心理治疗随机对照试验中的不良事件：系统评价

Adverse events in psychotherapy randomized controlled trials: A systematic review

《心理治疗研究》2025年，第35卷，第1期

<Psychotherapy Research> Volume 35, Issue 1, 2025

      【摘要】目的：尽管有大量证据表明心理治疗有益，但人们对其潜在危害知之甚少。因此，我们系统地总结了随机对照试验 (RCT)，以汇编心理治疗不良事件 (AE) 发生频率和特征的循证数据。方法：本系统综述基于对心理治疗研究方案中危害考虑的综述，对结果出版物进行了系统评价。结果：根据 115 项研究方案，85 项 RCT（包括 126 种心理治疗和 61 种对照条件）符合纳入标准。样本包括 14,420 名患有最常见精神障碍的参与者。60% 的研究明确报告了有害事件，例如不良事件、症状恶化的人数。不良事件的概念化、记录和报告各不相同。对于大多数报告的不良事件，与研究治疗的关联仍不清楚。结论：由于各个研究的不良事件记录方法有很大差异，因此只能在有限的范围内比较结果。与其他研究结果一致，本综述表明，不良事件预计会影响十分之一以上的参与者。在心理治疗 RCT 中，超过 21 名参与者中就有一人发生严重不良事件。为了对心理治疗进行平衡的风险/收益评估，系统的危害监测和报告应成为心理治疗 RCT 的标准。

      【关键词】不良事件，危害，心理治疗，随机对照试验，系统评价

       [Abstract] Objective: Although evidence for benefits of psychotherapy is substantial, less is known about potential harm. Therefore, we systematically summarized randomized controlled trials (RCTs) to compile evidence-based data on the frequency and characteristics of adverse events (AEs) of psychotherapy. Method: This systematic review of result publications is based on a review of harm consideration in psychotherapy study protocols. Results: On the basis of 115 study protocols, 85 RCTs with 126 psychotherapy and 61 control conditions were eligible for inclusion. The sample consisted of 14,420 participants with the most common mental disorders. Harmful events, e.g., AEs, number of individuals with symptom deterioration, were explicitly reported in 60% of the studies. Conceptualization, recording, and reporting of AEs were heterogeneous. For most reported AEs, the association to study treatment remained unclear. Conclusions: Because the AE recording approaches of the individual studies differed substantially, results could only be compared to a limited extent. Consistent with other findings, this review demonstrates that AEs can be expected to affect more than one in ten participants. Serious AEs occurred more than in one in 21 participants in psychotherapy RCTs. To allow a balanced risk/benefit evaluation of psychotherapy, systematic harm monitoring and reporting should become standard in psychotherapy RCTs.

       [Key words] adverse events, harm, psychotherapy, RCT, systematic review

       论文原文：Rahel Klatte, Bernhard Strauss, Christoph Flückiger & Jenny Rosendah (2025).  events in psychotherapy randomized controlled trials: A systematic review. Psychotherapy Research, Volume 35, Issue 1, Pages 84-99.

https://doi.org/10.1080/10503307.2023.2286992

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