A Randomised Controlled Trial of a Brief Cognitive Task Intervention to Support NHS Staff Experiencing Intrusive Memories of Traumatic Events From Working in the COVID- 19 Pandemic.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Number of intrusive memories of traumatic event(s)
研究概览
简要总结
Frontline healthcare 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: they can disrupt functioning and can contribute to post-traumatic 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 will test the effect of a digital imagery-competing task, a digital music-listening task and treatment as usual (TAU) for National Health Service (NHS) staff with intrusive memories of work-related traumatic events from the pandemic. We test the effect on the number of intrusive memories (primary outcome), and other clinical symptoms (PTSD, anxiety, depression, and insomnia), in addition to work functioning, general functioning and quality of life (secondary outcomes). Intervention feasibility, acceptability and implementation will also be explored (additional outcomes). We will recruit approximately 150 NHS staff (via the Intensive Care Society, social media and direct advertising by NHS Trusts) with intrusive memories of traumatic events experienced during the COVID-19 pandemic.
The study is funded by the Wellcome Trust (223016/Z/21/Z).
详细描述
A statistical analysis plan will be prepared prior to the first interim analysis using Bayesian analyses for statistical inference.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 or above.
- •Able to read, write and speak in English.
- •Worked in a clinical role with COVID-19 patients in the NHS during the COVID-19 pandemic.
- •Experienced at least one traumatic event related to their clinical work during the COVID- 9 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
- •Willing and able to be contacted by the research team during the study period.
- •Have not taken part in a previous study of this intervention from this research team
排除标准
- •Have fewer than three intrusive memories during the run-in week.
研究组 & 干预措施
Treatment As Usual
Access to routine care that participants would otherwise receive if having intrusive memories of traumatic events for 24 weeks.
干预措施: Treatment As Usual (Other)
Brief digital imagery-competing task
Access to a brief digital imagery-competing task for 24 weeks (first 4 weeks with optional researcher support).
干预措施: Brief digital imagery-competing task (Behavioral)
Brief digital music-listening task
Access to a brief digital music-listening task for 24 weeks (first 4 weeks with optional researcher support).
干预措施: Brief digital music-listening task (Behavioral)
结局指标
主要结局
Number of intrusive memories of traumatic event(s)
时间窗: Week 4 (all arms) controlling for run-in/baseline week
Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
次要结局
- Scale of Work Engagement and Burnout (SWEBO)(Baseline, 4 weeks, 12 weeks and 24 weeks (all arms))
- Number of intrusive memories of traumatic event(s)(Weeks 12 and 24 (all arms) controlling for run-in/baseline week)
- Sleep Condition Indicator (SCI)(Baseline, 4 weeks, 12 weeks and 24 weeks (all arms))
- Generalised Anxiety Disorder 2-item scale (GAD-2)(Baseline, 4 weeks, 12 weeks and 24 weeks (all arms))
- Intention to leave job(Baseline, 4 weeks, 12 weeks and 24 weeks (all arms))
- Sickness absence(Baseline, 4 weeks, 12 weeks and 24 weeks (all arms))
- 5-level European Quality of Life 5 Dimension (EQ-5D-5L)(Baseline, 4 weeks, 12 weeks and 24 weeks (all arms))
- World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0)(Baseline, 4 weeks, 12 weeks and 24 weeks (all arms))
- Patient Health Questionnaire 2-item version (PHQ-2)(Baseline, 4 weeks, 12 weeks and 24 weeks (all arms))
- Intrusive memory ratings(Baseline, 4 weeks, 12 weeks and 24 weeks (all arms))
- PTSD Checklist for DSM-5 (PCL-5)(Baseline, 4 weeks, 12 weeks and 24 weeks (all arms))