Systematic review and meta-analysis of adverse events in clinical trials of mental health apps
Open accessAbstract
Mental health apps are efficacious, yet they may pose risks in some. This review (CRD42024506486) examined adverse events (AEs) from mental health apps. We searched (May 2024) the Medline, PsycINFO, Web of Science, and ProQuest databases to identify clinical trials of mental health apps. The risk of bias was assessed using the Cochrane Risk of Bias tool. Only 55 of 171 identified clinical trials reported AEs. AEs were more likely to be reported in trials sampling schizophrenia and delivering apps with symptom monitoring technology. The meta-analytic deterioration rate from 13 app conditions was 6.7% (95% CI = 4.3, 10.1, I 2 = 75%). Deterioration rates did not differ between app and control groups (OR = 0.79, 95% CI = 0.62–1.01, I 2 = 0%). Reporting of AEs was heterogeneous, in terms of assessments used, events recorded, and detail provided. Overall, few clinical trials of mental health apps report AEs. Those that do often provide insufficient information to properly judge risks related to app use.
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Self-citation
- Authors
- Linardon, J., Fuller-Tyszkiewicz, M., Firth, J., Goldberg, S. B., Anderson, C., McClure, Z., & Torous, J.
- Affiliations
- Deakin University (AU)
- Greater Manchester Mental Health NHS Foundation Trust (GB)
- University of Wisconsin–Madison (US)
- Beth Israel Deaconess Medical Center (US)
- Corresponding author
- Linardon, Jake
- Venue
- npj Digital Medicine
- Published
- 2024-12-18
- Volume
- 7
- Issue
- 1
- Pages
- 363-363
- ISSN
- 2398-6352 (ISSN-L)
- PMC
- PMC11655657
- OpenAlex
- W4405516678
- Cited by
- 44
- References
- 60
- Citations by year
- 2026: 18 · 2025: 26
- FWCI
- 2.31
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- npj Digital Medicine (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Figshare (submittedVersion, cc-by-nc-nd)
- Funders
- Argosy Foundation
- UK Research and Innovation (MR/T021780/1)
- National Institutes of Health
- Medical Research Council (MR/T021780/1)
- National Health and Medical Research Council (1196948, K23AT010879)
- National Center for Complementary and Integrative Health (K23AT010879, R24AT012845)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Mental Health Research Topics
- Keywords
- mental health apps, adverse events, digital mental health interventions, clinical trials, schizophrenia, symptom monitoring, degradation rate, risk of bias, adverse event reporting, mobile application security
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