Enhancing standard cardiac rehabilitation with stress management training: background, methods, and design for the enhanced study.
OBJECTIVE
Enhancing Standard Cardiac Rehabilitation with Stress Management Training in Patients with Heart Disease (ENHANCED) is a randomized clinical trial funded by the National Heart Lung and Blood Institute to evaluate the effects of stress management training (SMT) on changes in biomarkers of risk and quality of life for patients enrolled in traditional exercise-based cardiac rehabilitation (CR).


METHODS
One hundred fifty cardiac patients recruited from Duke University and the University of North Carolina will be evaluated and randomized to CR enhanced by SMT (including sessions devoted to relaxation training, cognitive restructuring, communication skills, and problem solving) or to standard exercise-based CR. Before and after 12 weeks of treatment, patients will undergo a battery of psychometric questionnaires and evaluation of cardiovascular biomarkers, including measures of flow-mediated dilation, heart rate variability, baroreflex sensitivity, platelet function and inflammation, and ischemia during laboratory mental stress testing. The primary outcomes include a composite measure of stress (distress, depression, anxiety, and hostility and 24-hour urinary catecholamines and cortisol) and a composite measure of cardiac biomarkers of risk (vascular endothelial function, cardiac vagal control, inflammation, platelet function, and mental stress-induced myocardial ischemia). Secondary outcomes include measures of quality of life as well as clinical events, including death, hospitalizations, myocardial infarction, and revascularization procedures.


RESULTS
This article reviews prior studies in the area and describes the design of the ENHANCED study. Several key methodological issues are discussed including the assessment of biomarkers of risk and barriers to the integration of SMT into traditional CR.


CONCLUSIONS
The ENHANCED study will provide important information by determining to what extent SMT combined with exercise-based CR may improve prognosis and quality of life in vulnerable cardiac patients.
Blumenthal
James A
JA
Department of Psychiatry and Behavioral Sciences, PO Box 3119, Duke University Medical Center, Durham, NC 27710, USA. Blume003@mc.duke.edu
Wang
Jenny T
JT
Babyak
Michael
M
Watkins
Lana
L
Kraus
William
W
Miller
Paula
P
Hinderliter
Alan
A
Sherwood
Andrew
A
D000223:Adaptation, Psychological; D000328:Adult; D015415:Biomarkers; D003324:Coronary Artery Disease / Q000523:psychology / Q000534:rehabilitation* / Q000628:therapy; D004730:Endothelium, Vascular; D005260:Female; D006339:Heart Rate; D006801:Humans; D007249:Inflammation; D057194:Intention to Treat Analysis; D008297:Male; D017202:Myocardial Ischemia; D010979:Platelet Function Tests; D011594:Psychometrics; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D013315:Stress, Psychological / Q000150:complications / Q000628:therapy*; D011795:Surveys and Questionnaires
D015415:Biomarkers