Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Brain Injury Traumatic Mild, Post-traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Mindfulness-based Stress Reduction class
* Behavioral: Brain Health Education class


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based Stress Reduction class<br>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<br>* 9-week standard Mindfulness-based Stress Reduction class training on mindfulness techniques, medication, and yoga<br>|
| Active Comparator: Brain Health Education Class<br>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<br>* 9-week Brain Health education class that involves lectures/discussion about how the brain works and recovers after brain injury<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, PTSD, Veteran, Mindfulness-based Stress Reduction, TBI, Anxiety