Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK
Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
BMJ Open. 2024 Jan 29;14(1):e081969. doi: 10.1136/bmjopen-2023-081969.
Post-traumatic symptoms are common among patients discharged from intensive care units (ICUs), adversely affecting well-being, increasing healthcare utilisation and delaying return to work. Non-pharmacological approaches (eg, music, therapeutic touch and patient diaries) have been suggested as candidate interventions and trauma-focused psychological interventions have been endorsed by international bodies. Neither category of intervention is supported by definitive evidence of long-term clinical effectiveness in patients who have been critically ill. This study assesses the feasibility and acceptability of using eye-movement desensitisation and reprocessing (EMDR) to improve the mental health of ICU survivors.
EMERALD is a multicentre, two-part consent, pilot feasibility study, recruiting discharged ICU survivors from three hospitals in the UK. We are gathering demographics and measuring post-traumatic symptoms, anxiety, depression and quality of life at baseline. Two months after discharge, participants are screened for symptoms of post-traumatic stress disorder (PTSD) using the Impact of Events Scale-Revised (IES-R). Patients with IES-R scores<22 continue in an observation arm for 12 month follow-up. IES-R scores≥22 indicate above-threshold PTSD symptoms and trigger invitation to consent for part B: a randomised controlled trial (RCT) of EMDR versus usual care, with 1:1 randomisation. The study assesses feasibility (recruitment, retention and intervention fidelity) and acceptability (through semistructured interviews), using a theoretical acceptability framework. Clinical outcomes (PTSD, anxiety, depression and quality of life) are collected at baseline, 2 and 12 months, informing power calculations for a definitive RCT, with quantitative and qualitative data convergence guiding RCT refinements.
This study has undergone external expert peer review and is funded by the National Institute for Health and Care Research (grant number: NIHR302160). Ethical approval has been granted by South Central-Hampshire A Research Ethics Committee (IRAS number: 317291). Results will be disseminated through the lay media, social media, peer-reviewed publication and conference presentation.
NCT05591625.
创伤后症状在从重症监护病房（ICU）出院的患者中很常见，这会对患者的幸福感产生不利影响，增加医疗保健的利用，并延迟重返工作岗位。已经提出了非药物方法（例如音乐、治疗性触摸和患者日记）作为候选干预措施，并且国际机构也认可了以创伤为重点的心理干预措施。这两类干预措施都没有得到明确的证据支持，证明它们对患有重病的 ICU 幸存者具有长期的临床效果。本研究评估使用眼动脱敏再处理（EMDR）来改善 ICU 幸存者心理健康的可行性和可接受性。
EMERALD 是一项多中心、两部分同意、试点可行性研究，从英国的三家医院招募出院的 ICU 幸存者。我们正在收集人口统计学数据，并在基线时测量创伤后症状、焦虑、抑郁和生活质量。出院后两个月，使用修订后的事件影响量表（IES-R）对参与者进行创伤后应激障碍（PTSD）症状筛查。IES-R 评分<22 的患者继续进入观察臂进行 12 个月的随访。IES-R 评分≥22 表示存在 PTSD 症状阈值以上的症状，并触发邀请同意进行第二部分：EMDR 与常规护理的随机对照试验（RCT），1:1 随机分组。该研究使用理论可接受性框架评估可行性（招募、保留和干预一致性）和可接受性（通过半结构化访谈）。基线、2 个月和 12 个月收集临床结局（PTSD、焦虑、抑郁和生活质量），为确定性 RCT 提供计算功效，并通过定量和定性数据融合指导 RCT 改进。
这项研究已经经过外部专家同行评审，并由英国国家卫生与保健研究署（NIHR）资助（资助编号：NIHR302160）。已获得南中汉普郡 A 研究伦理委员会的伦理批准（IRAS 编号：317291）。结果将通过大众媒体、社交媒体、同行评议出版物和会议演讲进行传播。
NCT05591625。
