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Completed

NCT Number: NCT01033851

Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Based Stress Reduction

Behavioral

8 week course

Stress Management Education

Behavioral

8 week course

Primary outcomes

  1. Active Symptoms of Generalized Anxiety Disorder

    Time frame: 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 outcomes

  1. Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.

    Time frame: 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).

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Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Dec 17, 2009
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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