The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury

Study Overview
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Brief Summary
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This study is studying the effects of Mindfulness Based Stress Reduction (MBSR), a standard protocol of gentle yoga and breath meditation, on patients with Traumatic Brain Injury (TBI). The investigators are testing whether this intervention can help improve the stress response and increase resiliency and mindfulness for patients with TBI, which may lead to improved symptoms and neurocognitive function.

Official Title
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The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury

Conditions
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Traumatic Brain Injury, Brain Injury, Stress

Intervention / Treatment
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* Other: Mindfulness Based Stress Reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: TBI > 1 year prior to enrollment Ages 30-50 Right handed participants History of acute inpatient rehabilitation stay of ≥ 1 night Exclusion Criteria: Non-English speaking (because this is a group intervention, it requires a common language) Dependent with activities of daily living (ADLs) Phone screen (TICS-1) > 30 Rivermead Post-Concussion Questionnaire Score < 21 Actively practicing meditation and/or yoga or have taken a meditation/yoga class in the last 12 months Signs or symptoms of upper motor neuron syndrome Any major major systemic illness or unstable condition which could interfere with protocol compliance, including the diagnosis of major depression Active psychiatric disease that would interfere with participation in the trial Psychotic features, agitation, or behavioral problems within the last 3 months History of alcohol/substance abuse or dependence within the past 2 years Neurosurgical intervention affecting brain parenchyma Reported sequelae from brain lesions or head trauma prior to most recent brain injury Seizure activity or treatment for seizures Use of investigational agents Participating in other clinical studies involving neuropsychological measures collected more than one time per year Any involvement in legal matters (workers' compensation, litigation, et al), past, present, or anticipated in the future, related to the TBI Unable to undergo MRI for any reason such as claustrophobia, presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Wait List Control | |
| Experimental: Mindfulness Based Stress Reduction<br>An 8 week standardized protocol of stress reduction using gentle yoga and meditation | Other: Mindfulness Based Stress Reduction<br>* An 8 week protocol of stress reduction sessions using gentle yoga and breath meditation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and Safety | Benchmark measurements of attendance, home practice, adverse events, and focused interviews | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological Testing | A neuropsychological battery to be assessed at baseline and post-intervention. | 8 weeks | 
| Advanced MRI | Advanced MRI will be used to assess any potential changes (neuroplasticity) | 8 weeks | 
| Questionnaires | Questionnaires to assess subjective experiences with the intervention | 8 weeks |