Healthy IndividualsNCT01320969
Could Meditation Modulate the Neurobiology of Learning Not to Fear?
A study testing Mindfulness-Based Stress Reduction course in people with Healthy Individuals and Highly Stressed, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
It is well-established that the practice of mindfulness meditation leads to improvements in mental health and well-being and the cultivation of positive emotions. However, the neural mechanisms of these improvements are largely unknown. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals, Highly Stressed
- What is being tested?
- Mindfulness-Based Stress Reduction course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to May 2012
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years of age Proficient in English Right-handed Free of medication that affect cerebral metabolism Able to give informed consent High stress level (defined as a score of >= 3 on the 4-item Perceived Stress Scale).
Who cannot join
- More than 10 meditation sessions of any tradition in their lifetime, or more than 5 sessions within the last year.
- More than 10 yoga sessions of any tradition in their lifetime, or more than 5 sessions within the last year.
- History of neurologic or psychiatric disease, substance abuse or dependence that is current or within the last year.
- Major/chronic medical conditions History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae History of seizures History of stroke Prior neurosurgical procedure Metal in the body, metal injury to the eyes Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt Pregnancy; breastfeeding or nursing Claustrophobia Weight > 350 lbs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
Official title: Effects of Mindfulness Practice on the Neural Circuitry of Conditioned Fear Extinction in Healthy Participants
It is well-established that the practice of mindfulness meditation leads to improvements in mental health and well-being and the cultivation of positive emotions. However, the neural mechanisms of these improvements are largely unknown. A few recent studies suggest that mindfulness meditation impacts the structure and function of the ventromedial prefrontal cortex, the hippocampus, and the amygdala. Interestingly, recent studies have shown that these regions are part of a brain circuit that is critical for the extinction of conditioned fear responses, and for the retention of fear extinction memory. Building on the overlap of these regions and on conceptual considerations, the project investigates whether mindfulness meditation could influence one's capacity to retain the memory of fear extinction. Meditation-naïve participants will be randomized to either a mindfulness-meditation based training or an active control training that controls for all mindfulness-unspecific components. Participants will undergo a fear conditioning, extinction and extinction recall protocol in an MRI scanner before and after the trainings. We hypothesize that participants who have practiced mindfulness meditation will show greater improvements in fear extinction memory after the course, and that these improvements will be correlated with anatomical and functional changes in the brain regions of interest. Improvements in fear extinction memory will also be related to improvements in self-reported psychological well-being. Merging the fields of an ancient spiritual tradition and a fundamental learning mechanism, the project investigates the underlying neural mechanisms of a practice for the enhancement of mental health and well-being.
- Conditions
- Healthy Individuals, Highly Stressed
- Being tested
- Mindfulness-Based Stress Reduction course
- Keywords
- mindfulness, fear conditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction courseBehavioural
an eight-week mindfulness-based stress reduction course
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction course | Experimental | an eight week mindfulness-based stress reduction course Receives: Behavioral: Mindfulness-Based Stress Reduction course |
| Waitlist group | No intervention | waitlist group |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in MRI data
We will measure the change in functional MRI during fear conditioning, extinction, and extinction retention memory pre to post intervention. Furthermore, we will measure changes in structural MRI data, DTI data and resting state fMRI data.
Measured: pre and post intervention or wait period; first set of MRIs within 3 weeks before the course, second set of MRIs within 3 weeks after course; MRIs will take 1.5 hours each and will occur on 2 consecutive days
Secondary outcomes (1)
change in well-being
questionnaire data will also be collected pre and post the intervention / wait period; change in the scores will be assessed
Measured: pre and post intervention or waitlist period; collected when the MRIs take place; will take about one hour each
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, John Templeton Foundation, Mind and Life Institute, Hadley, Massachusetts
- Responsible party
- Principal investigator, Britta Holzel, Massachusetts General Hospital
- Investigators
- Britta K Holzel, PhD, Principal investigator, Massachusetts General HospitalMohammed R Milad, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320969
- Sponsor's protocol ID
- 2010-P-002025
- Status last verified
- May 2012
- First submitted
- 17 Mar 2011
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Holzel BK, Brunsch V, Gard T, Greve DN, Koch K, Sorg C, Lazar SW, Milad MR. Mindfulness-Based Stress Reduction, Fear Conditioning, and The Uncinate Fasciculus: A Pilot Study. Front Behav Neurosci. 2016 Jun 15;10:124. doi: 10.3389/fnbeh.2016.00124. eCollection 2016.
PubMed 27378875
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Practice on the Neural Circuitry of Conditioned Fear Extinction in Healthy Participants
- ClinicalTrials.gov ID
- NCT01320969
- Acronym / sponsor ID
- 2010-P-002025
- Conditions
- Healthy Individuals, Highly Stressed
- Keywords
- mindfulness, fear conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Pennsylvania, John Templeton Foundation, Mind and Life Institute, Hadley, Massachusetts
- Study start
- Dec 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 23 Mar 2011 (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.
It is well-established that the practice of mindfulness meditation leads to improvements in mental health and well-being and the cultivation of positive emotions. However, the neural mechanisms of these improvements are largely unknown. A few recent studies suggest that mindfulness meditation impacts the structure and function of the ventromedial prefrontal cortex, the hippocampus, and the amygdala. Interestingly, recent studies have shown that these regions are part of a brain circuit that is critical for the extinction of conditioned fear responses, and for the retention of fear extinction memory. Building on the overlap of these regions and on conceptual considerations, the project investigates whether mindfulness meditation could influence one's capacity to retain the memory of fear extinction. Meditation-naïve participants will be randomized to either a mindfulness-meditation based training or an active control training that controls for all mindfulness-unspecific components. Participants will undergo a fear conditioning, extinction and extinction recall protocol in an MRI scanner before and after the trainings. We hypothesize that participants who have practiced mindfulness meditation will show greater improvements in fear extinction memory after the course, and that these improvements will be correlated with anatomical and functional changes in the brain regions of interest. Improvements in fear extinction memory will also be related to improvements in self-reported psychological well-being. Merging the fields of an ancient spiritual tradition and a fundamental learning mechanism, the project investigates the underlying neural mechanisms of a practice for the enhancement of mental health and well-being.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction course | Experimental | Behavioral: Mindfulness-Based Stress Reduction coursean eight week mindfulness-based stress reduction course |
| Waitlist group | No intervention | –waitlist group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-65 years of age Proficient in English Right-handed Free of medication that affect cerebral metabolism Able to give informed consent High stress level (defined as a score of >= 3 on the 4-item Perceived Stress Scale).
Key exclusion criteria (4 listed)
- More than 10 meditation sessions of any tradition in their lifetime, or more than 5 sessions within the last year.
- More than 10 yoga sessions of any tradition in their lifetime, or more than 5 sessions within the last year.
- History of neurologic or psychiatric disease, substance abuse or dependence that is current or within the last year.
- Major/chronic medical conditions History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae History of seizures History of stroke Prior neurosurgical procedure Metal in the body, metal injury to the eyes Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt Pregnancy; breastfeeding or nursing Claustrophobia Weight > 350 lbs.
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 Reduction coursean eight-week mindfulness-based stress reduction course | Behavioural | Mindfulness-Based Stress Reduction course |
Primary outcome
change in MRI data
Time frame: pre and post intervention or wait period; first set of MRIs within 3 weeks before the course, second set of MRIs within 3 weeks after course; MRIs will take 1.5 hours each and will occur on 2 consecutive days
We will measure the change in functional MRI during fear conditioning, extinction, and extinction retention memory pre to post intervention. Furthermore, we will measure changes in structural MRI data, DTI data and resting state fMRI data.
1 secondary outcome
change in well-being
Time frame: pre and post intervention or waitlist period; collected when the MRIs take place; will take about one hour each
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 7 May 2012.
- Derived from this study: PubMed 27378875Holzel BK, Brunsch V, Gard T, Greve DN, Koch K, Sorg C, Lazar SW, Milad MR. Mindfulness-Based Stress Reduction, Fear Conditioning, and The Uncinate Fasciculus: A Pilot Study. Front Behav Neurosci. 2016 Jun 15;10:124. doi: 10.3389/fnbeh.2016.00124. eCollection 2016.
- Related InfoLink provided by the sponsor.
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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.
Britta K Holzel, PhD principal investigator
Massachusetts General Hospital
Mohammed R Milad, PhD principal investigator
Massachusetts General 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 course in people with Healthy Individuals and Highly Stressed, run by Massachusetts General 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 1 inclusion and 4 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 7 May 2012. 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?
change in MRI data (time frame: pre and post intervention or wait period; first set of MRIs within 3 weeks before the course, second set of MRIs within 3 weeks after course; MRIs will take 1.5 hours each and will occur on 2 consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01320969, which also lists 1 linked publication.
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 7 May 2012.