Mindfulness-Based Stress Reduction and Myocardial Ischemia
Public ClinicalTrials.gov record NCT00224835. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00224835
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Interventions
- Mindfulness Based Stress Reduction Class Behavioral
- Cardiac Education Class Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2003
- Primary completion
- Jul 31, 2008
- Completion
- Jul 31, 2008
- Last update posted
- May 12, 2016
2003 – 2008
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00224835, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 12, 2016 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00224835 live on ClinicalTrials.gov.