Skip to main content
OpenTrials
Completed

NCT Number: NCT01613872

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Injury Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Stress Trauma, Nervous System Wounds and Injuries

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Based Stress Reduction

Other

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

Primary outcomes

  1. Feasibility and Safety

    Time frame: 8 weeks

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

Secondary outcomes

  1. Neuropsychological Testing

    Time frame: 8 weeks

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

  2. Advanced MRI

    Time frame: 8 weeks

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

  3. Questionnaires

    Time frame: 8 weeks

    Questionnaires to assess subjective experiences with the intervention

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 7, 2012
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.