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<p>Clinical trials in digital mental health have grown rapidly, yet little research has examined their informativeness. This study assessed the proportions of recent trials that met indicators of informativeness and explored related factors. Using stratified sampling from five trial registries, we randomly selected 25% (<i>N</i> = 152) of recent trials for depression, anxiety, and psychosis in high-income and low- and middle-income countries. Each trial was evaluated against 17 established indicators. On average, trials met only half of these (<i>M</i> = 8.9, SD = 4.57, range 2–17). Just 5.3% (<i>n</i> = 8) met all indicators, with methodological criteria more often satisfied than those related to ethical, equitable, or open research practices. Informativeness did not differ by disorder or region but was higher where trial documentation and reporting were more accessible, with notable variation across registries. Findings highlight that many digital mental health trials may lack value for stakeholders, underscoring the need to prioritise informativeness and improve registry reporting.</p>

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An assessment of the informativeness of clinical trials in digital mental health

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年12月17日

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  • Bridianne O’Dea,
  • Sally Rooke,
  • Eliza-Rose Gordon,
  • Fergus L. Lyons,
  • Bojana Vilus,
  • Neelesh Paravastu,
  • Philip J. Batterham

摘要

Clinical trials in digital mental health have grown rapidly, yet little research has examined their informativeness. This study assessed the proportions of recent trials that met indicators of informativeness and explored related factors. Using stratified sampling from five trial registries, we randomly selected 25% (N = 152) of recent trials for depression, anxiety, and psychosis in high-income and low- and middle-income countries. Each trial was evaluated against 17 established indicators. On average, trials met only half of these (M = 8.9, SD = 4.57, range 2–17). Just 5.3% (n = 8) met all indicators, with methodological criteria more often satisfied than those related to ethical, equitable, or open research practices. Informativeness did not differ by disorder or region but was higher where trial documentation and reporting were more accessible, with notable variation across registries. Findings highlight that many digital mental health trials may lack value for stakeholders, underscoring the need to prioritise informativeness and improve registry reporting.