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

NCT04992390 | Completed Results DMC

• 1 other identifier: P1V-GAINS-IN01
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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).

Conditions

Intrusive Memories of Traumatic Event(s)

Outcome Measures

Primary Outcomes (1)

• Number of Intrusive Memories of Traumatic Event(s)

  Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days at week 4 (i.e., Day 22-28). To control for the number of intrusive memories recorded by participants in each experimental group during the run-in/screening week, we included the baseline count of intrusive memories (along with binary arm status) as fixed effect covariates in the Poisson regression model used for primary analysis.

  Week 4

Secondary Outcomes (17)

• Number of Intrusive Memories of Traumatic Event(s)

  Run-in/screening week (immediate intervention arm), week 4 (both arms) and week 8 (delayed intervention arm)

• Intrusive Memory Ratings, Ordinal Items

  Baseline, 4 weeks and 8 weeks

• Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week

  Baseline, 4 weeks and 8 weeks

• Intrusive Memory Ratings, Duration of Interference

  Baseline, 4 weeks and 8 weeks

• Impact of Event Scale-Revised (IES-R)

  Baseline, 4 weeks and 8 weeks

Other Outcomes (6)

• Changes to Health and Work - Discrete Outcomes

  4 weeks and 8 weeks (both arms)

• Changes to Health and Work - Continuous Outcomes

  4 weeks and 8 weeks (both arms)

• Support From Managers and From Family/Friends

  Baseline

Study Arms (2)

Immediate intervention arm

EXPERIMENTAL

Immediate access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks including completing a daily count of the number of their intrusive memories in week 4 (primary outcome).

Behavioral: Brief digital imagery-competing task intervention

Delayed intervention arm

EXPERIMENTAL

Usual care for 4 weeks including completing a daily count of the number of their intrusive memories in week 4 (primary outcome), followed by access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks.

Behavioral: Brief digital imagery-competing task intervention

Interventions

Brief digital imagery-competing task intervention BEHAVIORAL

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).

Delayed intervention arm; Immediate intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• P1vital Products Limited: lead
• Wellcome Trust: collaborator
• Uppsala University: collaborator
• Intensive Care Society: collaborator
• University of Nottingham: collaborator

Study Sites (1)

P1vital Products Limited

Wallingford, Oxfordshire, OX10 8BA, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37658043 BACKGROUND

• 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.

  PMID: 37100869 RESULT

Related Links

• Published paper of primary outcome results (Bayesian analysis)
• Published paper of primary outcome results (Frequentist analysis)

Results Point of Contact

• Title: Dr Amy Beckenstrom
• Organization: P1vital Products Ltd

abeckenstrom@p1vital.com

+44(0)1865 522 030

Study Officials

• Emily Holmes

  Uppsala University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 5, 2021
• Study Start: August 24, 2021
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Study Protocol and Statistical Analysis Plan were made available on the Open Science Framework prior to LPLV. An executive summary of the Clinical Study Report was shared following publication. These together with supporting information (see below) are available indefinitely and with no end date on Open Science Framework Platform.
• Access Criteria: Anonymised research data will be made available on open science frame work (OSF) indefinitely. OSF is an open source web application that is freely accessible to public and scientific community. OSF links are: Protocol, Optimisation SAP (Bayesian) and Descriptive SAP (Frequentist): https://osf.io/2xn5m/ Bayesian paper analysis scripts, database and data code book: https://osf.io/m5cvj/ Frequentist paper analysis scripts, database and data code book: https://osf.io/j9v2z/

Locations

GB (1)