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OpenTrials
Completed

NCT Number: NCT01320969

Could Meditation Modulate the Neurobiology of Learning Not to Fear?

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Mindfulness-Based Stress Reduction course

Behavioral

an eight-week mindfulness-based stress reduction course

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • John Templeton Foundation
  • Mind and Life Institute, Hadley, Massachusetts
  • University of Pennsylvania

Registry information

Official study title

Effects of Mindfulness Practice on the Neural Circuitry of Conditioned Fear Extinction in Healthy Participants

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 23, 2011
Registry last updated
May 7, 2012

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.

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