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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01613872
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):
Ross D. Zafonte, MD, Spaulding Rehabilitation Hospital

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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Brain Injury Stress Other: Mindfulness Based Stress Reduction

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury
Study Start Date : May 2012
Primary Completion Date : March 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
Other: Mindfulness Based Stress Reduction
An 8 week protocol of stress reduction sessions using gentle yoga and breath meditation

Primary Outcome Measures :
  1. Feasibility and Safety [ Time Frame: 8 weeks ]
    Benchmark measurements of attendance, home practice, adverse events, and focused interviews

Secondary Outcome Measures :
  1. Neuropsychological Testing [ Time Frame: 8 weeks ]
    A neuropsychological battery to be assessed at baseline and post-intervention.

  2. Advanced MRI [ Time Frame: 8 weeks ]
    Advanced MRI will be used to assess any potential changes (neuroplasticity)

  3. Questionnaires [ Time Frame: 8 weeks ]
    Questionnaires to assess subjective experiences with the intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613872

United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Principal Investigator: Ross Zafonte, DO Spaulding Rehabilitation Hospital

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
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System