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Clinical Trials/NCT01033851
NCT01033851
Completed
Phase 4

Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

Massachusetts General Hospital1 site in 1 country89 target enrollmentMarch 2008

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Generalized Anxiety Disorder
Sponsor
Massachusetts General Hospital
Enrollment
89
Locations
1
Primary Endpoint
Active Symptoms of Generalized Anxiety Disorder
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Current therapies for Generalized Anxiety Disorder (GAD) have limited effectiveness. This study measures the efficacy of two different approaches to reducing anxiety and stress. One approach uses education, nutrition, exercise, and time management training, and another uses mindfulness meditation and yoga, which is taught as part of the Mindfulness-based stress reduction (MBSR) course, an 8-week manualized mindfulness intervention. We hypothesize that the two approaches will reduce anxiety in individuals with GAD in different ways. We will measure changes in stress hormones associated with these changes.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
February 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elizabeth A. Hoge, MD

Assistant Psychiatrist

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Adults with generalized anxiety disorder
  • medically healthy

Exclusion Criteria

  • substance abuse
  • history of other psychiatric diagnoses such as psychosis, Obsessive Compulsive Disorder, PTSD
  • use of certain types of psychotherapy, meditation training, yoga
  • pregnant or lactating women

Outcomes

Primary Outcomes

Active Symptoms of Generalized Anxiety Disorder

Time Frame: 2 months

The Hamilton Anxiety Scale (HAMA) was defined as the primary anxiety outcome variable. This scale has 14 items describing symptoms of anxiety, each answered on a 0-4 scale, with 0 for a single question generally representing no symptoms, and 4 representing severe levels of the symptom. The total score is calculated by adding all the items together, for a possible total score of 0 to 56.

Secondary Outcomes

  • Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.(2 months)

Study Sites (1)

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