Reducing Intrusive Memories After Trauma Via a Simple Cognitive Intervention During COVID-19 in Hospital Staff: "EKUT-P" (Enkel Kognitiv Uppgift Efter Trauma Under COVID-19 - sjukvårdspersonal) - A Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 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
This research study is designed to investigate the effects of a remotely delivered simple cognitive task (a memory cue followed by playing the computer game "Tetris" with mental rotation instructions) on intrusive memories ("flashbacks") and other symptoms after a traumatic event(s). Hospital staff who experienced a work-related traumatic event(s) during the COVID-19 pandemic will be randomly allocated to either the simple cognitive task intervention or control. Randomization to assigned intervention occurs on Day 1, after completion of baseline measures (note: baseline measures are not used in randomization process). Baseline measures include questionnaires on Day 1 and an intrusive memory diary during the previous week (Week 0). Participants will be followed up at one week and one month, and where possible 3 and 6 months. It is predicted that participants given the simple cognitive task intervention will develop fewer intrusive memories, less severe related clinical symptoms, and will show higher functioning (e.g. at work) than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event(s). Implementation and training aspects regarding remote recruitment and intervention delivery in a hospital context will also be explored. Participants use e.g. their smartphone for part of the intervention in the study.
详细描述
This is a Randomised Controlled Trial informed by prior feasibility and pilot work (ClinicalTrials.gov IDs: NCT03509792, NCT04185155). The primary outcome is the number of intrusive memories of the traumatic event(s) (week 5). The intervention is delivered remotely (e.g. via smartphone) with potential remote support (e.g. by phone) to medical staff in Swedish hospitals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Aged 18 or over
- •Clinical work during the COVID-19 pandemic in hospital and care facilities (e.g. ICU, ambulance, intermediate care, ward)
- •Experienced at least one traumatic event in relation to their clinical work as health care staff during the COVID-19 pandemic
- •This/these event(s) at work meet(s) the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Posttraumatic 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"
- •The traumatic event(s) occured since the start of the COVID-19 pandemic
- •Report memory of the accident
- •Fluent in spoken and written Swedish
- •Alert and orientated
- •Have sufficient physical mobility to use their smartphone
- •Willing and able to provide informed consent and complete study procedures
- •Willing and able to be contacted while the study is ongoing
- •Have access to an internet enabled smartphone
- •Experiences distressing intrusive memories (of a traumatic event in relation to their work as health care staff during the COVID-19 pandemic)
- •Has experienced at least two such intrusive memories of a work-related traumatic event during the week before inclusion/exclusion
- •Able and willing to briefly write down these intrusive memories (without going into any detail)
排除标准
- •Loss of consciousness of > 5 minutes in relation to the traumatic event
- •Current intoxication during the traumatic event or in relation to study inclusion
结局指标
主要结局
Number of intrusive memories of traumatic event(s)
时间窗: Week 5
Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
次要结局
- Number of intrusive memories of traumatic event(s)(Week 0 and Week 1)
- Intrusion questionnaire - frequency item(Baseline (Day 1), Week 1 and 5 and 1, 3, and 6 month follow-up)
- Intrusion questionnaire - characteristics(Baseline (Day 1), One week and 1, 3, and 6 month follow-up)
- Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion and avoidance symptoms(Baseline (Day 1), One week and 1, 3, and 6 month follow-up)
- Characteristics of intrusive trauma memories(Baseline (Day 1), Week 1 and week 5)
- Posttraumatic Stress Disorder Checklist 5 (PCL-5) short version(Baseline (Day 1), One week and 1, 3, and 6 month follow-up)
研究者
Emily Holmes
Professor
Karolinska Institutet