title: Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies.
abstract: In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.
authors.affiliation: Center for Behavioral Intervention Technologies (CBITs), Northwestern University, Chicago, IL, United States. d-mohr@northwestern.edu.
authors.forename: David C
authors.identifier: http://orcid.org/0000-0002-5443-7596
authors.initials: DC
authors.lastname: Mohr
authors.forename: Stephen M
authors.identifier: http://orcid.org/0000-0002-1003-0399
authors.initials: SM
authors.lastname: Schueller
authors.forename: William T
authors.identifier: http://orcid.org/0000-0001-5366-7464
authors.initials: WT
authors.lastname: Riley
authors.forename: C Hendricks
authors.identifier: http://orcid.org/0000-0002-0294-2419
authors.initials: CH
authors.lastname: Brown
authors.forename: Pim
authors.identifier: http://orcid.org/0000-0001-5497-2743
authors.initials: P
authors.lastname: Cuijpers
authors.forename: Naihua
authors.identifier: http://orcid.org/0000-0001-9411-2924
authors.initials: N
authors.lastname: Duan
authors.forename: Mary J
authors.identifier: http://orcid.org/0000-0003-3287-1903
authors.initials: MJ
authors.lastname: Kwasny
authors.forename: Colleen
authors.identifier: http://orcid.org/0000-0002-6759-8380
authors.initials: C
authors.lastname: Stiles-Shields
authors.forename: Ken
authors.identifier: http://orcid.org/0000-0001-5199-0102
authors.initials: K
authors.lastname: Cheung
mesh_terms: D001521:Behavior Therapy / Q000379:methods* / Q000592:standards; D006801:Humans; D008490:Medical Informatics / Q000379:methods* / Q000592:standards; D058996:Quality Improvement; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D017216:Telemedicine
keywords: clinical trials; eHealth; mHealth; methodology