Clinical trial NCT01613872: The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury
Official title: The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Brain Injury
Stress
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 8
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Feasibility and Safety
timeFrame: 8 weeks
Secondary outcomes:
measure: Neuropsychological Testing
timeFrame: 8 weeks
measure: Advanced MRI
timeFrame: 8 weeks
measure: Questionnaires
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Ross Zafonte, DO
role: PRINCIPAL_INVESTIGATOR
References: