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Does Mindfulness Training Change the Processing of Social Threat?

This study has been completed.
Sponsor:
Collaborators:
Mind and Life Institute, Hadley, Massachusetts
European Commission
Information provided by (Responsible Party):
Britta Holzel, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00992875
First received: September 28, 2009
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Healthy
Stress
Behavioral: Mindfulness-Based Stress Reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Does Mindfulness Training Change the Processing of Social Threat?

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • BOLD signal on a 1.5T MRI scanner [ Time Frame: the second time-point will take place eight weeks after the first data collection ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Mindfulness-Based Stress Reduction
    Behavioral intervention, mindfulness meditation in form of yoga, sitting meditation, body scan and mindfulness to routine activities
  Eligibility

Ages Eligible for Study:   22 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992875

Locations
United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Mind and Life Institute, Hadley, Massachusetts
European Commission
Investigators
Principal Investigator: Sara W Lazar, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Britta Holzel, Research Fellow, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00992875     History of Changes
Other Study ID Numbers: 2008A057212, FP7-PEOPLE-IOF-2008: 236975
Study First Received: September 28, 2009
Last Updated: May 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Healthy but stressed individuals

ClinicalTrials.gov processed this record on November 20, 2014