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Neural Correlates of Stress Reduction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01488422
First Posted: December 8, 2011
Last Update Posted: January 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sara W Lazar, Massachusetts General Hospital
  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: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Structural and Functional Mechanisms of Stress Reduction

Further study details as provided by Sara W Lazar, Massachusetts General Hospital:

Primary Outcome Measures:
  • Changes in gray matter structure [ Time Frame: 8 weeks ]
    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 ]
    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


Enrollment: 140
Study Start Date: December 2011
Study Completion Date: December 2014
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488422


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

Additional Information:
Responsible Party: Sara W Lazar, Associate Research Scientist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01488422     History of Changes
Other Study ID Numbers: AT006344
First Submitted: December 5, 2011
First Posted: December 8, 2011
Last Update Posted: January 15, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms