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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ross D. Zafonte, MD, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01613872
First received: May 29, 2012
Last updated: May 29, 2013
Last verified: May 2013
  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


Enrollment: 8
Study Start Date: May 2012
Estimated Study Completion Date: June 2013
Primary Completion Date: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613872

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
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: May 29, 2013
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 September 18, 2014