Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
---|---|
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00224835 |
The principal objective of the study is to evaluate the effectiveness of a widely used complementary medicine intervention, mindfulness-based stress reduction (MBSR), in which mindfulness meditation and yoga are the principal components in the treatment of a chronic, often fatal illness that affects tens of millions of Americans. The investigators propose to conduct a single center randomized controlled trial in which 150 patients will be assigned to either a mindfulness meditation condition, a disease education control condition, or a stress-monitoring usual care control condition. They will test the following specific hypotheses:
Patients with CAD and mental stress ischemia who show an *abnormal peripheral artery response during baseline studies will show a significant improvement after mindfulness intervention.
Condition | Intervention |
---|---|
Arteriosclerosis |
Behavioral: Mindfulness Based Stress Reduction Class Behavioral: Cardiac Education Class |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment |
Official Title: | Mindfulness-Based Stress Reduction and Myocardial Ischemia |
Estimated Enrollment: | 200 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Mindfulness Based Stress Reduction Class
|
Behavioral: Mindfulness Based Stress Reduction Class
Subjects randomized to this condition will attend 120 minute weekly sessions, plus a 7 hour retreat, for training in mindfulness meditation methods.
|
2: Experimental
Cardiac Education Class
|
Behavioral: Cardiac Education Class
Subjects in the disease education control condition will attend 8 weekly 60 minute sessions, plus a 7 hour "special experience" session, all of which will provide information about CAD in a didactic format.
|
BACKGROUND:
Acute and chronic psychological stress has been shown to be a risk factor for cardiac events. More recently with the advent of new technology allowing cardiac imaging, acute psychological stressors have been shown to produce myocardial ischemia in certain subsets of patients with CAD. Several studies have shown that the production of myocardial ischemia in response to acute psychological stress in the laboratory is a marker for adverse events in patients with CAD. Several pathways by which psychologically induced stress may trigger ischemic events have been proposed, and a number of studies have provided evidence that stress affects ischemic events via these pathways. Stress interventions have been shown to have a positive impact on CAD outcomes, with only one thus far testing their effects on ischemic events. Furthermore, some studies have reported positive results with coronary risk factors using meditation and yoga. Current clinical meditation literature suggests that a mindfulness meditation-based stress reduction program (i.e., multicomponent, psychoeducational program based in mindfulness meditation that cultivates an ability to pay attention to one's moment-to-moment experiences in a nonjudgmental, nonreactive fashion) will be able to reduce stress reactivity in CAD patients. It is predicted that such reductions in stress reactivity will result in reduced radionuclide imaged perfusion defects during a laboratory mental stress task. Although it has not been used with heart patients, it has demonstrated good results with both stress and symptomology in the general and other medical populations. We believe that similar results will be seen in CAD patients with effects acting through the following pathways: 1) decreased sympathetic tone and 2) increased parasympathetic tone. The overall goal of the proposed study is to evaluate the efficacy of a meditation-based stress reduction program for the reduction of mental stress-induced ischemia.
DESIGN NARRATIVE:
To test the efficacy of MBSR, patients will be randomly assigned to one of three groups. The MBSR condition will be provided training in mindfulness meditation methods. The patient education control group will be provided information about CAD in a didactic format. This condition will control for the nonspecific effects of contact in a therapeutic setting. Excluding intervals spent in personal meditation practice in the mindfulness meditation condition, the length of sessions in the two intervention conditions will be approximately equal. The third group, a stress-monitoring usual care control condition, will control for the effects of symptom measurement reactivity in patients receiving routine medical care.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Melinda Bestland, RN | 352-376-1611 ext 6955 | melinda.bestland@medicine.ufl.edu |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32611 | |
Contact: Melinda Bestland, RN 352-376-1611 ext 6955 bestlmt@medicine.ufl.edu | |
Principal Investigator: David Sheps |
Responsible Party: | University of Florida ( David S. Sheps MD, MSPH ) |
Study ID Numbers: | 319 |
Study First Received: | September 21, 2005 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00224835 |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases |
Stress Ischemia Arteriosclerosis |
Cardiovascular Diseases |