Traumatic Brain InjuryNCT01613872
The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury
A study testing Mindfulness Based Stress Reduction in people with Traumatic Brain Injury and Brain Injury, run by Spaulding Rehabilitation Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Brain Injury, Stress
- What is being tested?
- Mindfulness Based Stress Reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- TBI > 1 year prior to enrollment
- Ages 30-50
- Right handed participants
- History of acute inpatient rehabilitation stay of ≥ 1 night
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
About this study
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
- Being tested
- Mindfulness Based Stress Reduction
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress ReductionOther
An 8 week protocol of stress reduction sessions using gentle yoga and breath meditation
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Wait List Control |
| Mindfulness Based Stress Reduction | Experimental | An 8 week standardized protocol of stress reduction using gentle yoga and meditation Receives: Other: Mindfulness Based Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Safety
Benchmark measurements of attendance, home practice, adverse events, and focused interviews
Measured: 8 weeks
Secondary outcomes (3)
Neuropsychological Testing
A neuropsychological battery to be assessed at baseline and post-intervention.
Measured: 8 weeks
Advanced MRI
Advanced MRI will be used to assess any potential changes (neuroplasticity)
Measured: 8 weeks
Questionnaires
Questionnaires to assess subjective experiences with the intervention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ross D. Zafonte, MD, Spaulding Rehabilitation Hospital
- Investigators
- Ross Zafonte, DO, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613872
- Sponsor's protocol ID
- 2012-P-000557/1
- Status last verified
- Sep 2014
- First submitted
- 29 May 2012
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01613872
- Acronym / sponsor ID
- 2012-P-000557/1
- Conditions
- Traumatic Brain Injury, Brain Injury, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Wait List Control |
| Mindfulness Based Stress Reduction | Experimental | Other: Mindfulness Based Stress ReductionAn 8 week standardized protocol of stress reduction using gentle yoga and meditation |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- TBI > 1 year prior to enrollment
- Ages 30-50
- Right handed participants
- History of acute inpatient rehabilitation stay of ≥ 1 night
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress ReductionAn 8 week protocol of stress reduction sessions using gentle yoga and breath meditation | Other | Mindfulness Based Stress Reduction |
Primary outcome
Feasibility and Safety
Time frame: 8 weeks
Benchmark measurements of attendance, home practice, adverse events, and focused interviews
3 secondary outcomes
Neuropsychological Testing
Time frame: 8 weeks
Advanced MRI
Time frame: 8 weeks
Questionnaires
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross Zafonte, DO principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction in people with Traumatic Brain Injury and Brain Injury, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Safety (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.