Similarities and important distinctions between drug and behavioral intervention development.

Abstract

There has been a proliferation in behavioral intervention development due to guidelines recommending their use for managing common, distressing, and interfering symptoms (e.g., insomnia, pain, fatigue) resulting from medical disease (e.g., cancer) and its treatment. Several models of behavioral intervention development exist (e.g., Stage Model, ORBIT). In this review, we focus on the National Institute of Health (NIH) Stage Model for Behavioral Intervention Development because it offers the closest analogue to the formalized drug development process. This review compares the phases of drug development to the six stages of the Stage Model for behavioral intervention development to assist investigators in understanding similarities and differences in terminology (i.e., Phase versus Stage), study designs and methods, and ultimate purpose. Distinguishing features of the NIH Stage Model for behavioral intervention development are highlighted and include: (1) a recursive and iterative flow; and (2) a focus on intervention mechanisms at every stage of development. To illustrate each stage, we refer to a program of research developing and testing a behavioral insomnia and symptom (e.g., pain, fatigue) management intervention for patients with life-threatening hematologic cancer. This illustrative example conveys the initial steps required to develop and pilot test a behavioral intervention before progressing to larger-scale efficacy and effectiveness testing. To conclude, we offer recommendations for investigators designing and testing behavioral interventions. Recommendations are first, develop a long-term research plan that begins with the end in mind, and second, ensure each step in the research plan provides sufficient information to proceed to the next stage.