Behavioral Treatment Development

Abstract

This chapter proposes a progressive, translational model for developing behavioral treatments for chronic diseases. It begins by describing the long-standing, evolving, and widely accepted process of drug development. It then draws on basic elements of this process to present the revised ORBIT model for developing behavioral treatments for chronic diseases. This model pushes toward Phase III behavioral efficacy testing in three progressive phases: (1) Discovery of an important clinical problem and a basic science underpinning for a behavioral treatment that could solve it; (2) Design of the treatment by first assembling basic elements and then refining them to enhance efficiency without sacrificing efficacy; and (3) Preliminary Testing of a fixed protocol using proof-of-concept studies, feasibility studies, and Phase II behavioral trials with behavioral and biomedical outcomes. Recommendations for fostering translational behavioral treatment research are suggested for funding agencies, publication practices, and investigators.

Derived from the Dutch verb quacken (to boast), “quack” is a word people use to describe medical charlatans. Quacks peddled adulterated and mislabeled medicines throughout the United States without penalty until 1906 when the Congress passed the Food and Drug Act that outlawed the practice [1]. In the United States, the Food and Drug Administration (FDA) regulates a vast array of products, including drugs, medical devices, and some dietary supplements, foods, and cosmetics. However, there is no regulation for medically indicated behavioral treatments for chronic diseases. Thus, it is difficult for consumers to distinguish between behavioral treatments that work and ineffective treatments promoted by behavioral “quacks.”

Appendix: Obesity-Related Behavioral Treatment Intervention Trials (ORBIT) Consortium

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