The progressively rigorous methodological requirements of conducting clinical trials of behavioral treatments has placed a large burden on individual investigators, as treatment manuals, methods of evaluating treatment quality and fidelity, and persuasive evidence of the treatment's promise are now virtual requirements of receiving support for conducting a clinical trial of a new or adapted treatment. A Stage Model of Behavioral Therapies research, by articulating the progressive stages of development and evaluation for behavioral treatments, recognizes the scientific merit and need for support for treatment development and initial evaluation designated as stage I. This article describes the conduct of stage I research, including issues addressed in stage I research, major design decisions confronted by investigators, the close relationship of stage I to stage II research and proposes a time line for stage I research.

Compared with professional psychotherapy, a manual-guided combination of intensive individual drug counseling and GDC has promise for the treatment of cocaine dependence.

We present a vision of clinical science, based on a conceptual framework of intervention development endorsed by the Delaware Project. This framework is grounded in an updated stage model that incorporates basic science questions of mechanisms into every stage of clinical science research. The vision presented is intended to unify various aspects of clinical science toward the common goal of developing maximally potent and implementable interventions, while unveiling new avenues of science in which basic and applied goals are of equally high importance. Training in this integrated, translational model may help students learn how to conduct research in every domain of clinical science and at each stage of intervention development. This vision aims to propel the field to fulfill the public health goal of producing implementable and effective treatment and prevention interventions.

The goal of the NIH Science of Behavior Change (SOBC) Common Fund Program is to provide the basis for an experimental medicine approach to behavior change that focuses on identifying and measuring the mechanisms that underlie behavioral patterns we are trying to change. This paper frames the development of the program within a discussion of the substantial disease burden in the U.S. attributable to behavioral factors, and details our strategies for breaking down the disease- and condition-focused silos in the behavior change field to accelerate discovery and translation. These principles serve as the foundation for our vision for a unified science of behavior change at the NIH and in the broader research community.