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

Not Applicable

Completed

Conditions: Intrusive Memories of Traumatic Event(s)

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 106

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Intrusive Memories of Traumatic Event(s)	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 Outcome Measures

Name	Time	Method
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)	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).
Intrusive Memory Ratings, Ordinal Items	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.
Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week	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').
Intrusive Memory Ratings, Duration of Interference	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').
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 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.
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).
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.
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 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.
Scale of Work Engagement and Burnout (SWEBO)	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).
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.
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.
Weekly Work Pattern, Number of Days Worked	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).
Weekly Work Pattern, Number of Night Shifts Worked	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).

Trial Locations

Locations (1): P1vital Products Limited
🇬🇧
Wallingford, Oxfordshire, United Kingdom
P1vital Products Limited
🇬🇧Wallingford, Oxfordshire, United Kingdom