Brain Injury, Stress, Traumatic Brain Injury
Conditions
Brief summary
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.
Interventions
OTHERMindfulness Based Stress Reduction
An 8 week protocol of stress reduction sessions using gentle yoga and breath meditation
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Safety | 8 weeks | Benchmark measurements of attendance, home practice, adverse events, and focused interviews |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychological Testing | 8 weeks | A neuropsychological battery to be assessed at baseline and post-intervention. |
| Advanced MRI | 8 weeks | Advanced MRI will be used to assess any potential changes (neuroplasticity) |
| Questionnaires | 8 weeks | Questionnaires to assess subjective experiences with the intervention |
Countries
United States
Outcome results
None listed