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Mindfulness-Based Stress Reduction and Myocardial Ischemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00224835
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : May 13, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Florida

Brief Summary:

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:

  1. In comparison to either of the control conditions, significantly more coronary artery disease (CAD) patients in the mindfulness meditation condition will demonstrate reductions in mental stress-induced ischemia.
  2. The ratio of low-to-high frequency of spectral power in heart rate variability during ambulatory monitoring will be significantly decreased following the participation in a stress reduction program compared with those in a disease education or usual care condition.
  3. Patients in the mindfulness meditation condition will report greater improvement in quality of life (i.e., reductions in general psychological symptomology, anger, anxiety, depression, and daily stress, along with increases in optimism and stress coping efficacy) than patients in either of the control conditions.
  4. Day-to-day variability in self-reported mental stress will be inversely related to day-to-day stress coping efficacy in the entire sample and time spent in mindfulness practice in the active treatment condition, and these relationships will be maintained over a 3-month follow-up.
  5. 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.

    • Abnormal responses will be defined as peripheral arterial tonometry (PAT) tracings that decrease greater than 20% in amplitude during mental stress.

Condition or disease Intervention/treatment Phase
Arteriosclerosis Behavioral: Mindfulness Based Stress Reduction Class Behavioral: Cardiac Education Class Not Applicable

Detailed Description:


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.


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness-Based Stress Reduction and Myocardial Ischemia
Study Start Date : May 2003
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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.

Experimental: 2
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.

Primary Outcome Measures :
  1. Psychological stress-induced ischemia (measured by radionuclide imaging at Week 9) [ Time Frame: After data collection is complete. ]
  2. Heart rate variability (measured by AECG at Week 9) [ Time Frame: After data collection is complete ]
  3. Peripheral artery response (measured by finger plethysmography at Week 9) [ Time Frame: After data collection is complete ]
  4. Psychological functioning (degree of depression measured by Beck Depression Inventory (BDI), anxiety by STAI, hostility by Cook-Medley Index, anger by STAXI, optimism by LOT-R, and quality of life/functional status by SF-36 at Weeks 9 and 20) [ Time Frame: Results of BDI will be assessed immediately after the participant completes the form. All other questionnaires will be assessed after data collection is complete. ]
  5. Daily mood diaries (obtained at Weeks 7-8 and Weeks 20-21) [ Time Frame: After data collection is complete ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 18 years old
  • Confirmed CAD--the clinical diagnosis of coronary disease will be defined by the presence of at least one of the following: 1) abnormal coronary angiogram; 2) abnormal intravascular ultrasound (IVUS); or 3) abnormal flow reserve and documentation of one of the following: 1) elevated troponin laboratory values typical for myocardial infarction; 2) electrocardiogram (ECG) that shows q-wave abnormalities; 3) nuclear scan that demonstrates a fixed wall motion abnormality consistent with an old myocardial infarct; 4) greater than 95% probability of coronary disease according to the criteria of Diamond and Forrester.102; 5) radionuclide study, dobutamine, or exercise echocardiographic study consistent with stress-induced ischemia (development of segmental wall motion abnormalities or reversible perfusion defects on radionuclide imaging and/or wall motion or systolic thickening abnormalities on stress echocardiographic exam)

Exclusion Criteria:

  • Current pregnancy or probability of pregnancy during the duration of the 12-week study
  • Diagnosis of unstable angina in the prior 2 months
  • Presence of other severe, complicating medical problems that will significantly shorten the patients' life expectancy such that they will not be expected to live for the 12 weeks of this study
  • Presence of serious psychopathology evidenced by BDI scores that indicate a clinically critical level of depression (score of 24 or above) with suicidal ideation; previous diagnosis of an organic mental disorder, schizophrenia, or any psychotic disorder; or psychiatric inpatient at any time during the last 5 years (if patients are excluded on the basis of depression scores indicating severe depression or suicidal ideation, referral for psychological services will be offered)
  • Post-traumatic stress disorder (PTSD) greater than the 30% VA disability assignment (patients with less severe PTSD will be encouraged to participate)
  • Existing meditation practice
  • Weight more than 400 pounds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00224835

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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: David S Sheps, MD University of Florida

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Responsible Party: University of Florida Identifier: NCT00224835    
Other Study ID Numbers: 319
R01HL072059 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases