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

NCT01613872 | Completed

• 1 other identifier: 2012-P-000557/1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Feasibility and Safety

  Benchmark measurements of attendance, home practice, adverse events, and focused interviews

  8 weeks

Secondary Outcomes (3)

• Neuropsychological Testing

  8 weeks

• Advanced MRI

  8 weeks

• Questionnaires

  8 weeks

Study Arms (2)

Control

NO INTERVENTION

Wait List Control

Mindfulness Based Stress Reduction

EXPERIMENTAL

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

Other: Mindfulness Based Stress Reduction

Interventions

Mindfulness Based Stress Reduction OTHER

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

Mindfulness Based Stress Reduction

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ross Zafonte, DO

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 7, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 1, 2014

Record last verified: 2014-09

Locations

US (1)