Preventing Intrusive Memories After Trauma Via a Simple Cognitive Intervention in the Hospital Emergency Department: "EKUT" (Enkel Kognitiv Uppgift Efter Trauma)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 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 clinical symptoms than those who are not. This will inform the potential future development of a simple technique to prevent distressing psychological symptoms after a traumatic event. Implementation aspects in a new hospital context will also be explored. Patients use their smartphone for part of the intervention in the study.
详细描述
This is an explorative pilot study, which will guide the design of a future Randomised Controlled Trial. The main aim of the present study is not a statistical significance test, the results will be descriptive, and will include pilot analyses to obtain an estimate of effect size between groups of the current primary outcome measure.
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
- None
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 for example a road traffic accident (as a driver, passenger, motorcyclist, cyclist or pedestrian)
- •Met the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Post-Traumatic Stress Disorder (PTSD) ("The person was exposed to: death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence" by "Direct exposure" or "Witnessing the trauma") )
- •Can be seen in the emergency department within 6 hours after the traumatic event
- •Report memory of the accident
- •Fluent in Swedish
- •Alert and orientated
- •Have sufficient physical mobility use the intervention platform (their smartphone) to play a computer game or engage in other smartphone activities at the point of taking informed consent (i.e. sufficient use of hands).
- •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
- •in addition to point above "can be seen in the emergency department within 6 hours after the traumatic event", from mid May 2019, to also include patients presenting later to the emergency department if still within 72 hours of the event
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
研究组 & 干预措施
Simple cognitive task
A memory cue followed by playing the computer game "Tetris" on own smartphone. Options to engage in self-administered booster sessions after day 1.
干预措施: Simple cognitive task (Behavioral)
Attention placebo
Smartphone activity for same amount of time.
干预措施: Attention placebo (Behavioral)
结局指标
主要结局
Number of intrusive memories of traumatic event
时间窗: Week 1
Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) for 7 days
次要结局
- Number of intrusive memories of traumatic event(1 month)
- Impact of Event Scale - Revised (IES-R) Intrusion Subscale: Degree of subjective distress of post-trauma symptoms in the intrusion (re-experiencing) symptoms cluster(One week and 1, 3, and 6month follow-up)
- Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms(One week 1, 3, and 6 month follow-up)
- Perceived Stress Scale (PSS)(1 month follow-up)
- Work and Social Adjustment Scale (WSAS): Daily function([One week and 1, 3, and 6 month follow-up])
研究者
Emily Holmes
Professor
Karolinska Institutet