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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Intrusive Memories of Traumatic Event(s)

Intervention / Treatment
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* Behavioral: Brief digital imagery-competing task intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate intervention arm<br>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<br>* 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).<br>|
| Experimental: Delayed intervention arm<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 4 (both arms) and Controlling for Run in week (both arms) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Total number of intrusive memories reported in Week 4 compared to baseline for the immediate intervention group and Week 8 compared to Week 4 for the delayed intervention group (within-group comparisons). | Run-in week (immediate intervention arm) , week 4 (both arms) and week 8 (delayed intervention arm) | 
| Intrusive memory ratings | 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)). | Baseline, 4 weeks and 8 weeks | 
| Impact of Event Scale-Revised (IES-R) | 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 scale ranging from 0 (not at all) to 4 (extremely). Scores are calculated for the intrusion, avoidance and hyperarousal subscales and total score. We will analyse total score (mean of all 22 items) and subscales separately (mean of items in each subscale). | Baseline, 4 weeks and 8 weeks | 
| PTSD Checklist for DSM-5 (PCL-5) 4-item version | 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). | Baseline, 4 weeks and 8 weeks | 
| Sleep Condition Indicator (SCI) | 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). | Baseline, 4 weeks and 8 weeks | 
| Generalised Anxiety Disorder 2-item scale (GAD-2) | 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). | Baseline, 4 weeks and 8 weeks | 
| Patient Health Questionnaire 2-item version (PHQ-2) | 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). | Baseline, 4 weeks and 8 weeks | 
| Psychological Outcome Profiles (PSYCHLOPS) | 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. | Baseline, 4 weeks and 8 weeks | 
| World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0) | 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). | Baseline, 4 weeks and 8 weeks | 
| 5-level European Quality of Life 5 Dimension (EQ-5D-5L) | 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 rate their overall health today from 0 (the worst health you can imagine) to 100 (the best health you can imagine). Scores are analysed separately (not summed). | Baseline, 4 weeks and 8 weeks | 
| Scale of Work Engagement and Burnout (SWEBO) | This 18-item self-report measure assesses work engagement and burnout. The work engagement subscale consists of 9 items assessing three dimensions (vigour, attentiveness, dedication). Respondents rate how often they have felt each descriptive in the past two weeks, from 1 (not at all) to 4 (all the time). The mean score is calculated for two subscales: engagement and burnout (9 items each). | Baseline, 4 weeks and 8 weeks | 
| Sickness absence | 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. | Baseline, 4 weeks and 8 weeks | 
| Intention to leave job | 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. | Baseline, 4 weeks and 8 weeks | 
| Weekly Work Pattern | Two items asses the number of days worked and number of night shifts worked in the last week (both with responses from 0 to 7). Items are examine separately (not summed). | Baseline, 4 weeks and 8 weeks |