Mindfulness-Based Stress Reduction and Myocardial Ischemia
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/14/2016 |
| Start Date: | May 2003 |
| End Date: | August 2008 |
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.
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.
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.
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.
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
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