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

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Mass General Brigham

Status

Completed

Conditions

Traumatic Brain Injury
Brain Injury
Stress

Treatments

Other: Mindfulness Based Stress Reduction

Study type

Interventional

Funder types

Other

Identifiers

NCT01613872
2012-P-000557/1

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

30 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

8 participants in 2 patient groups

Control
No Intervention group
Description:
Wait List Control
Mindfulness Based Stress Reduction
Experimental group
Description:
An 8 week standardized protocol of stress reduction using gentle yoga and meditation
Treatment:
Other: Mindfulness Based Stress Reduction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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