Back to resultsStress Reduction and Anxiety: Effects on the Function and Structure of the Brain
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Reduction Intervention
Active Control intervention
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
Eligibility Criteria
Inclusion Criteria:
- participation in the study 'Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects" by Dr. Elizabeth Hoge
Exclusion Criteria:
- metallic implants
- left handed
- epileptic seizures
- head trauma
- weight over 350 pounds
- claustrophobia
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stress Reduction Intervention
Active Control Condition
Arm Description
Stress Reduction Intervention
Outcomes
Primary Outcome Measures
brain activation and structure as assessed by MRI
BOLD functional MRI and structural MRI
brain activation and structure as assessed by MRI
BOLD functional MRI and structural MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT01128309
First Posted
May 19, 2010
Last Updated
May 4, 2012
Sponsor
Massachusetts General Hospital
Collaborators
European Commission
1. Study Identification
Unique Protocol Identification Number
NCT01128309
Brief Title
Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain
Official Title
Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
European Commission
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to test whether Generalized Anxiety Disorder (GAD) patients that participate in a Stress Reduction Intervention show a brain activation pattern (assessed by MRI) indicative of improved emotion regulation compared to an active control intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stress Reduction Intervention
Arm Type
Experimental
Arm Description
Stress Reduction Intervention
Arm Title
Active Control Condition
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Stress Reduction Intervention
Intervention Description
eight week group program, plus daily homework practice
Intervention Type
Behavioral
Intervention Name(s)
Active Control intervention
Intervention Description
weekly group meetings for eight weeks, plus daily homework practice
Primary Outcome Measure Information:
Title
brain activation and structure as assessed by MRI
Description
BOLD functional MRI and structural MRI
Time Frame
Day 1 (within two weeks before the intervention)
Title
brain activation and structure as assessed by MRI
Description
BOLD functional MRI and structural MRI
Time Frame
Day 2 (within two weeks after the intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participation in the study 'Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects" by Dr. Elizabeth Hoge
Exclusion Criteria:
metallic implants
left handed
epileptic seizures
head trauma
weight over 350 pounds
claustrophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara W Lazar, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Britta K Holzel, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
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Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain
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