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Neural Correlates of Stress Reduction

This study is currently recruiting participants.
Verified December 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Sara Whitney Lazar, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01488422
First received: December 5, 2011
Last updated: December 31, 2012
Last verified: December 2012
History of Changes
  Purpose

This study will identify neural mechanisms associated with changes in emotion regulation following participation in stress reduction programs.


Condition Intervention
Stress
Psychological Stress
Life Stress
Emotional Stress
Social Stress
 Behavioral: Stress Reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Structural and Functional Mechanisms of Stress Reduction

Resource links provided by NLM:

MedlinePlus related topics: Stress
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Changes in gray matter structure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Study participants will undergo an MRI scan before and after attending an 8-week stress reduction program.


Secondary Outcome Measures:
  • Emotion regulation [ Time Frame: 8-weeks ] [ Designated as safety issue: No ]
    Study participants will do an emotion regulation task while they are in the MRI scanner. We will assess brain activity and skin conductance during the task. Changes in these measures will be assessed before and after enrollment in the stress reduction program


Estimated Enrollment: 90
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Both groups will receive stress reduction materials. We expect both groups to achieve similar amounts of stress reduction, but to use different brain regions to do so.
 Behavioral: Stress Reduction
We are comparing 2 well-studied approaches to stress reduction. All participants will receive stress reduction instructions that have already been proven to effectively reduce stress. Our goal is to compare the neural mechanisms associated with both approaches.
Active Comparator: Group 2
Both groups will receive stress reduction materials. We expect both groups to achieve similar amounts of stress reduction, but to use different brain regions to do so.
 Behavioral: Stress Reduction
We are comparing 2 well-studied approaches to stress reduction. All participants will receive stress reduction instructions that have already been proven to effectively reduce stress. Our goal is to compare the neural mechanisms associated with both approaches.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-50 years of age
  • Right-handed
  • Stressed

Exclusion Criteria:

  • Lifetime history of schizophrenia or psychosis
  • Psychiatric illness
  • History of seizure or significant head trauma
  • Use of psychotropic medications
  • Metallic implants or devices contraindicating magnetic resonance imaging
  • Claustrophobia
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488422

Contacts
Contact: Study Coordinator 617-643-9216 stressreduction@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Sara Lazar, PhD Massachusetts General Hospital
  More Information

Additional Information:
More information and to contact us directly  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sara Whitney Lazar, Associate Research Scientist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01488422     History of Changes
Other Study ID Numbers: AT006344
Study First Received: December 5, 2011
Last Updated: December 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 19, 2013