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NCT01128309 Clinical Trial

Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain

Generalized Anxiety Disorder Clinical Trial

Official title:
Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01128309
Other study ID # 2010P000947
Secondary ID 236975
Status Completed
Phase N/A
First received May 19, 2010
Last updated May 4, 2012
Start date May 2010
Est. completion date April 2011

Study information
Verified date May 2012
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Stress Reduction Intervention
eight week group program, plus daily homework practice
• Active Control intervention
weekly group meetings for eight weeks, plus daily homework practice

Locations
Country Name City State
United States Massachusetts General Hospital Charlestown Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Massachusetts General Hospital European Commission

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary brain activation and structure as assessed by MRI BOLD functional MRI and structural MRI Day 1 (within two weeks before the intervention) No
Primary brain activation and structure as assessed by MRI BOLD functional MRI and structural MRI Day 2 (within two weeks after the intervention) No
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