Could Meditation Modulate the Neurobiology of Learning Not to Fear?

This study has been completed.
Sponsor:
Collaborators:
University of Pennsylvania
John Templeton Foundation
Mind and Life Institute
Information provided by (Responsible Party):
Britta Holzel, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01320969
First received: March 17, 2011
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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 Intervention
Healthy Individuals
Highly Stressed
Behavioral: Mindfulness-Based Stress Reduction course

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Mindfulness Practice on the Neural Circuitry of Conditioned Fear Extinction in Healthy Participants

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    questionnaire data will also be collected pre and post the intervention / wait period; change in the scores will be assessed


Enrollment: 85
Study Start Date: December 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320969

Locations
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
Investigators
Principal Investigator: Britta K Holzel, PhD Massachusetts General Hospital
Principal Investigator: Mohammed R Milad, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Britta Holzel, Research Fellow, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01320969     History of Changes
Other Study ID Numbers: 2010-P-002025
Study First Received: March 17, 2011
Last Updated: May 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
mindfulness, fear conditioning

ClinicalTrials.gov processed this record on April 15, 2014