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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intrusive Memories of Traumatic Event(s)
- Sponsor
- P1vital Products Limited
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Number of Intrusive Memories of Traumatic Event(s)
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
- 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)
- PTSD Checklist for DSM-5 (PCL-5) 4-item Version(Baseline, 4 weeks and 8 weeks)
- Sleep Condition Indicator (SCI)(Baseline, 4 weeks and 8 weeks)
- Generalised Anxiety Disorder 2-item Scale (GAD-2)(Baseline, 4 weeks and 8 weeks)
- Patient Health Questionnaire 2-item Version (PHQ-2)(Baseline, 4 weeks and 8 weeks)
- Psychological Outcome Profiles (PSYCHLOPS)(Baseline, 4 weeks and 8 weeks)
- World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0)(Baseline, 4 weeks and 8 weeks)
- 5-level European Quality of Life 5 Dimension (EQ-5D-5L)(Baseline, 4 weeks and 8 weeks)
- Scale of Work Engagement and Burnout (SWEBO)(Time Frame: Baseline, 4 weeks and 8 weeks)
- Sickness Absence(Baseline, 4 weeks and 8 weeks)
- Intention to Leave Job(Baseline, 4 weeks and 8 weeks)
- Weekly Work Pattern, Number of Days Worked(Baseline, 4 weeks and 8 weeks)
- Weekly Work Pattern, Number of Night Shifts Worked(Baseline, 4 weeks and 8 weeks)