Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

Massachusetts General Hospital89 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Generalized Anxiety Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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.

Time frame: 2 months

Secondary Outcomes

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).