Similarities and important distinctions between drug and behavioral intervention development

Area of Science:

• Behavioral science
• Intervention development
• Health services research

Background:

• Behavioral interventions are increasingly recommended for managing distressing symptoms like insomnia, pain, and fatigue in patients with cancer.
• Existing models for behavioral intervention development include the Stage Model and ORBIT.

Purpose of the Study:

• To compare the National Institute of Health (NIH) Stage Model for Behavioral Intervention Development with the drug development process.
• To assist investigators in understanding the similarities and differences in terminology, study designs, methods, and purpose between behavioral intervention and drug development.
• To highlight distinguishing features of the NIH Stage Model, such as its recursive flow and focus on intervention mechanisms.

Main Methods:

• Review and comparison of the phases of drug development with the six stages of the NIH Stage Model.
• Illustration of each stage using a program of research for a behavioral insomnia and symptom management intervention for hematologic cancer patients.

Main Results:

• The NIH Stage Model provides a framework analogous to drug development, with distinct stages and a focus on iterative refinement.
• Key features include a recursive and iterative flow and emphasis on intervention mechanisms throughout development.
• An example demonstrates the initial steps of developing and pilot testing an intervention before efficacy trials.

Conclusions:

• Investigators should adopt a long-term research plan for behavioral interventions, starting with the end goal in mind.
• Each research step must yield sufficient data to justify progression to the subsequent stage.
• The NIH Stage Model offers a structured approach to developing and testing behavioral interventions for symptom management.