The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury
This study is currently recruiting participants.
Verified June 2012 by Spaulding Rehabilitation Hospital
Sponsor:
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
Ross D. Zafonte, MD, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01613872
First received: May 29, 2012
Last updated: June 5, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Traumatic Brain Injury Brain Injury Stress |
Other: Mindfulness Based Stress Reduction |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury |
Resource links provided by NLM:
Further study details as provided by Spaulding Rehabilitation Hospital:
Primary Outcome Measures:
- Feasibility and Safety [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Benchmark measurements of attendance, home practice, adverse events, and focused interviews
Secondary Outcome Measures:
- Neuropsychological Testing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]A neuropsychological battery to be assessed at baseline and post-intervention.
- Advanced MRI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Advanced MRI will be used to assess any potential changes (neuroplasticity)
- Questionnaires [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Questionnaires to assess subjective experiences with the intervention
| Estimated Enrollment: | 10 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
Wait List Control
|
|
|
Experimental: Mindfulness Based Stress Reduction
An 8 week standardized protocol of stress reduction using gentle yoga and meditation
|
Other: Mindfulness Based Stress Reduction
An 8 week protocol of stress reduction sessions using gentle yoga and breath meditation
|
Eligibility| Ages Eligible for Study: | 30 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613872
Contacts
| Contact: Maulik Purohit, MD | 617-525-6118 | tbimindbody@gmail.com |
Locations
| United States, Massachusetts | |
| Spaulding Rehabilitation Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Maulik Purohit, MD 617-525-6118 tbimindbody@gmail.com | |
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
| Principal Investigator: | Ross Zafonte, DO | Spaulding Rehabilitation Hospital |
More Information
No publications provided
| Responsible Party: | Ross D. Zafonte, MD, Chair, Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital |
| ClinicalTrials.gov Identifier: | NCT01613872 History of Changes |
| Other Study ID Numbers: | 2012-P-000557/1 |
| Study First Received: | May 29, 2012 |
| Last Updated: | June 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013