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临床试验/NCT02080351
NCT02080351已完成不适用

A Simple Cognitive Task to Reduce the Build-Up of Flashbacks After a Road Traffic Accident: A Randomised Controlled Study in an Emergency Department

University of Oxford1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
1
主要终点
Number of flashbacks recorded by participants in a Flashback Record in the week after the accident

研究概览

简要总结

This research study is designed to investigate the effects of a simple cognitive task (a memory reactivation cue following by playing the computer game "Tetris") on flashbacks and other post-traumatic stress symptoms after a road traffic accident. Patients presenting to a hospital emergency department soon after a road traffic accident will be randomly allocated to either the simple cognitive task intervention or usual care. Participants will be followed up at one week and one month. It is predicted that participants given the simple cognitive task intervention will develop fewer flashbacks 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.

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 road traffic accident (as a driver, passenger, motorcyclist, cyclist or pedestrian)
  • •Met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criterion A1 for Post-Traumatic Stress Disorder (PTSD) ("experienced, witnessed, or confronted with actual or threatened death or serious injury)
  • •Can be seen in the emergency department within 6 hours of leaving the scene of the accident
  • •Report memory of the accident
  • •Fluent in written and spoken English
  • •Alert and orientated, Glasgow Coma Scale score (GCS) = 15
  • •Have sufficient physical mobility to play a computer game on the intervention platform (a Nintendo DS) at the point of taking informed consent
  • •Willing and able to provide informed consent and complete study procedures
  • •Willing and able to be contacted following discharge to complete follow-up assessments

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

Experimental

A memory reactivation cue followed by playing the computer game "Tetris"

干预措施: Simple cognitive task (Behavioral)

Usual care

No Intervention

Usual care in the emergency department

结局指标

主要结局

Number of flashbacks recorded by participants in a Flashback Record in the week after the accident

时间窗: Within one week after the accident (Flashback Record will be returned to a researcher at one week follow-up)

次要结局

  • Impact of Event Scale - Revised (IES-R)(One week and one month follow-up)
  • Post-traumatic Stress Diagnostic Scale (PDS)(One week and one month follow-up)
  • Hospital Anxiety and Depression Scale (HADS)(One week and one month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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