- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01613872
The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury
September 30, 2014 updated by: Ross D. Zafonte, MD, Spaulding Rehabilitation Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Spaulding Rehabilitation Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Wait List Control
|
|
Experimental: Mindfulness Based Stress Reduction
An 8 week standardized protocol of stress reduction using gentle yoga and meditation
|
An 8 week protocol of stress reduction sessions using gentle yoga and breath meditation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and Safety
Time Frame: 8 weeks
|
Benchmark measurements of attendance, home practice, adverse events, and focused interviews
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychological Testing
Time Frame: 8 weeks
|
A neuropsychological battery to be assessed at baseline and post-intervention.
|
8 weeks
|
Advanced MRI
Time Frame: 8 weeks
|
Advanced MRI will be used to assess any potential changes (neuroplasticity)
|
8 weeks
|
Questionnaires
Time Frame: 8 weeks
|
Questionnaires to assess subjective experiences with the intervention
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ross Zafonte, DO, Spaulding Rehabilitation Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
May 29, 2012
First Submitted That Met QC Criteria
June 5, 2012
First Posted (Estimate)
June 7, 2012
Study Record Updates
Last Update Posted (Estimate)
October 1, 2014
Last Update Submitted That Met QC Criteria
September 30, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-P-000557/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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