一项关于眼动脱敏与再处理近期创伤事件方案的随机试点可行性研究，以改善因新冠肺炎入住重症监护病房后的心理恢复情况。
A randomised pilot feasibility study of eye movement desensitisation and reprocessing recent traumatic episode protocol, to improve psychological recovery following intensive care admission for COVID-19.
作者信息
Bates Andrew, Golding Hannah, Rushbrook Sophie, Shapiro Elan, Pattison Natalie, Baldwin David S, Grocott Michael P W, Cusack Rebecca
机构信息
NIHR Southampton Biomedical Research Centre, University Hospitals Southampton National Health Service Foundation Trust, Southampton, UK.
Faculty of Medicine, University of Southampton, Southampton, UK.
出版信息
J Intensive Care Soc. 2023 Aug;24(3):309-319. doi: 10.1177/17511437221136828. Epub 2022 Nov 19.
BACKGROUND
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.
METHOD
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.
RESULTS
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.
CONCLUSION
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.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT04455360.
背景
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。
方法
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。
结果
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。
结论
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。
试验注册
ClinicalTrials.gov：NCT04455360。
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