Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Generalized Anxiety Disorder

Treatments: Behavioral: Mindfulness Based Stress Reduction; Behavioral: Stress Management Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01033851

5K23AT004432 (U.S. NIH Grant/Contract)

2008-P-000275

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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89 participants in 2 patient groups

Mindfulness Based Stress Reduction

Active Comparator group

Description:

Mindfulness Based Stress Reduction (MBSR) is an 8-week group intervention that trains participants in mindfulness meditation techniques.

Treatment:

Behavioral: Mindfulness Based Stress Reduction

Stress Management Education

Active Comparator group

Description:

Stress Management Education (SME) is an 8-week group intervention that educates participants about stress physiology and health lifestyle changes.

Treatment:

Behavioral: Stress Management Education