Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Department of Neuroscience, Psychiatry, National Centre for Disaster Psychiatry, Uppsala, Sweden.
PLoS One. 2021 May 24;16(5):e0251898. doi: 10.1371/journal.pone.0251898. eCollection 2021.
The main purpose of the current trial was to test if a brief trauma-focused cognitive-behaviour therapy protocol (prolonged exposure; PE) provided within 72 h after a traumatic event could be effective in decreasing the incidence of post-traumatic stress disorder (PTSD), thus replicating and extending the findings from an earlier trial. After a pilot study (N = 10), which indicated feasible and deliverable study procedures and interventions, we launched an RCT with a target sample size of 352 participants randomised to either three sessions of PE or non-directive support. Due to an unforeseen major reorganisation at the hospital, the RCT was discontinued after 32 included participants. In this paper, we highlight obstacles and lessons learned from our feasibility work that are relevant for preventive psychological interventions for PTSD in emergency settings. One important finding was the high degree of attrition, and only 75% and 34%, respectively, came back for the 2-month and 6-month assessments. There were also difficulties in reaching eligible patients immediately after the event. Based on our experiences, we envisage that alternative models of implementation might overcome these obstacles, for example, with remote delivery of both assessments and interventions via the internet or smartphones combined with multiple recruitment procedures. Lessons learned from this terminated RCT are discussed in depth.
本研究的主要目的是验证创伤后即刻(72 小时内)开展短程聚焦创伤认知行为疗法(延长暴露疗法;PE)是否能有效降低创伤后应激障碍(PTSD)的发生率,从而复制和扩展早期试验的结果。在一项试点研究(N=10)后,我们确定了可行和可实施的研究程序和干预措施,随后开展了一项 RCT,共有 352 名参与者被随机分为三组,分别接受 3 次 PE 或非指导性支持。由于医院发生了一次意外的重大重组,该 RCT 在纳入 32 名参与者后停止。在本文中,我们重点介绍了在可行性工作中遇到的障碍和经验教训,这些对于在紧急情况下对 PTSD 进行预防性心理干预具有重要意义。一个重要的发现是高脱落率,分别只有 75%和 34%的参与者回来参加了 2 个月和 6 个月的评估。此外,在事件发生后立即接触到符合条件的患者也存在困难。基于我们的经验,我们设想可以通过其他实施模式来克服这些障碍,例如通过互联网或智能手机远程提供评估和干预,同时结合多种招募程序。本文深入讨论了从这项终止的 RCT 中吸取的经验教训。