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This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to "speak the language of medicine" through the conduct of high-quality behavioral clinical trials that match the rigor commonly seen in double-blind drug trials. It is relevant for testing any treatment aimed at improving a behavioral, social, psychosocial, environmental, or policy-level risk factor for a chronic disease including, for example, obesity, sedentary behavior, adherence to treatment, psychosocial stress, food deserts, and fragmented care. Outcomes of interest are those that are of clinical significance in the treatment of chronic diseases, including standard risk factors such as cholesterol, blood pressure, and glucose, and clinical outcomes such as hospitalizations, functional limitations, excess morbidity, quality of life, and mortality. This link between behavior and chronic disease requires innovative clinical trial methods not only from the behavioral sciences but also from medicine, epidemiology, and biostatistics. This integration does not exist in any current book, or in any training program, in either the behavioral sciences or medicine.
List of contents
Introduction: the window of opportunity.- A selected history of randomized behavioral clinical trials: what we learned.- A clinically significant problem and a clincially significant benefit.- The process of developing a behavioral treatment for chronic disease.- The hypothesized pathway from behavioral treatment to chronic disease.- Equipoise, blinding, and investigator discipline.- Sensitivity to diversity.- Protection of randomization.- Choice of appropriate control group.- Readiness to conduct a behavioral randomized clinical trial.- Concluding remarks.
About the author
Linda Powell, PhD is chair of the Department of Preventive Medicine and the Charles J and Margaret Roberts Professor of Preventive Medicine, Medicine (Cardiology), Behavioral Sciences, and Pharmacology at Rush Medical College. She received her doctoral degree at Stanford University, conducted post-doctoral work in cardiovascular epidemiology at the University of California San Francisco, and began her academic career at Yale University's School of Public Health. Her research interests are dietary and other preventive risk factors in the development of chronic disesaes and problems of older persons, including Alzheimer's disease, cognitive decline, and cardiovascular diseases. Dr. Powell is an internationally recognized expert in the conduct of behavioral clinical trials aimed at changing behavior as a way to reduce risk of chronic disease. She is a member of the Society of Behavioral Medicine and the American Psychiatric Association.
