Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

Post-traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150196
• Other study ID #: W81XWH-22-1-0820
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 14, 2026

Study information

• Verified date: November 2023
• Source: East Bay Institute for Research and Education
• Contact: Juliana Baldo, PhD
• Phone: 925-372-4649
• Email: Juliana.Baldo[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 14, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury Traumatic Mild
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Wounds and Injuries

Intervention

Behavioral:
• Mindfulness-based Stress Reduction class
9-week standard Mindfulness-based Stress Reduction class training on mindfulness techniques, medication, and yoga
• Brain Health Education class
9-week Brain Health education class that involves lectures/discussion about how the brain works and recovers after brain injury

Locations

Country	Name	City	State
United States	VA Northern California Health Care System	Martinez	California

Sponsors (1)

Lead Sponsor	Collaborator
East Bay Institute for Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mayo-Portland Adaptability Inventory	Measure of Instrumental Activities of Daily Living with overall score of 0-111, with higher scores indicate greater impairment	Within 2 weeks post-intervention