Mindfulness-Based Stress Reduction and Myocardial Ischemia

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.

Conditions

• Arteriosclerosis

Interventions

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Florida

  lead OTHER

Principal Investigators

• David S Sheps, MD · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-05-31

Primary Completion

2008-08-31

Completion

2008-08-31

Countries

• United States

Study Locations