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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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Novel Apparatus and Method for Drug Reinforcement
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Similarities and important distinctions between drug and behavioral intervention development.

Hannah M Fisher1,2,3, Joseph G Winger1,2, Gregory P Samsa2,4

  • 1Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC USA.

Discover Psychology
|April 25, 2025
PubMed
Summary

Behavioral intervention development, like drug development, follows a structured process. The National Institute of Health (NIH) Stage Model guides researchers in creating effective interventions for symptom management in patients with cancer.

Keywords:
Behavioral intervention developmentBehavioral symptom managementDrug developmentHematologic cancerInsomniaStage model

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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.