Phase 4
N=89
Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01033851 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Active Symptoms of Generalized Anxiety Disorder — 13.65; 16.27 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mindfulness Based Stress Reduction (Behavioral); Stress Management Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Active Symptoms of Generalized Anxiety Disorder |
13.65; 16.27 | — |
| SECONDARY Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms. |
3.15; 3.58 | 0.0366 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT01033851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.