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Completed

NCT Number: NCT02080351

A Simple Cognitive Task to Reduce the Build-Up of Flashbacks After a Road Traffic Accident

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.

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Key information

Conditions

Post-Traumatic Stress Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department, John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Loss of consciousness of > 5 minutes
  • Current intoxication
  • Report a history of severe mental illness
  • Current substance abuse or neurological condition
  • Currently suicidal

Treatment and study plan

Simple cognitive task

Behavioral

Primary outcomes

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

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

Secondary outcomes

  1. Post-traumatic Stress Diagnostic Scale (PDS)

    Time frame: One week and one month follow-up

  2. Impact of Event Scale - Revised (IES-R)

    Time frame: One week and one month follow-up

  3. Hospital Anxiety and Depression Scale (HADS)

    Time frame: One week and one month follow-up

Other outcomes

  1. Feedback Questionnaire

    Time frame: One month follow-up

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Medical Research Council Cognition and Brain Sciences Unit
  • National Institute for Health Research, United Kingdom
  • Oxford University Hospitals NHS Trust

Registry information

Official study title

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

Acronym: SCARTA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2014
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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