Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

Sponsor

East Bay Institute for Research and Education (Other)

Overall Status

Recruiting

CT.gov ID

NCT06150196

Collaborator

(none)

Enrollment

Location

Arms

40.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Injury Traumatic Mild Post-traumatic Stress Disorder	Behavioral: Mindfulness-based Stress Reduction class Behavioral: Brain Health Education class	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

Sep 14, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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