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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-based Stress Reduction class | Experimental | 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. |
|
| Brain Health Education Class | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based Stress Reduction class | Behavioral | 9-week standard Mindfulness-based Stress Reduction class training on mindfulness techniques, medication, and yoga |
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| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliana Baldo, PhD | Contact | 925-372-4649 | Juliana.Baldo@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Northern California Health Care System | Recruiting | Martinez | California | 94553 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Brain Health Education class | Behavioral | 9-week Brain Health education class that involves lectures/discussion about how the brain works and recovers after brain injury |
|
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |