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Exclusion of Suicidal Participants From Randomized Controlled Trials for Posttraumatic Stress Disorder: A Meta-Analysis
Journal of Traumatic Stress ( IF 2.4 ) Pub Date : 2020-10-21 , DOI: 10.1002/jts.22610
Emily Brooks 1 , Megan Spokas 1 , Deborah Goldschmidt 1
Affiliation  

There has been a lack of consensus regarding whether to include or exclude participants with suicidal ideation (SI) from posttraumatic stress disorder (PTSD) psychotherapy clinical trials and, until recently, how best to report adverse events related to suicide risk. Without consistent reporting or evaluation of SI as an outcome, clinical practice guidelines are limited in their ability to recommend interventions for this common co-occurrence. In the present meta-analysis, we compared randomized controlled trials (RCTs) of PTSD psychotherapies, based on their suicide exclusion criteria. The databases PILOTS, PsycINFO, and PubMed were searched for RCTs of psychotherapy that lasted more than 4 weeks and included adults who met the diagnostic criteria for PTSD. Included studies (N = 48) were coded by two independent reviewers. A random-effects model was used to calculate the pooled effect sizes for trials that excluded (n = 31) and did not exclude SI (n = 17). A test statistic for the significance of effect revealed that the difference between these two groups’ effect sizes was not significant, z = 0.96, p = .341. This suggests that the effects observed in clinical trials are not significantly impacted by SI-related exclusion criteria.

中文翻译:

将有自杀倾向的参与者排除在创伤后应激障碍的随机对照试验之外:荟萃分析

关于是否在创伤后应激障碍 (PTSD) 心理治疗临床试验中包括或排除有自杀意念 (SI) 的参与者,以及如何最好地报告与自杀风险相关的不良事件,一直缺乏共识。如果没有对 SI 作为结果的一致报告或评估,临床实践指南在推荐针对这种常见共同发生的干预措施方面的能力有限。在目前的荟萃分析中,我们根据自杀排除标准比较了 PTSD 心理治疗的随机对照试验 (RCT)。在 PILOTS、PsycINFO 和 PubMed 数据库中搜索了持续超过 4 周的心理治疗 RCT,其中包括符合 PTSD 诊断标准的成年人。纳入研究(N= 48) 由两名独立评审员编码。随机效应模型用于计算排除 ( n = 31) 和不排除 SI ( n = 17) 的试验的汇总效应大小。效应显着性的检验统计表明,这两组效应大小之间的差异不显着,z = 0.96,p = .341。这表明临床试验中观察到的效果不受 SI 相关排除标准的显着影响。
更新日期:2020-10-21
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