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

Completed · Not applicable

Conditions studied: Traumatic Brain Injury, Brain Injury, Stress

In brief

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.

Key facts

Study ID

NCT01613872

Run by

Spaulding Rehabilitation Hospital

People needed

8

Starts

2012-05-01

Expected to finish

2013-06-01

Last updated by the study team

2014-10-01

Who can join

Age: 30 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• TBI > 1 year prior to enrollment
• Ages 30-50
• Right handed participants
• History of acute inpatient rehabilitation stay of ≥ 1 night

You may not qualify if…

• 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

Where it is running

• Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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