disorder
• Interventions: Behavioral: Brain Health Education class; Behavioral: Mindfulness-based Stress Reduction class

• Registration Number: NCT06150196
• Lead Sponsor: East Bay Institute for Research and Education

Brief 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).

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-10-12
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-20
• Study First Posted: 2023-11-29
• Last Update Posted: 2023-11-29
• Primary Completion: 2026-05-01
• Study Completion: 2026-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brain Health Education Class	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.
Mindfulness-based Stress Reduction class	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.

Primary Outcome Measures

Name	Time	Method
Mayo-Portland Adaptability Inventory	Within 2 weeks post-intervention	Measure of Instrumental Activities of Daily Living with overall score of 0-111, with higher scores indicate greater impairment

Trial Locations

Locations (1)

VA Northern California Health Care System; 🇺🇸 Martinez, California, United States