Mindfulness-Based Stress Reduction and Myocardial Ischemia
Condition: Arteriosclerosis
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Arteriosclerosis; Ischemia
Study type: Interventional

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.
    

Intervention name(s): Mindfulness Based Stress Reduction Class; Cardiac Education Class
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects randomized to this condition will attend 120 minute weekly sessions, plus a 7 hour retreat, for training in mindfulness meditation methods.; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment