The microrandomized trial for developing digital interventions: Experimental design and data analysis considerations

Abstract

Just-in-time adaptive interventions (JITAIs) are time-varying adaptive interventions that use frequent opportunities for the intervention to be adapted-weekly, daily, or even many times a day. The microrandomized trial (MRT) has emerged for use in informing the construction of JITAIs. MRTs can be used to address research questions about whether and under what circumstances JITAI components are effective, with the ultimate objective of developing effective and efficient JITAI. The purpose of this article is to clarify why, when, and how to use MRTs; to highlight elements that must be considered when designing and implementing an MRT; and to review primary and secondary analyses methods for MRTs. We briefly review key elements of JITAIs and discuss a variety of considerations that go into planning and designing an MRT. We provide a definition of causal excursion effects suitable for use in primary and secondary analyses of MRT data to inform JITAI development. We review the weighted and centered least-squares (WCLS) estimator which provides consistent causal excursion effect estimators from MRT data. We describe how the WCLS estimator along with associated test statistics can be obtained using standard statistical software such as R (R Core Team, 2019). Throughout we illustrate the MRT design and analyses using the HeartSteps MRT, for developing a JITAI to increase physical activity among sedentary individuals. We supplement the HeartSteps MRT with two other MRTs, SARA and BariFit, each of which highlights different research questions that can be addressed using the MRT and experimental design considerations that might arise. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Figure 1.

A conceptual model for the two push components in HeartSteps: Activity Suggestions and Planning Support.

Figure 2.

Schematic of randomization for the Activity Suggestions component in the Heart Steps micro-randomized trial (MRT). In each of the 42 days of the experiment, at each prespecified time of randomization, t_m, where m = 1 to 5, an assessment was made of whether the intervention was disabled, or the participant was driving or walking. If any of these was “yes,” no randomization was performed. Otherwise, the individual was randomized to be shown a walking activity suggestion (p=.30), anti-sedentary suggestion (p=.30), or no suggestion (p=.40).