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 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。本批判性综述总结了心理干预 AE 的定义、评估和当前研究现状。总结 AE 定义为在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 AE 可分为正确应用治疗的副作用、医疗事故（即错误应用的治疗）和不道德行为（例如性虐待）。理想情况下，它们由独立的评估者评估，或者通过自我报告问卷进行评估，这些问卷还应涵盖严重不良事件（SAE，例如自杀未遂或自残行为）。大约 1 至 2/3 的患者报告至少 1 次 AE，荟萃分析结果表明，治疗在 AE 的频率和/或严重程度以及治疗可接受性（以退出率衡量）方面可能有所不同。关键信息：AE 和 SAE 的测量以及更细致的辍学描述应包括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 AE、SAE 和可接受性方面有所不同。由于许多心理干预的效果大致相同，因此有一天可能会根据其安全性的差异而不是有效性的差异来选择它们。理想情况下，减少 AE 也可能带来更有效的干预措施。