Neural Correlates of Stress Reduction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sara W Lazar, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01488422
First received: December 5, 2011
Last updated: January 14, 2015
Last verified: January 2015

December 5, 2011
January 14, 2015
December 2011
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01488422 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Neural Correlates of Stress Reduction
Structural and Functional Mechanisms of Stress Reduction

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Stress
  • Psychological Stress
  • Life Stress
  • Emotional Stress
  • Social Stress
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 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.
    Intervention: Behavioral: Stress Reduction
  • 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.
    Intervention: Behavioral: Stress Reduction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01488422
AT006344
No
Sara W Lazar, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Sara Lazar, PhD Massachusetts General Hospital
Massachusetts General Hospital
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP