Bates Andrew, Golding Hannah, Rushbrook Sophie, Shapiro Elan, Pattison Natalie, Baldwin David S, Grocott Michael P W, Cusack Rebecca
NIHR Southampton Biomedical Research Centre, University Hospitals Southampton National Health Service Foundation Trust, Southampton, UK.
Faculty of Medicine, University of Southampton, Southampton, UK.
J Intensive Care Soc. 2023 Aug;24(3):309-319. doi: 10.1177/17511437221136828. Epub 2022 Nov 19.
Approximately 50% of intensive care survivors experience persistent psychological symptoms. Eye-movement desensitisation and reprocessing (EMDR) is a widely recommended trauma-focussed psychological therapy, which has not been investigated systematically in a cohort of intensive care survivors: We therefore conducted a randomised pilot feasibility study of EMDR, using the Recent Traumatic Episode Protocol (R-TEP), to prevent psychological distress in intensive care survivors. Findings will determine whether it would be possible to conduct a fully-powered clinical effectiveness trial and inform trial design.
We aimed to recruit 26 patients who had been admitted to intensive care for over 24 h with COVID-19 infection. Consenting participants were randomised (1:1) to receive either usual care plus remotely delivered EMDR R-TEP or usual care alone (controls). The primary outcome was feasibility. We also report factors related to safety and symptom changes in post-traumatic stress disorder, (PTSD) anxiety and depression.
We approached 51 eligible patients, with 26 (51%) providing consent. Intervention adherence (sessions offered/sessions completed) was 83%, and 23/26 participants completed all study procedures. There were no attributable adverse events. Between baseline and 6-month follow-up, mean change in PTSD score was -8 (SD = 10.5) in the intervention group versus +0.75 (SD = 15.2) in controls ( = 0.126). There were no significant changes to anxiety or depression.
Remotely delivered EMDR R-TEP met pre-determined feasibility and safety objectives. Whilst we achieved group separation in PTSD symptom change, we have identified a number of protocol refinements that would improve the design of a fully powered, multi-centre randomised controlled trial, consistent with currently recommended rehabilitation clinical pathways.
ClinicalTrials.gov: NCT04455360.
约50%的重症监护幸存者会出现持续的心理症状。眼动脱敏再处理疗法（EMDR）是一种广泛推荐的针对创伤的心理治疗方法，但尚未在重症监护幸存者队列中进行系统研究。因此，我们采用近期创伤事件方案（R-TEP）对EMDR进行了一项随机试点可行性研究，以预防重症监护幸存者的心理困扰。研究结果将确定是否有可能开展一项充分有力的临床疗效试验，并为试验设计提供信息。
我们旨在招募26名因新冠病毒感染入住重症监护病房超过24小时的患者。同意参与的参与者被随机分为两组（1:1），分别接受常规护理加远程提供的EMDR R-TEP或仅接受常规护理（对照组）。主要结局指标是可行性。我们还报告了与创伤后应激障碍（PTSD）、焦虑和抑郁的安全性及症状变化相关的因素。
我们接触了51名符合条件的患者，其中26名（51%）给予了同意。干预依从性（提供的疗程数/完成的疗程数）为83%，23/26名参与者完成了所有研究程序。没有可归因的不良事件。在基线和6个月随访之间，干预组PTSD评分的平均变化为-8（标准差=10.5），而对照组为+0.75（标准差=15.2）（P=0.126）。焦虑或抑郁没有显著变化。
远程提供的EMDR R-TEP达到了预先确定的可行性和安全性目标。虽然我们在PTSD症状变化方面实现了组间分离，但我们已经确定了一些方案改进措施，这些措施将改进一项充分有力的多中心随机对照试验的设计，与目前推荐的康复临床路径一致。
ClinicalTrials.gov：NCT04455360。
