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

Primary Purpose

Traumatic Brain Injury, Brain Injury, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Mindfulness Based Stress Reduction

Arm Description

Wait List Control

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2012
Last Updated
September 30, 2014
Sponsor
Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01613872
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Brain Injury, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Wait List Control
Arm Title
Mindfulness Based Stress Reduction
Arm Type
Experimental
Arm Description
An 8 week standardized protocol of stress reduction using gentle yoga and meditation
Intervention Type
Other
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
An 8 week protocol of stress reduction sessions using gentle yoga and breath meditation
Primary Outcome Measure Information:
Title
Feasibility and Safety
Description
Benchmark measurements of attendance, home practice, adverse events, and focused interviews
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Neuropsychological Testing
Description
A neuropsychological battery to be assessed at baseline and post-intervention.
Time Frame
8 weeks
Title
Advanced MRI
Description
Advanced MRI will be used to assess any potential changes (neuroplasticity)
Time Frame
8 weeks
Title
Questionnaires
Description
Questionnaires to assess subjective experiences with the intervention
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross Zafonte, DO
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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