Clinical trial NCT04992390: A Brief GAmeplay Intervention for NHS ICU Staff Affected by COVID-19 Trauma (GAINS Study)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Memories of Traumatic Event(s)
Lead sponsor: P1vital Products Limited
Sponsor class: INDUSTRY
Collaborators: name: Wellcome Trust
name: Uppsala University
name: Intensive Care Society
name: University of Nottingham
First posted: 2021-08-05
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

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.

Primary outcomes:
measure: Number of intrusive memories of traumatic event(s)
timeFrame: Week 4 (both arms) and Controlling for Run in week (both arms)
Secondary outcomes:
measure: Number of intrusive memories of traumatic event(s)
timeFrame: Run-in week (immediate intervention arm) , week 4 (both arms) and week 8 (delayed intervention arm)
measure: Intrusive memory ratings
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Impact of Event Scale-Revised (IES-R)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: PTSD Checklist for DSM-5 (PCL-5) 4-item version
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Sleep Condition Indicator (SCI)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Generalised Anxiety Disorder 2-item scale (GAD-2)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Patient Health Questionnaire 2-item version (PHQ-2)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Psychological Outcome Profiles (PSYCHLOPS)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: 5-level European Quality of Life 5 Dimension (EQ-5D-5L)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Scale of Work Engagement and Burnout (SWEBO)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Sickness absence
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Intention to leave job
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Weekly Work Pattern
timeFrame: Baseline, 4 weeks and 8 weeks
Other outcomes:
measure: Support from managers and from family/friends
timeFrame: Baseline
measure: Changes to health and work
timeFrame: 4 weeks and 8 weeks (both arms)
measure: Optimisation Assessment
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Feedback questionnaire
timeFrame: Week 4 (immediate intervention arm), Week 8 (delayed intervention arm)
measure: Optional qualitative interview
timeFrame: Week 5 (immediate intervention arm), Week 9 (delayed intervention arm)
Locations:
city: Wallingford
country: United Kingdom
facility: P1vital Products Limited
state: Oxfordshire
Study officials:
affiliation: Uppsala University
name: Emily Holmes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iyadurai L, Highfield J, Kanstrup M, Markham A, Ramineni V, Guo B, Jaki T, Kingslake J, Goodwin GM, Summers C, Bonsall MB, Holmes EA. Reducing intrusive memories after trauma via an imagery-competing task intervention in COVID-19 intensive care staff: a randomised controlled trial. Transl Psychiatry. 2023 Sep 1;13(1):290. doi: 10.1038/s41398-023-02578-0.
citation: Ramineni V, Millroth P, Iyadurai L, Jaki T, Kingslake J, Highfield J, Summers C, Bonsall MB, Holmes EA. Treating intrusive memories after trauma in healthcare workers: a Bayesian adaptive randomised trial developing an imagery-competing task intervention. Mol Psychiatry. 2023 Jul;28(7):2985-2994. doi: 10.1038/s41380-023-02062-7. Epub 2023 Apr 26.