Does Mindfulness Training Change the Processing of Social Threat?
2 other identifiers
interventional
28
1 country
1
Brief Summary
Training in mindfulness, the non-judgmental observation of experiences as they arise in the present moment, has been increasingly and successfully applied to the treatment of normative stress conditions and mental disorders. Yet, the neurological mechanisms that underlie the reported improvements are still largely unknown. This longitudinal study will investigate the influence of mindfulness training on a key underpinning of mental health, namely emotion regulation, and its associated brain activity. Healthy participants will be randomly assigned to either a validated eight week Mindfulness-based stress reduction (MBSR) program or to a control condition. In a pre-post investigation, participants' subjective reactions to aversive emotional stimuli (affective facial expressions) will be assessed, as will the associated brain activation using functional magnetic resonance imaging (fMRI). The investigators hypothesize that after the training the MBSR participants will rate the pictures as less aversive compared to control participants. Furthermore, the MBSR participants will show a patter of brain activation indicative of improved emotion regulation, relative to control participants. Finally, the effect of MBSR on the gray matter structure of the brain will be investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jan 2009
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 28, 2009
CompletedFirst Posted
Study publicly available on registry
October 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedMay 7, 2012
May 1, 2012
2.1 years
September 28, 2009
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BOLD signal on a 1.5T MRI scanner
the second time-point will take place eight weeks after the first data collection
Interventions
Behavioral intervention, mindfulness meditation in form of yoga, sitting meditation, body scan and mindfulness to routine activities
Eligibility Criteria
You may qualify if:
- no previous significant meditation or yoga experience
- eligible for MRI scanning (no metallic implants, not pregnant, not claustrophobic)
- no significant previous meditation or yoga experience
You may not qualify if:
- DSM-IV diagnosis for depression, manic episodes, GAD, social phobia, anorexia, bulimia, schizophrenia, ADHD, substance dependency/abuse, suicidality
- ineligible for MRI scanning (metallic implants, pregnant, claustrophobic)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Mind and Life Institute, Hadley, Massachusettscollaborator
- European Commissioncollaborator
Study Sites (1)
Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara W Lazar, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Fellow
Study Record Dates
First Submitted
September 28, 2009
First Posted
October 9, 2009
Study Start
January 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
May 7, 2012
Record last verified: 2012-05