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.

Cardiovascular disease continues to be the number ioral medicine" was developed and shaped into the one source of morbidity and mortality in our coun- following definition: try. Despite a 35% reduction since 1964, these Behavioral medicine is the interdisciplinary field con- diseases, particularly coronary heart disease cerned with the development and integration of behav- (CHD), claim nearly 1,000,000 lives each year in ioral and biomedical science knowledge and techniques the United States (Havlik & Feinleib, 1979). relevant to the understanding of health and illness and The Framingham study, among others, has iden- the application of this knowledge and these techniques to prevention, diagnosis, treatment and rehabilitation. tified three major risk factors implicated in the de- (Schwartz & Weiss, 1978) velopment of CHD: smoking, elevated serum cho- lesterol, and high blood pressure (Castelli et at., This concept of "biobehavioral" collaboration 1986). Given that these factors account for less challenged scientists and clinicians of many disci- than 50% of the variance associated with CHD plines to consider how they might more effectively (Jenkins, 1976), it has become obvious that addi- develop diagnostic, treatment, and prevention tional risk factors must be identified if further pro- strategies by merging their perspectives to address gress is to be made in disease prevention and simultaneously, among others, behavioral, psy- control.

Cardiovascular disease continues to be the number ioral medicine" was developed and shaped into the one source of morbidity and mortality in our coun- following definition: try. Despite a 35% reduction since 1964, these Behavioral medicine is the interdisciplinary field con- diseases, particularly coronary heart disease cerned with the development and integration of behav- (CHD), claim nearly 1,000,000 lives each year in ioral and biomedical science knowledge and techniques the United States (Havlik & Feinleib, 1979). relevant to the understanding of health and illness and The Framingham study, among others, has iden- the application of this knowledge and these techniques to prevention, diagnosis, treatment and rehabilitation. tified three major risk factors implicated in the de- (Schwartz & Weiss, 1978) velopment of CHD: smoking, elevated serum cho- lesterol, and high blood pressure (Castelli et at., This concept of "biobehavioral" collaboration 1986). Given that these factors account for less challenged scientists and clinicians of many disci- than 50% of the variance associated with CHD plines to consider how they might more effectively (Jenkins, 1976), it has become obvious that addi- develop diagnostic, treatment, and prevention tional risk factors must be identified if further pro- strategies by merging their perspectives to address gress is to be made in disease prevention and simultaneously, among others, behavioral, psy- control.