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Completed

NCT Number: NCT04992390

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

P1vital Products Limited

Wallingford, Oxfordshire, OX10 8BA, United Kingdom

About this study

A statistical analysis plan was prepared prior to the first interim analysis for the outcomes that guided study optimisation, i.e., primarily the primary outcome.

A second statistical analysis plan was prepared prior to the end of the study, outlining the standard (frequentist) statistical approaches used to analyse the primary, secondary and tertiary data.

Regular monitoring 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Number of Intrusive Memories of Traumatic Event(s)

    Time frame: Week 4

    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.

Secondary outcomes

  1. Number of Intrusive Memories of Traumatic Event(s)

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

    Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.

    Total number of intrusive memories reported in Week 4 compared to run-in/screening week for the immediate intervention group and Week 8 compared to Week 4 for the delayed intervention group (i.e., within-group comparisons).

  2. Intrusive Memory Ratings, Ordinal Items

    Time frame: Baseline, 4 weeks and 8 weeks

    The 9-item questionnaire assesses a number of intrusive memories characteristics. These characteristics include frequency (7-point categorical response from 'never' to 'many times a day); distress (0=not at all to 10=extremely); disruption to concentration (0=not at all to 10=extremely); interference with what you were doing (how much (0=not at all to 10=extremely) and for how long (6-point categorical response from '<1min' to '+60mins')); impact on work functioning (0=not at all to 10=extremely) and in what ways (open text response)); impact on functioning in other areas of life (how much (0= not at all to 10 = extremely) and in what ways (open text response)).

    Five quantitative outcomes are presented here. For two further ordinal items, frequency and duration of interference, please see below.

  3. Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week

    Time frame: Baseline, 4 weeks and 8 weeks

    The 9-item questionnaire assesses a number of intrusive memories characteristics. Five ordinal items are presented separately (see "Intrusive Memory Ratings, ordinal items"). Here we present one of the two categorical items. This item assesses the frequency of intrusive memories over the past week (7-point categorical response from 'never' to 'many times a day').

  4. Intrusive Memory Ratings, Duration of Interference

    Time frame: Baseline, 4 weeks and 8 weeks

    The 9-item questionnaire assesses a number of intrusive memories characteristics. Five ordinal items are presented separately (see "Intrusive Memory Ratings, ordinal items"). Here we present one of the two categorical items. This item assesses the duration for which an intrusive memory interfered with with what participants were doing (6-point categorical response from '<1min' to '+60mins').

  5. Impact of Event Scale-Revised (IES-R)

    Time frame: Baseline, 4 weeks and 8 weeks

    This 22-item questionnaire assesses subjective distress after a traumatic event (with reference to the events for which participants are taking part in the study).

    Items are rated for how distressing they have been during the past 7 days on a 5-point ordinal scale ranging from 0 ("not at all") to 4 ("extremely"). The measure consists of three subscales with subscale and total scores calculated as the mean of all items: intrusion subscale (8-items, score range 0-4), avoidance subscale (8-items, score range 0-4) and hyperarousal subscale (6-items, score range 0-4), and total score (all 22-items, score range 0-4). We will analyse total score as the mean of all 22-items, and subscales as the mean of items in each subscale separately. Higher scores indicate higher levels of subjective distress after a traumatic event.

  6. PTSD Checklist for DSM-5 (PCL-5) 4-item Version

    Time frame: Baseline, 4 weeks and 8 weeks

    This shortened 4-item version of the PCL-5 assesses symptoms of PTSD over the last month.

    Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total score ranges from 0 to 16 (cut-off for possible PTSD is 10 or above).

  7. Sleep Condition Indicator (SCI)

    Time frame: Baseline, 4 weeks and 8 weeks

    This 8-item scale measures sleep problems against the DSM-5 criteria for insomnia disorder.

    Item responses are each scored 0-4, with scores from 0 to 2 indicating threshold criteria for insomnia disorder. Total score ranges 0-32, with a higher score indicating better sleep (cut-off for possible insomnia disorder is a total score from 0 to 2).

  8. Generalised Anxiety Disorder 2-item Scale (GAD-2)

    Time frame: Baseline, 4 weeks and 8 weeks

    Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day"). Total score is the sum of both items and ranges from 0 to 6 (cut-off for possible GAD is 3 or above).

  9. Patient Health Questionnaire 2-item Version (PHQ-2)

    Time frame: Baseline, 4 weeks and 8 weeks

    This 2-item short-form self-report measure assesses symptoms of depression.

    Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day"). Total score is the sum of both items and ranges from 0 to 6 (cut-off for possible major depressive disorder is 3 or above).

  10. Psychological Outcome Profiles (PSYCHLOPS)

    Time frame: Baseline, 4 weeks and 8 weeks

    This measure consists of 4 questions that are scored and designed to assess the impact of a person's intrusive memories.

    Questions 1b, 2b, 3b, and 4 are scored. These have a six-point ordinal scale ranging from 0 to 5 and are summed to generate a total score from 0 to 20. Higher values indicate the person is more severely affected.

  11. World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0)

    Time frame: Baseline, 4 weeks and 8 weeks

    The 12-item, self-report version of the WHODAS 2.0 will be used to assess difficulties in relation to the impact of intrusive memories.

    Respondents rate how much difficulty they have had in each area in the past 30 days, from 0 (none) to 4 (extreme or cannot do). The overall score is calculated as a percentage of the maximum possible score (i.e., 48 points).

  12. 5-level European Quality of Life 5 Dimension (EQ-5D-5L)

    Time frame: Baseline, 4 weeks and 8 weeks

    The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief measure for assessing general quality of life and health status.

    Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale. 5 items are scored on a 5-point ordinal scale from 'no problem' (1) to 'highest level of problems' (5). Respondents also self-rate their overall health today on a visual analogue scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine). Scores are analysed separately (not summed).

    Here we present the 'overall health' visual analogue scale item.

  13. Scale of Work Engagement and Burnout (SWEBO)

    Time frame: Time Frame: Baseline, 4 weeks and 8 weeks

    This 19-item self-report measure assesses work engagement and burnout. Respondents rate how often they have felt each descriptive item in the past two weeks, from 1 (not at all) to 4 (all the time).

    The work engagement subscale consists of 10-items assessing three dimensions (attentiveness, vigour, and dedication) with each dimension consisting of 4-, 3-, and 3-items respectively. Greater scores indicate a higher (i.e., better) degree of work engagement.

    The burnout subscale consists of 9-items assessing three dimensions (Engagement, Exhaustion, and Disengagement), with each dimension consisting of 3-items. Greater scores indicate a higher (i.e., functionally worse) degree of burnout.

    A mean score is calculated for the work engagement and burnout subscales, from individual items (for both subscales, scores range 1-4).

  14. Sickness Absence

    Time frame: Baseline, 4 weeks and 8 weeks

    Single item assessing self-reported number of sick days taken from work in the last 4 weeks. Total scoring includes total number of sick days.

  15. Intention to Leave Job

    Time frame: Baseline, 4 weeks and 8 weeks

    This 3 items questionnaire is used to assess participants' intention to leave their job e.g. "I think a lot about leaving the job", each rated from 1 (strongly agree) to 5 (strongly disagree). The total score ranges 3 to 15, with a lower score indicating stronger intention to leave the job.

  16. Weekly Work Pattern, Number of Days Worked

    Time frame: Baseline, 4 weeks and 8 weeks

    One item asses the number of days worked in the last week (both with responses from 0 to 7 days).

  17. Weekly Work Pattern, Number of Night Shifts Worked

    Time frame: Baseline, 4 weeks and 8 weeks

    One item asses the number of night shifts worked in the last week (both with responses from 0 to 7).

Other outcomes

  1. Changes to Health and Work - Discrete Outcomes

    Time frame: 4 weeks and 8 weeks (both arms)

    The 6-item questionnaire will be used to assess the occurrence of any new traumatic events (presented below); any additional stressful life events (e.g. relationship problems, financial problems), new treatments received, social support received, changes to the job, or changes to the number of hours worked per week since the last assessment (see Supplementary Table 4 in Iyadurai et al., 2023).

  2. Changes to Health and Work - Continuous Outcomes

    Time frame: 4 weeks and 8 weeks (both arms)

    The 6-item questionnaire will be used to assess the occurrence of any new traumatic events (presented below); any additional stressful life events (e.g. relationship problems, financial problems), new treatments received, social support received, changes to the job, or changes to the number of hours worked per week since the last assessment (see Supplementary Table 4 in Iyadurai et al., 2023).

  3. Support From Managers and From Family/Friends

    Time frame: Baseline

    The 2 item questionnaire asks "During the COVID-19 pandemic, how well supported have you been by your supervisors/managers?" and "how well supported have you been by your family and friends?" The response is rated as "not at all", "quite a bit", "moderately", "quite a bit", or "extremely"

  4. Optimisation Assessment

    Time frame: Baseline, 4 weeks and 8 weeks

    Rates of recruitment, intervention use/adherence, outcome measure completion and participant attrition will be assessed.

  5. Feedback Questionnaire

    Time frame: Week 4 (immediate intervention arm), Week 8 (delayed intervention arm)

    This measure assesses participants' feedback for the intervention. Eight quantitative items assess how easy, helpful, distressing, burdensome and acceptable participants found the intervention, how willing they would be to use it in the future, how confident they would be in recommending it to a friend and how much they feel it could be used to support staff within NHS ICUs, with each rated on a 11-point ordinal scale from 0 (not at all) to 10 (very).

    For all items, a higher score indicates greater acceptability for the intervention. The two items assessing distress and burden are reverse coded such that higher scores (e.g., 10) indicate lower distress and burden respectively.

    A total score of all eight ordinal items (range 0-80) is calculated as the sum of items.

  6. Optional Qualitative Interview

    Time frame: Week 5 (immediate intervention arm), Week 9 (delayed intervention arm)

    Qualitative interview will consist of a number of questions designed to gain an in-depth understanding of participants' experience of using the intervention, including acceptability, improvement suggestions, training/psychoeducation materials, potential barriers/facilitators to recruitment and uptake, and support needed for remote intervention delivery.

Sponsors and collaborators

Lead sponsor

P1vital Products Limited

Industry

Collaborators

  • Intensive Care Society
  • University of Nottingham
  • Uppsala University
  • Wellcome Trust

Registry information

Official study 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

Acronym: GAINS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2021
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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