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

NCT ID: NCT01613872

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-06-30

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.

Conditions

Traumatic Brain Injury; Brain Injury; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Wait List Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mindfulness Based Stress Reduction

An 8 week standardized protocol of stress reduction using gentle yoga and meditation

Group Type: EXPERIMENTAL

Mindfulness Based Stress Reduction

Intervention Type: OTHER

An 8 week protocol of stress reduction sessions using gentle yoga and breath meditation

Interventions

Mindfulness Based Stress Reduction

An 8 week protocol of stress reduction sessions using gentle yoga and breath meditation

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ross D. Zafonte, MD

Chair, Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ross Zafonte, DO

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2012-P-000557/1

Identifier Type: -

Identifier Source: org_study_id