A Brief GAmeplay Intervention for NHS ICU Staff Affected by COVID-19 Trauma (GAINS Study)
- Conditions
- Intrusive Memories of Traumatic Event(s)
- Interventions
- Behavioral: Brief digital imagery-competing task intervention
- Registration Number
- NCT04992390
- Lead Sponsor
- P1vital Products Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate intervention arm Brief digital imagery-competing task intervention 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). Delayed intervention arm Brief digital imagery-competing task intervention 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.
- Primary Outcome Measures
Name Time Method Number of intrusive memories of traumatic event(s) Week 4 (both arms) and Controlling for Run in week (both arms) Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
- Secondary Outcome Measures
Name Time Method Sickness absence 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.
Patient Health Questionnaire 2-item version (PHQ-2) 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).Psychological Outcome Profiles (PSYCHLOPS) 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.Number of intrusive memories of traumatic event(s) Run-in 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 baseline for the immediate intervention group and Week 8 compared to Week 4 for the delayed intervention group (within-group comparisons).Impact of Event Scale-Revised (IES-R) 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 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).Intention to leave job 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.
Intrusive memory ratings 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)).
World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0) 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).5-level European Quality of Life 5 Dimension (EQ-5D-5L) 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 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).Weekly Work Pattern Baseline, 4 weeks and 8 weeks 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).
PTSD Checklist for DSM-5 (PCL-5) 4-item version 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).Sleep Condition Indicator (SCI) 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).Generalised Anxiety Disorder 2-item scale (GAD-2) 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).
Scale of Work Engagement and Burnout (SWEBO) Baseline, 4 weeks and 8 weeks 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).
Trial Locations
- Locations (1)
P1vital Products Limited
🇬🇧Wallingford, Oxfordshire, United Kingdom