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Mindfulness-Based Stress Reduction and Myocardial Ischemia

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ClinicalTrials.gov Identifier: NCT00224835
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE September 21, 2005
First Posted Date  ICMJE September 23, 2005
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE May 2003
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2007)
  • Psychological stress-induced ischemia (measured by radionuclide imaging at Week 9) [ Time Frame: After data collection is complete. ]
  • Heart rate variability (measured by AECG at Week 9) [ Time Frame: After data collection is complete ]
  • Peripheral artery response (measured by finger plethysmography at Week 9) [ Time Frame: After data collection is complete ]
  • 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. ]
  • Daily mood diaries (obtained at Weeks 7-8 and Weeks 20-21) [ Time Frame: After data collection is complete ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00224835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness-Based Stress Reduction and Myocardial Ischemia
Official Title  ICMJE Mindfulness-Based Stress Reduction and Myocardial Ischemia
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arteriosclerosis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms
  • Experimental: 1
    Mindfulness Based Stress Reduction Class
    Intervention: Behavioral: Mindfulness Based Stress Reduction Class
  • Experimental: 2
    Cardiac Education Class
    Intervention: Behavioral: Cardiac Education Class
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2013)
150
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00224835
Other Study ID Numbers  ICMJE 319
R01HL072059 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: David S Sheps, MD University of Florida
PRS Account University of Florida
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP