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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613872
• Other study ID #: 2012-P-000557/1
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: September 30, 2014
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2014
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Stress
• Traumatic Brain Injury

Intervention

Other:
• Mindfulness Based Stress Reduction
An 8 week protocol of stress reduction sessions using gentle yoga and breath meditation

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and Safety	Benchmark measurements of attendance, home practice, adverse events, and focused interviews	8 weeks	Yes
Secondary	Neuropsychological Testing	A neuropsychological battery to be assessed at baseline and post-intervention.	8 weeks	No
Secondary	Advanced MRI	Advanced MRI will be used to assess any potential changes (neuroplasticity)	8 weeks	No
Secondary	Questionnaires	Questionnaires to assess subjective experiences with the intervention	8 weeks	No