Coronary heart disease (CHD) is the leading cause of death in the United States, affecting 1 million people each year. The term "cardiovascular vulnerable patient" has been used to describe patients susceptible to acute coronary events based upon plaque, blood, or myocardial characteristics. Epidemiological studies have shown that stress is a significant and independent risk factor for patients with CHD, and also may be associated with increased cardiovascular vulnerability. This evidence has provided a rationale for developing stress management training (SMT) interventions for CHD patients. Although cardiac rehabilitation (CR) is regarded as integral to the care of patients with CHD, SMT is currently not an essential component of most CR programs. We believe that the therapeutic potential of SMT has remained unfulfilled due to a paucity of well- designed clinical studies in CHD patients. Because randomized clinical trials (RCTs) employing "hard endpoints"-death or myocardial infarction-require large samples followed over long time intervals, such approaches are generally not feasible for most psychosocial RCTs. This application was developed in response to Program Announcement (PA-07-322), which invited proposals to examine the efficacy of SMT in improving intermediate outcomes, defined by biomarkers of cardiovascular risk purported to be in the pathway through which mental stress is thought to influence clinical events. The study proposed in this application will build upon our previous work in which we demonstrated the feasibility and efficacy of SMT in cardiovascular patients with stable CHD. Specifically, we propose to (a) evaluate the effectiveness of SMT combined with exercise-based CR in reducing stress in vulnerable cardiac patients;(b) examine changes in intermediate endpoints, including measures of cardiac vagal control, vascular endothelial dysfunction, inflammation, platelet function, and mental stress-induced myocardial ischemia, which are recognized biomarkers of cardiac vulnerability to clinical CHD events;(c) explore potential moderators and mediators by which SMT may improve biomarkers of risk;and (d) determine the impact of SMT on clinical endpoints over a mean follow-up period of 30 months. One hundred fifty men and women with CHD will be randomly assigned to exercise- based CR or to SMT-enhanced CR. Before and after 3 months of treatment, patients will undergo clinical assessments of stress and biomarkers of cardiovascular risk. Follow-up assessments will determine the maintenance of benefit and document cardiac events. The data generated from this study will have important clinical significance by determining the extent to which SMT combined with exercise-based CR reduces stress and improves prognosis in vulnerable cardiac patients.

Public Health Relevance

Coronary Heart Disease (CHD) is a significant health problem in the United States and throughout the world, and is the leading cause of death for men and women in the US. This study will examine the effects of a Stress Management Training program combined with exercise-based cardiac rehabilitation on cardiovascular biomarkers of risk and event-free survival in CHD patients.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL093374-04
Application #
8296630
Study Section
Psychosocial Risk and Disease Prevention Study Section (PRDP)
Program Officer
Stoney, Catherine
Project Start
2009-09-01
Project End
2014-11-30
Budget Start
2012-12-01
Budget End
2013-11-30
Support Year
4
Fiscal Year
2013
Total Cost
$703,055
Indirect Cost
$222,933
Name
Duke University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Sherwood, Andrew; Blumenthal, James A; Smith, Patrick J et al. (2016) Effects of Exercise and Sertraline on Measures of Coronary Heart Disease Risk in Patients With Major Depression: Results From the SMILE-II Randomized Clinical Trial. Psychosom Med 78:602-9
Parikh, Kishan S; Coles, Adrian; Schulte, Phillip J et al. (2016) Relation of Angina Pectoris to Outcomes, Quality of Life, and Response to Exercise Training in Patients With Chronic Heart Failure (from HF-ACTION). Am J Cardiol 118:1211-1216
Blumenthal, James A; Sherwood, Andrew; Smith, Patrick J et al. (2016) Enhancing Cardiac Rehabilitation With Stress Management Training: A Randomized, Clinical Efficacy Trial. Circulation 133:1341-50
Stonerock, Gregory L; Blumenthal, James A (2016) Role of Counseling to Promote Adherence in Healthy Lifestyle Medicine: Strategies to Improve Exercise Adherence and Enhance Physical Activity. Prog Cardiovasc Dis :
Mentz, Robert J; Babyak, Michael A; Bittner, Vera et al. (2015) Prognostic significance of depression in blacks with heart failure: insights from Heart Failure: a Controlled Trial Investigating Outcomes of Exercise Training. Circ Heart Fail 8:497-503
Stonerock, Gregory L; Hoffman, Benson M; Smith, Patrick J et al. (2015) Exercise as Treatment for Anxiety: Systematic Review and Analysis. Ann Behav Med 49:542-56
Ingle, Krista K; Blumenthal, James A (2012) Should stress management be incorporated into cardiac rehabilitation? Expert Rev Cardiovasc Ther 10:135-7
Blumenthal, James A (2011) New frontiers in cardiovascular behavioral medicine: comparative effectiveness of exercise and medication in treating depression. Cleve Clin J Med 78 Suppl 1:S35-43
Wang, Jenny T; Hoffman, Benson; Blumenthal, James A (2011) Management of depression in patients with coronary heart disease: association, mechanisms, and treatment implications for depressed cardiac patients. Expert Opin Pharmacother 12:85-98
Blumenthal, James A; Wang, Jenny T; Babyak, Michael et al. (2010) Enhancing standard cardiac rehabilitation with stress management training: background, methods, and design for the enhanced study. J Cardiopulm Rehabil Prev 30:77-84

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