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.
Behavioral: Brief digital imagery-competing task intervention
First session guided by a researcher: A memory cue followed by playing the brief digital imagery-competing task with mental rotation instructions.
Option to engage in self-administered/guided sessions after the first session and record their intrusive memories (symptom monitoring).
Inclusion criteria:
- Aged 18 or above.
- Able to read, write and speak in English.
- Worked in a clinical role in an NHS Intensive Care Unit or equivalent during the
COVID-19 pandemic (e.g. as a member of ICU staff or deployed to work in the ICU during
the pandemic)
- Experienced at least one traumatic event related to their work during the COVID-19
pandemic, meeting criterion A of the Diagnostic and Statistical Manual of Mental
Disorders, 5th edition (DSM-5) criteria for Post-Traumatic Stress Disorder (PTSD):
"exposure to actual or threatened death, serious injury, or sexual violence" by
"directly experiencing the traumatic event(s)" or "witnessing, in person, the event(s)
as it occurred to others"
- Experience intrusive memories of the traumatic event(s).
- Experienced at least three intrusive memories in the week prior to screening.
- Have internet access.
- Willing and able to provide informed consent and complete study procedures (including
briefly listing their intrusive memories (without going into any detail), and playing
the brief digital imagery-competing task with particular mental rotation instructions,
and completing an online intrusive memory diary).
- Willing and able to be contacted by the research team during the study period.
Exclusion criteria:
• Have fewer than three intrusive memories during the run-in week.
We will not exclude those undergoing other treatment for PTSD or its symptoms, so the study
is as inclusive as possible to meet the challenges ICU staff are facing during the COVID-19
pandemic.
P1vital Products Limited
Wallingford, Oxfordshire, United Kingdom
Emily Holmes, Principal Investigator
Uppsala University