Klatte Rahel, Strauss Bernhard, Flückiger Christoph, Färber Francesca, Rosendahl Jenny
Institute of Psychosocial Medicine, Psychotherapy and Psychooncology, Jena University Hospital, Friedrich Schiller University Jena.
Department of Psychology, University of Zurich.
Psychotherapy (Chic). 2023 Mar;60(1):130-148. doi: 10.1037/pst0000359. Epub 2022 Jan 20.
The assessment of safety data has become a standard across many clinical interventions. The aim of this systematic review is to investigate the extent to which harm is addressed within psychotherapy study protocols. The review includes study protocols of randomized controlled trials published between 2004 and 2017 investigating the effects of psychotherapy in adult patients with affective disorders, phobia, anxiety, obsessive-compulsive disorder, posttraumatic stress disorder, and/or personality disorders. We conducted a systematic search in the CENTRAL, Medline, PsycINFO, and Web of Science databases as well as in relevant journals. In total, 115 study protocols were included, examining 168 psychotherapy and 85 control conditions. These protocols differed considerably in the way they conceptualized harm: 77 explicitly addressed harm, 62 considered serious adverse events, and 39 considered adverse events. Although serious adverse events were defined somewhat consistently, adverse events were not. Our results imply that clinical researchers do not apply standardized approaches with regard to harm concepts, assessment, and management. To gather data on frequencies of harmful effects, we argue a higher degree of standardization would be useful. Feasible recommendations are provided based on examples of good practice from the reviewed study protocols. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
对安全数据的评估已成为许多临床干预措施的一项标准。本系统评价的目的是调查心理治疗研究方案中对伤害问题的处理程度。该评价纳入了2004年至2017年间发表的随机对照试验的研究方案，这些试验调查了心理治疗对患有情感障碍、恐惧症、焦虑症、强迫症、创伤后应激障碍和/或人格障碍的成年患者的影响。我们在CENTRAL、Medline、PsycINFO和科学网数据库以及相关期刊中进行了系统检索。总共纳入了115项研究方案，考察了168种心理治疗和85种对照情况。这些方案在对伤害的概念化方式上有很大差异：77项明确涉及伤害，62项考虑了严重不良事件，39项考虑了不良事件。虽然严重不良事件的定义在一定程度上较为一致，但不良事件的定义并非如此。我们的结果表明，临床研究人员在伤害概念、评估和管理方面没有采用标准化方法。为了收集有害影响的发生频率数据，我们认为更高程度的标准化将是有用的。基于所审查研究方案中的良好实践示例提供了可行的建议。（PsycInfo数据库记录（c）2023美国心理学会，保留所有权利）
