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Could Meditation Modulate the Neurobiology of Learning Not to Fear?

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ClinicalTrials.gov Identifier: NCT01320969
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : May 7, 2012
Sponsor:
Collaborators:
University of Pennsylvania
John Templeton Foundation
Mind and Life Institute, Hadley, Massachusetts
Information provided by (Responsible Party):
Britta Holzel, Massachusetts General Hospital

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Individuals Highly Stressed Behavioral: Mindfulness-Based Stress Reduction course Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Mindfulness Practice on the Neural Circuitry of Conditioned Fear Extinction in Healthy Participants
Study Start Date : December 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Mindfulness-Based Stress Reduction course
an eight week mindfulness-based stress reduction course
 Behavioral: Mindfulness-Based Stress Reduction course
an eight-week mindfulness-based stress reduction course
No Intervention: Waitlist group
waitlist group


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    questionnaire data will also be collected pre and post the intervention / wait period; change in the scores will be assessed


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320969


Locations
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United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
University of Pennsylvania
John Templeton Foundation
Mind and Life Institute, Hadley, Massachusetts
Investigators
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Principal Investigator: Britta K Holzel, PhD Massachusetts General Hospital
Principal Investigator: Mohammed R Milad, PhD Massachusetts General Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Britta Holzel, Research Fellow, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01320969    
Other Study ID Numbers: 2010-P-002025
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012
Keywords provided by Britta Holzel, Massachusetts General Hospital:
mindfulness, fear conditioning