Similarities and important distinctions between drug and behavioral intervention development.

Discover psychology Pub Date : 2025-01-01 Epub Date: 2025-04-22 DOI:10.1007/s44202-025-00352-5
Hannah M Fisher, Joseph G Winger, Gregory P Samsa, Tamara J Somers
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Abstract

There has been a proliferation in behavioral intervention development due to guidelines recommending their use for managing common, distressing, and interfering symptoms (e.g., insomnia, pain, fatigue) resulting from medical disease (e.g., cancer) and its treatment. Several models of behavioral intervention development exist (e.g., Stage Model, ORBIT). In this review, we focus on the National Institute of Health (NIH) Stage Model for Behavioral Intervention Development because it offers the closest analogue to the formalized drug development process. This review compares the phases of drug development to the six stages of the Stage Model for behavioral intervention development to assist investigators in understanding similarities and differences in terminology (i.e., Phase versus Stage), study designs and methods, and ultimate purpose. Distinguishing features of the NIH Stage Model for behavioral intervention development are highlighted and include: (1) a recursive and iterative flow; and (2) a focus on intervention mechanisms at every stage of development. To illustrate each stage, we refer to a program of research developing and testing a behavioral insomnia and symptom (e.g., pain, fatigue) management intervention for patients with life-threatening hematologic cancer. This illustrative example conveys the initial steps required to develop and pilot test a behavioral intervention before progressing to larger-scale efficacy and effectiveness testing. To conclude, we offer recommendations for investigators designing and testing behavioral interventions. Recommendations are first, develop a long-term research plan that begins with the end in mind, and second, ensure each step in the research plan provides sufficient information to proceed to the next stage.

药物和行为干预发展的相似之处和重要区别。
由于指导方针建议将行为干预用于管理医学疾病(如癌症)及其治疗引起的常见、令人痛苦和干扰性症状(如失眠、疼痛、疲劳),因此行为干预发展迅速。存在几种行为干预发展模型(例如,阶段模型,ORBIT)。在这篇综述中,我们将重点放在美国国立卫生研究院(NIH)行为干预发展阶段模型上,因为它提供了最接近正式药物开发过程的模拟。本文将药物开发阶段与行为干预发展阶段模型的六个阶段进行比较,以帮助研究者理解术语(即阶段与阶段)、研究设计和方法以及最终目的的异同。强调了NIH行为干预发展阶段模型的显著特征,包括:(1)递归迭代流程;(2)关注各发展阶段的干预机制。为了说明每个阶段,我们参考了一个研究项目,该项目开发和测试了对危及生命的血液学癌症患者的行为性失眠和症状(如疼痛、疲劳)管理干预。这个说明性的例子说明了在进行更大规模的功效和有效性测试之前,开发和试点测试行为干预所需的初始步骤。最后,我们为研究者设计和测试行为干预提供了建议。建议是,首先,制定一个长期的研究计划,以结束为开始,其次,确保研究计划的每一步都提供足够的信息,以进行下一阶段。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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