NCT06150196

Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: East Bay Institute for Research and Education · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Brain Injury Traumatic Mild
• Post-traumatic Stress Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-01
• Primary completion: 2026-05-01
• Completion: 2026-09-14
• First posted: 2023-11-29
• Last updated: 2023-11-29

Locations

1 site across 1 country: United States