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

May 29, 2015 updated by: University of Oxford

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Emergency Department, John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simple cognitive task
A memory reactivation cue followed by playing the computer game "Tetris"
Behavioral: Simple cognitive task
No Intervention: Usual care
Usual care in the emergency department

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Feedback Questionnaire
Time Frame: One month follow-up
One month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

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

Investigators

  • Principal Investigator: Lalitha Iyadurai, University of Oxford
  • Principal Investigator: Emily A Holmes, MRC Cognition and Brain Sciences Unit, Cambridge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/SC/0485

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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