Preventing Intrusive Memories After Trauma Via a Simple Cognitive Intervention in the Hospital Emergency Department: "EKUT" (Enkel Kognitiv Uppgift Efter Trauma) - A Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of intrusive memories of traumatic event
研究概览
简要总结
This research study is designed to investigate the effects of a simple cognitive task (a memory cue following by playing the computer game "Tetris") on intrusive memories ("flashbacks") and other symptoms after a traumatic event. Patients presenting to a hospital emergency department soon after a traumatic event will be randomly allocated to either the simple cognitive task intervention or control. 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 and less severe related clinical symptoms than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event. Implementation and training aspects in a hospital context will also be explored. Patients use 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 ID: NCT03509792). The primary outcome is the number of intrusive memories of the traumatic event (week 5). The intervention is delivered in emergency departments of 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
- •Experienced or witnessed a traumatic event resulting in admission to the emergency department
- •Met the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Posttraumatic Stress Disorder (PTSD) in that ("The person was exposed 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")
- •Can be seen in the emergency department ca. 6 hours after the traumatic event (day 1)
- •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 following discharge to complete follow-up assessments
- •Have access to an internet enabled smartphone
排除标准
- •Loss of consciousness of > 5 minutes
- •Current intoxication
- •Report a history of severe mental illness
- •Current substance abuse or neurological condition
- •Currently suicidal
- •Other medical reasons (on advice by medical staff)
结局指标
主要结局
Number of intrusive memories of traumatic event
时间窗: Week 5
Number of intrusive memories of traumatic event recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
次要结局
- Posttraumatic Stress Disorder Checklist 5 (PCL-5)(One week and 1, 3, and 6 month follow-up)
- World Health Organization Disability Assessment Schedule 2.0 (WHODAS)(One week and 1, 3, and 6 month follow-up)
- Number of intrusive memories of traumatic event(Week 1)
- Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion symptoms(One week and 1, 3, and 6 month follow-up)
- Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms(One week and 1, 3, and 6 month follow-up)
研究者
Emily Holmes
Professor
Karolinska Institutet