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CompletedNCT01613872Updated Oct 1, 2014

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

An interventional study of Mindfulness Based Stress Reduction in Traumatic Brain Injury, Brain Injury and Stress, sponsored by Spaulding Rehabilitation Hospital. Completed at 1 site in United States. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Traumatic Brain Injury
  • Brain Injury
  • Stress
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's enrollment of 8 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Spaulding Rehabilitation Hospital is the lead sponsor of 114 studies on the registry; 26 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • No intervention
    Control

    Wait List Control

  • Experimental
    Mindfulness Based Stress Reduction

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

    Other: Mindfulness Based Stress Reduction

Interventions

  • OtherMindfulness Based Stress Reduction

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

06

What researchers measure

Primary outcomes

  1. Feasibility and Safety

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

    Time frame: 8 weeks

Secondary outcomes

  1. Neuropsychological Testing

    A neuropsychological battery to be assessed at baseline and post-intervention.

    Time frame: 8 weeks

  2. Advanced MRI

    Advanced MRI will be used to assess any potential changes (neuroplasticity)

    Time frame: 8 weeks

  3. Questionnaires

    Questionnaires to assess subjective experiences with the intervention

    Time frame: 8 weeks

07

Study locations

1 site
  • Spaulding Rehabilitation Hospital
    Boston, Massachusetts 02114, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01613872
Lead sponsor
Spaulding Rehabilitation Hospital
Responsible party
Ross D. Zafonte, MD (Chair, Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital) — Principal investigator
First posted
Jun 7, 2012
Start date
May 2012
Primary completion
Mar 2013
Completion
Jun 2013
Last update
Oct 1, 2014

Study contacts

Ross Zafonte, DO
principal investigator · Spaulding Rehabilitation Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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