BACKGROUND The effectiveness of psychological interventions is undisputed. But while in other fields of health care the safety of interventions is studied alongside effectiveness, adverse events (AEs) have only recently been assessed in clinical studies of psychological interventions. This critical review summarizes the definition, assessment and current research status of AEs of psychological interventions. SUMMARY AEs are defined as any untoward event or unfavorable change that occurs in the course of a psychological intervention. AEs that are caused by the intervention can be classified into side effects of correctly applied treatment, malpractice (i.e., incorrectly applied treatment) and unethical conduct (e.g., sexual abuse). Ideally, they are assessed by independent raters or alternatively by self-report questionnaires that should also cover serious adverse events (SAEs, e.g., suicide attempts or self-injurious behaviors). About 1 to 2 in 3 patients report at least 1 AE and results of meta-analyses suggest that treatments might differ in frequency and/or severity of AE and in treatment acceptability (measured as dropout rates). KEY MESSAGES Measures of AEs and SAEs as well as more nuanced descriptions of dropout should be included in all clinical studies of psychological interventions. If this happens, we might learn that psychological interventions differ with respect to AEs, SAEs and acceptability. As many psychological interventions are about equally effective, they might one day be chosen based on differences in their safety profile rather than their differential effectiveness. Ideally, reducing AEs might also lead to more effective interventions.

中文翻译：

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心理干预的不良事件：定义、评估、研究现状以及对研究和临床实践的影响。


背景技术心理干预的有效性是无可争议的。但是，虽然在其他医疗保健领域，干预措施的安全性与有效性一起进行了研究，但不良事件 (AE) 直到最近才在心理干预的临床研究中进行评估。这篇评论总结了心理干预不良事件的定义、评估和当前研究现状。摘要 AE 被定义为心理干预过程中发生的任何不良事件或不利变化。由干预引起的不良事件可分为正确应用治疗的副作用、医疗事故（即不正确地应用治疗）和不道德行为（例如性虐待）。理想情况下，它们由独立评估者或通过自我报告问卷进行评估，其中还应涵盖严重不良事件（SAE，例如自杀未遂或自残行为）。大约三分之二的患者报告至少 1 次 AE，荟萃分析结果表明，治疗可能在 AE 的频率和/或严重程度以及治疗可接受性（以退出率衡量）方面有所不同。关键信息 AE 和 SAE 的测量以及对辍学的更细致的描述应包含在所有心理干预的临床研究中。如果发生这种情况，我们可能会了解到心理干预在不良事件、严重不良事件和可接受性方面有所不同。由于许多心理干预措施的效果大致相同，因此有一天可能会根据其安全性的差异而不是其有效性的差异来选择它们。理想情况下，减少不良事件也可能导致更有效的干预措施。