Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

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.

Official Title
-----------------
Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

Conditions
-----------------
Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Based Stress Reduction
* Behavioral: Stress Management Education


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness Based Stress Reduction<br>Mindfulness Based Stress Reduction (MBSR) is an 8-week group intervention that trains participants in mindfulness meditation techniques. | Behavioral: Mindfulness Based Stress Reduction<br>* 8 week course<br>|
| Active Comparator: Stress Management Education<br>Stress Management Education (SME) is an 8-week group intervention that educates participants about stress physiology and health lifestyle changes. | Behavioral: Stress Management Education<br>* 8 week course<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active Symptoms of Generalized Anxiety Disorder | 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms. | This is an overal clinical measure of anxiety symptoms after examining and interviewing the patient. The scale is one global item, that scores from 1 (1= not ill at all) to 7 (7= among the most extremely ill). | 2 months |