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Keywords:

  • clinical trials;
  • behavioral therapies;
  • stage model;
  • study design;
  • methodology

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.