Intrusive Memories of Traumatic Event(s) Clinical Trial
Official title:
A Randomised Optimisation Study of a Brief Digital Imagery-competing Task Intervention to Support NHS ICU Staff Experiencing Intrusive Memories of Traumatic Events From Working in the COVID-19 Pandemic
Intensive care unit (ICU) staff are frequently exposed to traumatic events at work (e.g., witnessing patients die), amplified by the COVID-19 pandemic. A significant proportion experience intrusive memories of these events that pop suddenly into mind: these imagery-based memories can disrupt functioning and contribute to posttraumatic stress disorder. Previous research has shown that a brief behavioural intervention can reduce the number of intrusive memories after a traumatic event. In this study we aim to optimise a brief digital intervention to help reduce the number of intrusive memories experienced by ICU staff (primary outcome). We will explore if it can improve work functioning and wellbeing (secondary outcomes). We will recruit approximately 150 ICU staff with intrusive memories of events experienced during the COVID-19 pandemic. The study is funded by the Wellcome Trust (223016/Z/21/Z).
A statistical analysis plan will be prepared prior to the first interim analysis for the outcomes that will guide study optimisation, i.e., primarily the primary outcome. A second statistical analysis plan will be prepared prior to the end of the study, to outline the standard (frequentist) statistical approaches that will be used to analyse the primary, secondary and tertiary data. Regular monitoring will be performed by P1vital Products to verify that the study is conducted and data are generated, documented and reported in compliance with the protocol, GCP and the applicable regulatory requirements. Quality assurance representatives from the Sponsor may carry out an audit of the study in compliance with regulatory guidelines and relevant standard operating procedures. ;
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