Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

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

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 (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juliana Baldo, PhD; Phone Number: 925-372-4649; Email: Juliana.Baldo@va.gov

Study Locations

• United States
  • California
    • Martinez, California, United States, 94553
      • Recruiting
      • VA Northern California Health Care System
      • Contact: Juliana Baldo, PhD; Phone Number: 925-372-4649; Email: Juliana.Baldo@va.gov
      • Contact: Sandy Lwi, PhD; Phone Number: 925-372-2925; Email: Sandy.Lwi@va.gov

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

• Sponsor: East Bay Institute for Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 14, 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): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: PTSD; Anxiety; Mindfulness; TBI; Veteran; Mindfulness-based Stress Reduction
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Brain Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries; Brain Injuries, Traumatic
• 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