Neural Correlates of Stress Reduction
This study is currently recruiting participants.
Verified December 2012 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
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
| Tracking Information | |||||
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| First Received Date ICMJE | December 5, 2011 | ||||
| Last Updated Date | December 31, 2012 | ||||
| Start Date ICMJE | December 2011 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01488422 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neural Correlates of Stress Reduction | ||||
| Official Title ICMJE | Structural and Functional Mechanisms of Stress Reduction | ||||
| Brief Summary | This study will identify neural mechanisms associated with changes in emotion regulation following participation in stress reduction programs. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 90 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01488422 | ||||
| Other Study ID Numbers ICMJE | AT006344 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sara Whitney Lazar, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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