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How are adverse events identified and categorised in trials of digital mental health interventions? A narrative scoping review of trials in the ISRCTN registry

Bergin, Aislinn D. Gómez; Valentine, Althea Z.; Rennick Egglestone, Stefan; Slade, Mike; Hollis, Chris; Hall, Charlotte L.


Professor of Mental Health Recovery and Social Inclusion

Professor of Child and Adolescent Psychiatry and Digital Mental Health


Background: To contextualize the benefits of an intervention, it is important that adverse events (AEs) are reported. This is potentially difficult in trials of digital mental health interventions, where delivery may be remote and the mechanisms of actions less understood.

Objective: We aimed to explore the reporting of AEs in randomized controlled trials of digital mental health interventions.

Methods: The International Standard Randomized Controlled Trial Number database was searched for trials registered before May 2022. Using advanced search filters, we identified 2546 trials in the category of mental and behavioral disorders. These trials were independently reviewed by 2 researchers against the eligibility criteria. Trials were included where digital mental health interventions for participants with a mental health disorder were evaluated through a completed randomized controlled trial (protocol and primary results publication published). Published protocols and primary results publications were then retrieved. Data were extracted independently by 3 researchers, with discussion to reach consensus when required.

Results: Twenty-three trials met the eligibility criteria, of which 16 (69%) included a statement on AEs within a publication, but only 6 (26%) reported AEs within their primary results publication. Seriousness was referred to by 6 trials, relatedness by 4, and expectedness by 2. More interventions delivered with human support (9/11, 82%) than those with only remote or no support (6/12, 50%) included a statement on AEs, but they did not report more AEs. Several reasons for participant dropout were identified by trials that did not report AEs, of which some were identifiable or related to AEs, including serious AEs.

Conclusions: There is significant variation in the reporting of AEs in trials of digital mental health interventions. This variation may reflect limited reporting processes and difficulty recognizing AEs related to digital mental health interventions. There is a need to develop guidelines specifically for these trials to improve future reporting.


Bergin, A. D. G., Valentine, A. Z., Rennick Egglestone, S., Slade, M., Hollis, C., & Hall, C. L. (2023). How are adverse events identified and categorised in trials of digital mental health interventions? A narrative scoping review of trials in the ISRCTN registry. JMIR Mental Health, 10, Article e42501.

Journal Article Type Article
Acceptance Date Dec 10, 2022
Online Publication Date Feb 22, 2023
Publication Date 2023
Deposit Date Dec 12, 2022
Publicly Available Date Feb 22, 2023
Journal JMIR Mental Health
Electronic ISSN 2368-7959
Publisher JMIR Publications
Peer Reviewed Peer Reviewed
Volume 10
Article Number e42501
Public URL
Publisher URL


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