CompletedNot Applicable

A Brief GAmeplay Intervention for NHS ICU Staff Affected by COVID-19 Trauma (GAINS Study)

United Kingdom106 participantsStarted 2021-08-24

Plain-language summary

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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 I…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Intrusive Memories of Traumatic Event(s)

Timeframe: Week 4

Trial details

NCT IDNCT04992390

SponsorP1vital Products Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-30

Results submitted2023-12-05

View on ClinicalTrials.gov More Intrusive Memories of Traumatic Event(s) trials