Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Exclusion of Participants with Suicidal Thoughts and Behaviors in Digital Therapy Trials from 2005-2024: A Scoping Review
ABSTRACT
Background:
Digital mental health interventions (DMHIs) have gained recognition as accessible alternatives to traditional in-person mental health care. Randomized controlled trials (RCTs) evaluating DMHIs frequently exclude individuals with suicidal thoughts and behavior (STB). Yet, little is known about how such exclusions are operationalized or how these practices have changed over time.
Objective:
This review aimed to characterize how RCTs of DMHIs for depression, anxiety, and related disorders have excluded participants for STB over the last two decades (2005 - 2024).
Methods:
A systematic search identified RCTs evaluating CBT-based DMHIs published between 2005 and 2024. Trials were coded for whether and how they excluded participants with STB, including the assessment measures and cutoff thresholds used. Chi-square and Fisher's exact tests were used to estimate differences across decades and target disorder categories. We registered our protocol prospectively in the Open Science Framework (OSF): https://osf.io/sm8xa.
Results:
212 eligible RCTs were included. Studies were significantly more likely to exclude for STB than not (n = 163 [76.9%] vs. n = 49 [23.1%]; p <.001). Among the 163 studies excluding for STB, 53% (n = 88) did not report the number of participants excluded for STB and relatively few reported the specific assessment measure and threshold used to exclude (n = 63/163, 38.7% reporting vs n = 100/163, 61.3% not reporting; p < .01). Among the studies that reported a measure, many used the Patient Health Questionnaire-9 (PHQ-9; 30%, n = 49/163). Exclusion rates were comparable across the past two decades (n = 48/60, 80% vs n = 115/153, p =.45). The rate of exclusion did not differ by DMHI target disorder (χ²= 2.33(df) = 2; adj. p = .37), but the proportion of studies not reporting the measure used to exclude for STB increased significantly from 2005–2014 (n = 4/48, 8.3%) to 2015–2024 (n = 28/115, 24.3%; OR = 3.52, p < .05).
Conclusions:
Most DMHI trials for depression, anxiety, and related disorders exclude participants with STB, yet reporting on these exclusions is inconsistent and potentially worsening. We propose a preliminary framework—SAFE—to guide screening practices, the operationalization of inclusion and exclusion thresholds, and transparent reporting of STB-related eligibility criteria in DMHI RCTs. The SAFE framework outlines four key components: (1) Screen with validated suicide-specific measures in addition to depression symptom scales, (2) Assess risk regularly at multiple timepoints, (3) Formalize and justify exclusion thresholds a priori, and (4) Ensure transparent reporting of assessment measures and thresholds. Establishing such guidelines for assessing and reporting STB exclusions could improve reproducibility, equity, and the safe inclusion of individuals who may benefit from digital interventions.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.