Adherence
Behavioral treatments for chronic diseases must undergo a structured, iterative pre-efficacy development process (ORBIT model) involving Phase I (Design) and Phase II (Preliminary Testing) to ensure clinical significance before large-scale efficacy trials.
If you are developing a health behavior intervention, do not skip to large-scale testing. Use the ORBIT model: Start with Phase I (Design) to define the problem and basic elements, then Phase Ib (Refine) to optimize components and delivery. Only move to Phase II (Preliminary Testing) when you have a fixed protocol that shows clinically significant change in a small sample. This iterative process ensures your final large-scale trial has a real chance of success.
This article provides a systematic framework for developing behavioral treatments for preventing and treating chronic diseases... The ORBIT model for behavioral treatment development features a flexible and progressive process, prespecified clinically significant milestones for forward movement, and return to earlier stages for refinement and optimization.
Why this rating
This is a consensus framework paper from the NIH/ORBIT consortium, synthesizing expert opinion and prior research, representing the highest level of methodological guidance.
Source
From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases.
Susan M. Czajkowski et al. · Health Psychology · 2015
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