npj Digital Medicine (Sep 2023)

Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology

  • Simon B. Goldberg,
  • Shufang Sun,
  • Per Carlbring,
  • John Torous

DOI
https://doi.org/10.1038/s41746-023-00923-7
Journal volume & issue
Vol. 6, no. 1
pp. 1 – 8

Abstract

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Abstract Hundreds of randomized controlled trials (RCTs) have tested the efficacy of mobile health (mHealth) tools for a wide range of mental and behavioral health outcomes. These RCTs have used a variety of control condition types which dramatically influence the scientific inferences that can be drawn from a given study. Unfortunately, nomenclature across mHealth RCTs is inconsistent and meta-analyses commonly combine control conditions that differ in potentially important ways. We propose a typology of control condition types in mHealth RCTs. We define 11 control condition types, discuss key dimensions on which they differ, provide a decision tree for selecting and identifying types, and describe the scientific inferences each comparison allows. We propose a five-tier comparison strength gradation along with four simplified categorization schemes. Lastly, we discuss unresolved definitional, ethical, and meta-analytic issues related to the categorization of control conditions in mHealth RCTs.