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Clinical Trials/NCT01613872
NCT01613872
Completed
Not Applicable

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

Spaulding Rehabilitation Hospital1 site in 1 country8 target enrollmentMay 2012
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ConditionsTraumatic Brain InjuryBrain InjuryStress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Spaulding Rehabilitation Hospital
Enrollment
8
Locations
1
Primary Endpoint
Feasibility and Safety
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
June 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Spaulding Rehabilitation Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ross D. Zafonte, MD

Chair, Physical Medicine and Rehabilitation

Spaulding Rehabilitation Hospital

Eligibility 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

Outcomes

Primary Outcomes

Feasibility and Safety

Time Frame: 8 weeks

Benchmark measurements of attendance, home practice, adverse events, and focused interviews

Secondary Outcomes

  • Questionnaires(8 weeks)
  • Neuropsychological Testing(8 weeks)
  • Advanced MRI(8 weeks)

Study Sites (1)

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