N/A
N=102
A Brief GAmeplay Intervention for NHS ICU Staff Affected by COVID-19 Trauma (GAINS Study)
Intrusive Memories of Traumatic Event(s)
Bottom Line
View on ClinicalTrials.gov: NCT04992390 ↗Enrolled (actual)
102
Serious AEs
0.4%
Results posted
Jul 2025
Primary outcome: Primary: Number of Intrusive Memories of Traumatic Event(s) — 14.5; 14.0; 1.0; 10.0 Number of intrusive memories — p=<= 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief digital imagery-competing task intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- P1vital Products Limited
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Intrusive Memories of Traumatic Event(s) |
14.00; 14.50; 10.00; 1.00; 1.00 | <= 0.001 sig |
| SECONDARY Number of Intrusive Memories of Traumatic Event(s) |
14.00; 14.50; 10.00; 1.00; 1.00 | <= 0.001 sig |
| SECONDARY Intrusive Memory Ratings, Ordinal Items |
6.00; 6.02; 5.53; 2.86; 2.87; 2.00 | <= 0.001 sig |
| SECONDARY Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week |
0; 0; 0; 1; 1; 0 | — |
| SECONDARY Intrusive Memory Ratings, Duration of Interference |
17; 16; 21; 17; 3; 9 | — |
| SECONDARY Impact of Event Scale-Revised (IES-R) |
2.17; 2.24; 1.70; 0.83; 0.78; 0.58 | <= 0.001 sig |
| SECONDARY PTSD Checklist for DSM-5 (PCL-5) 4-item Version |
8.71; 8.0; 4.26; 6.74; 2.35; 2.87 | <= 0.001 sig |
| SECONDARY Sleep Condition Indicator (SCI) |
12.37; 12.71; 19.13; 12.71; 20.65; 19.23 | <= 0.001 sig |
| SECONDARY Generalised Anxiety Disorder 2-item Scale (GAD-2) |
3.83; 3.07; 2.07; 2.84; 1.65; 1.29 | <=0.05 |
| SECONDARY Patient Health Questionnaire 2-item Version (PHQ-2) |
2.76; 2.26; 1.53; 1.92; 1.23; 1.23 | > .05 |
| SECONDARY Psychological Outcome Profiles (PSYCHLOPS) |
14.20; 13.29; 6.97; 12.13; 5.65; 6.03 | <= 0.001 sig |
| SECONDARY World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0) |
25.0; 21.88; 13.54; 22.37; 10.76; 11.90 | <= 0.001 sig |
| SECONDARY 5-level European Quality of Life 5 Dimension (EQ-5D-5L) |
66.03; 67.83; 78.68; 65.13; 76.29; 78.23 | <= 0.01 sig |
| SECONDARY Scale of Work Engagement and Burnout (SWEBO) |
2.19; 2.03; 2.10; 2.59; 2.50; 2.66 | <= 0.001 sig |
| SECONDARY Sickness Absence |
3.80; 3.21; 3.79; 3.45; 1.42; 1.65 | > .05 |
| SECONDARY Intention to Leave Job |
8.65; 9.19; 9.36; 10.32; 9.94; 10.26 | > .05 |
| SECONDARY Weekly Work Pattern, Number of Days Worked |
3.14; 3.21; 3.26; 2.66; 2.83; 3.48 | >.05 |
| SECONDARY Weekly Work Pattern, Number of Night Shifts Worked |
0.65; 1.0; 0.55; 0.83; 0.57; 0.77 | <.05 sig |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04992390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.