Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 89
- Locations
- 2
- Primary Endpoint
- Active Symptoms of Generalized Anxiety Disorder
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Elizabeth A. Hoge, MD
Assistant Psychiatrist
Massachusetts General Hospital