Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

Phase 4

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Behavioral: Mindfulness Based Stress Reduction; Behavioral: Stress Management Education

• Registration Number: NCT01033851
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-17
• Primary Completion: 2012-01
• Study Completion: 2013-02
• Results First Submitted: 2013-02-21
• Results First Submitted QC: 2013-05-07
• Results First Posted: 2013-06-11
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-29
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Based Stress Reduction	Mindfulness Based Stress Reduction	Mindfulness Based Stress Reduction (MBSR) is an 8-week group intervention that trains participants in mindfulness meditation techniques.
Stress Management Education	Stress Management Education	Stress Management Education (SME) is an 8-week group intervention that educates participants about stress physiology and health lifestyle changes.

Primary Outcome Measures

Name	Time	Method
Active Symptoms of Generalized Anxiety Disorder	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 Outcome Measures

Name	Time	Method
Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.	2 months	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).

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States