TY - JOUR
T1 - Systematic review and meta-analysis of adverse events in clinical trials of mental health apps
AU - Linardon, Jake
AU - Fuller-Tyszkiewicz, Matthew
AU - Firth, Joseph
AU - Goldberg, Simon B.
AU - Anderson, Cleo
AU - McClure, Zoe
AU - Torous, John
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/12
Y1 - 2024/12
N2 - 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, I2 = 75%). Deterioration rates did not differ between app and control groups (OR = 0.79, 95% CI = 0.62-1.01, I2 = 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.
AB - 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, I2 = 75%). Deterioration rates did not differ between app and control groups (OR = 0.79, 95% CI = 0.62-1.01, I2 = 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.
UR - http://www.scopus.com/inward/record.url?scp=85212446680&partnerID=8YFLogxK
U2 - 10.1038/s41746-024-01388-y
DO - 10.1038/s41746-024-01388-y
M3 - Article
AN - SCOPUS:85212446680
SN - 2398-6352
VL - 7
JO - npj Digital Medicine
JF - npj Digital Medicine
IS - 1
M1 - 363
ER -