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

Not Applicable

Completed

• Conditions: Traumatic Brain Injury; Brain Injury; Stress
• Interventions: Other: Mindfulness Based Stress Reduction

• Registration Number: NCT01613872
• Lead Sponsor: Spaulding Rehabilitation Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-07
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-30
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Based Stress Reduction	Mindfulness Based Stress Reduction	An 8 week standardized protocol of stress reduction using gentle yoga and meditation

Primary Outcome Measures

Name	Time	Method
Feasibility and Safety	8 weeks	Benchmark measurements of attendance, home practice, adverse events, and focused interviews

Secondary Outcome Measures

Name	Time	Method
Questionnaires	8 weeks	Questionnaires to assess subjective experiences with the intervention
Neuropsychological Testing	8 weeks	A neuropsychological battery to be assessed at baseline and post-intervention.
Advanced MRI	8 weeks	Advanced MRI will be used to assess any potential changes (neuroplasticity)

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States