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.

心理健康应用程序是有效的，但它们可能会对某些应用程序构成风险。本综述 （CRD42024506486） 检查了心理健康应用程序的不良事件 （AE）。我们检索了（2024 年 5 月）Medline、PsycINFO、Web of Science 和 ProQuest 数据库，以确定心理健康应用程序的临床试验。使用 Cochrane 偏倚风险工具评估偏倚风险。在确定的 171 项临床试验中，只有 55 项报告了 AE。在对精神分裂症进行抽样和提供具有症状监测技术的应用程序的试验中，更有可能报告 AE。13 种应用条件的荟萃分析恶化率为 6.7% （95% CI = 4.3， 10.1， I² = 75%）。应用组和对照组之间的恶化率没有差异 （OR = 0.79,95% CI = 0.62–1.01，I ² = 0%）。AE 的报告在使用的评估、记录的事件和提供的详细信息方面是异质的。总体而言，很少有心理健康应用程序的临床试验报告 AE。那些提供这些信息的 API 通常提供的信息不足，无法正确判断与应用程序使用相关的风险。