Andrew Bates, Hannah Golding, Sophie Rushbrook, Elan Shapiro, Natalie Pattison, David S Baldwin, Michael P W Grocott, Rebecca Cusack
{"title":"一项关于眼球运动脱敏和再处理最近创伤性发作方案的随机试点可行性研究,以改善新冠肺炎重症监护入院后的心理恢复。","authors":"Andrew Bates, Hannah Golding, Sophie Rushbrook, Elan Shapiro, Natalie Pattison, David S Baldwin, Michael P W Grocott, Rebecca Cusack","doi":"10.1177/17511437221136828","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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 (<i>p</i> = 0.126). There were no significant changes to anxiety or depression.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT04455360.</p>","PeriodicalId":39161,"journal":{"name":"Journal of the Intensive Care Society","volume":"24 3","pages":"309-319"},"PeriodicalIF":2.1000,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9679313/pdf/10.1177_17511437221136828.pdf","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Andrew Bates, Hannah Golding, Sophie Rushbrook, Elan Shapiro, Natalie Pattison, David S Baldwin, Michael P W Grocott, Rebecca Cusack\",\"doi\":\"10.1177/17511437221136828\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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 (<i>p</i> = 0.126). There were no significant changes to anxiety or depression.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT04455360.</p>\",\"PeriodicalId\":39161,\"journal\":{\"name\":\"Journal of the Intensive Care Society\",\"volume\":\"24 3\",\"pages\":\"309-319\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2023-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9679313/pdf/10.1177_17511437221136828.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the Intensive Care Society\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/17511437221136828\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/11/19 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"CRITICAL CARE MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the Intensive Care Society","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/17511437221136828","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/11/19 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}
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.
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 (p = 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.
期刊介绍:
The Journal of the Intensive Care Society (JICS) is an international, peer-reviewed journal that strives to disseminate clinically and scientifically relevant peer-reviewed research, evaluation, experience and opinion to all staff working in the field of intensive care medicine. Our aim is to inform clinicians on the provision of best practice and provide direction for innovative scientific research in what is one of the broadest and most multi-disciplinary healthcare specialties. While original articles and systematic reviews lie at the heart of the Journal, we also value and recognise the need for opinion articles, case reports and correspondence to guide clinically and scientifically important areas in which conclusive evidence is lacking. The style of the Journal is based on its founding mission statement to ‘instruct, inform and entertain by encompassing the best aspects of both tabloid and broadsheet''.