P1vital Products Ltd, Wallingford, Oxfordshire, UK.
Intensive Care Society, 7-9- Breams Buildings, London, UK.
Transl Psychiatry. 2023 Sep 1;13(1):290. doi: 10.1038/s41398-023-02578-0.
Intrusive memories (IMs) after traumatic events can be distressing and disrupt mental health and functioning. We evaluated the impact of a brief remotely-delivered digital imagery-competing task intervention on the number of IMs for intensive care unit (ICU) staff who faced repeated trauma exposure during the COVID-19 pandemic using a two-arm, parallel-group, single-blind randomised controlled trial, with the comparator arm receiving delayed access to active treatment (crossover). Eligible participants worked clinically in a UK NHS ICU during the pandemic and had at least 3 IMs of work-related traumatic events in the week before recruitment. Participants were randomly assigned (1:1) to immediate (weeks 1-4) or delayed (weeks 5-8) intervention access. Sequential Bayesian analyses to optimise the intervention and increase trial efficiency are reported elsewhere [1]. The primary endpoint for the pre-specified frequentist analysis of the final study population compared the number of IMs experienced in week 4 between the immediate and delayed access arms. Secondary outcomes included clinical symptoms, work functioning and wellbeing. Safety was assessed throughout the trial by scheduled questions and free report. All analyses were undertaken on an intention-to-treat basis (86 randomised participants). There were significantly fewer intrusive memories during week 4 in the immediate (median = 1, IQR = 0-3, n = 43), compared to the comparator delayed arm (median = 10, IQR = 6-17, n = 43), IRR 0.31, 95% CI: 0.20-0.48, p < 0.001. After crossover, the delayed arm also showed a significant reduction in IMs at week 8 compared to week 4. There were convergent findings for symptoms of PTSD, insomnia and anxiety, work engagement and burnout, general functioning and quality of life. The intervention was found safe and acceptable to participants. All adverse events were unrelated to the study. Our study provides the first evidence of a benefit on reducing IMs, improving other clinical symptoms, work functioning and wellbeing, as well as safety of a brief remotely-delivered digital imagery-competing task intervention. An efficacy trial with an active control and longer follow-up is warranted. The trial is registered at ClinicalTrials.gov (NCT04992390).
创伤后侵入性记忆(IMs)会令人痛苦,并扰乱心理健康和功能。我们评估了一种简短的远程数字图像竞争任务干预对在 COVID-19 大流行期间反复暴露于创伤的重症监护病房(ICU)工作人员 IMs 数量的影响,该研究采用了双臂、平行组、单盲随机对照试验,对照组在延迟后获得主动治疗(交叉)。合格的参与者在大流行期间在英国国民保健署的 ICU 中进行临床工作,并且在招募前一周内至少有 3 次与工作相关的创伤性事件的 IMs。参与者被随机分配(1:1)接受即时(第 1-4 周)或延迟(第 5-8 周)干预。在别处报告了优化干预措施和提高试验效率的序贯贝叶斯分析[1]。对最终研究人群的预设频率分析的主要终点是比较即时和延迟访问臂在第 4 周经历的 IMs 数量。次要结局包括临床症状、工作功能和幸福感。通过预定问题和自由报告在整个试验过程中评估安全性。所有分析均基于意向治疗进行(86 名随机参与者)。在即时组(中位数=1,IQR=0-3,n=43),与对照组延迟组(中位数=10,IQR=6-17,n=43)相比,第 4 周时的侵入性记忆明显减少,IRR 0.31,95%CI:0.20-0.48,p<0.001。交叉后,延迟组在第 8 周时的 IMs 也明显少于第 4 周。创伤后应激障碍、失眠和焦虑、工作投入和倦怠、一般功能和生活质量的症状均有收敛性发现。该干预措施被发现对参与者是安全且可接受的。所有不良事件均与研究无关。我们的研究首次提供了一种简短的远程数字图像竞争任务干预可以减少 IMs、改善其他临床症状、工作功能和幸福感以及安全性的证据。需要进行一项有积极对照和更长随访时间的疗效试验。该试验在 ClinicalTrials.gov 注册(NCT04992390)。