Behavioral Clinical Trials for Chronic Diseases

1. Front Matter

   Pages i-xviii

   PDF

2. Introduction

   • Lynda H. Powell, Peter G. Kaufmann, Kenneth E. Freedland

   Pages 1-10

3. Quality of a Clinical Trial

   • Lynda H. Powell, Peter G. Kaufmann, Kenneth E. Freedland

   Pages 11-25

4. Behavioral Treatment Development

   • Lynda H. Powell, Peter G. Kaufmann, Kenneth E. Freedland

   Pages 27-68

5. Hypothesized Pathway and Bias

   • Lynda H. Powell, Peter G. Kaufmann, Kenneth E. Freedland

   Pages 69-96

6. Clinical Significance

   • Lynda H. Powell, Peter G. Kaufmann, Kenneth E. Freedland

   Pages 97-124

7. The Choice of a Comparator

   • Lynda H. Powell, Peter G. Kaufmann, Kenneth E. Freedland

   Pages 125-146

8. Feasibility and Pilot Studies

   • Lynda H. Powell, Peter G. Kaufmann, Kenneth E. Freedland

   Pages 147-167

9. Protection of Random Assignment

   • Lynda H. Powell, Peter G. Kaufmann, Kenneth E. Freedland

   Pages 169-207

10. Outcomes

    • Lynda H. Powell, Peter G. Kaufmann, Kenneth E. Freedland

    Pages 209-236

11. Preferences, Equipoise, and Blinding

    • Lynda H. Powell, Peter G. Kaufmann, Kenneth E. Freedland

    Pages 237-260

12. The Future of Behavioral Randomized Clinical Trials

    • Lynda H. Powell, Peter G. Kaufmann, Kenneth E. Freedland

    Pages 261-279

13. Epilogue

    • Lynda H. Powell, Peter G. Kaufmann, Kenneth E. Freedland

    Pages 281-284

14. Back Matter

    Pages 285-314

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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.

• behavioral randomized clinical trials
• clinically significant behavioral health benefit
• clinically significant behavioral health problem
• practical aspects of behavioral clinical trial design
• principles of behavioral clinical trial design
• strategy of RCTs

• Department of Preventive Medicine, Rush University Medical Center, Chicago, USA

  Lynda H. Powell

• Department of Psychiatry, Washington University in St. Louis, St. Louis, USA

  Kenneth E. Freedland

• College of Nursing, Villanova University, Villanova, USA

  Peter G. Kaufmann

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.

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