Back to resultsNeural Correlates of Stress Reduction
Primary Purpose
Stress, Psychological Stress, Life Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Reduction
Sponsored by
About this trial
This is an interventional basic science trial for Stress
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in gray matter structure
Study participants will undergo an MRI scan before and after attending an 8-week stress reduction program.
Secondary Outcome Measures
Emotion regulation
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
Full Information
NCT ID
NCT01488422
First Posted
December 5, 2011
Last Updated
January 14, 2015
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01488422
Brief Title
Neural Correlates of Stress Reduction
Official Title
Structural and Functional Mechanisms of Stress Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will identify neural mechanisms associated with changes in emotion regulation following participation in stress reduction programs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological Stress, Life Stress, Emotional Stress, Social Stress
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Stress Reduction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in gray matter structure
Description
Study participants will undergo an MRI scan before and after attending an 8-week stress reduction program.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Emotion regulation
Description
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
Time Frame
8-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Lazar, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31303261
Citation
Sevinc G, Holzel BK, Greenberg J, Gard T, Brunsch V, Hashmi JA, Vangel M, Orr SP, Milad MR, Lazar SW. Strengthened Hippocampal Circuits Underlie Enhanced Retrieval of Extinguished Fear Memories Following Mindfulness Training. Biol Psychiatry. 2019 Nov 1;86(9):693-702. doi: 10.1016/j.biopsych.2019.05.017. Epub 2019 May 30.
Results Reference
derived
Learn more about this trial
Neural Correlates of Stress Reduction
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