![]() ![]() Among the many innovations and adaptations, psychological treatments were standardized through manualization, therapist training, supervision, and fidelity monitoring to maximize internal validity. Principle of intervention trial#To respond to early critiques that psychological interventions have little effect, rigorous methodology was developed, often using principles from pharmacological trial design, to evaluate psychological and behavioral interventions. Modern RCT methodologies in medicine were developed to evaluate pharmacological agents that are not intended or expected to be modified frequently. The Purpose of a Randomized Controlled Trial ![]() The purpose of this paper is to propose adaptations of traditional randomized controlled trial (RCT) methodology that can support evaluation of BITs. There have been increasing calls for methodologies that allow for continuous quality improvement through more rapid incorporation of changes and accumulating knowledge in the context of trials. Failing to meet changing user expectations relegates a BIT to increasing irrelevance to users. For example, social networking and peer-to-peer messaging is a common feature in many recently developed BITs due to the popularity of social networking tools such as Facebook, Twitter, etc. When developers of a BIT observe that a feature used in other apps has become popular, they often add similar functionality to respond to the expectations of their customer base. The expectations and culture of BIT users are rapidly changing. However, some changes alter the content and functionality and are intended to modify or improve the user’s experience and the benefit they receive.īITs change to harness affordances provided by the rapidly changing technological environment, such as improving computing power, leveraging new data capture and user interface functions, and growing capacity for data transmission. Many of these updates are bug fixes, operating system upgrades, or changes to support the emergence of new devices. As anyone who has installed an app knows, their life on a device evolves through a steady stream of updates. In practice, BITs change and evolve over time. The term BIT is used, rather than eHealth or mHealth, as these terms can reflect a much broader area of medicine and informatics not necessarily focused on behavior change. Mobile health apps, treatment and prevention websites, sensors used in activity trackers, and smartwatches are common examples. 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.īehavioral intervention technologies (BITs) employ technologies, such as mobile phones, tablets, computers, sensors, and other tools to support behavior change related to health, mental health, and wellness. 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. 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. 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. ![]() 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. 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. ![]()
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