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

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ClinicalTrials.gov Identifier: NCT02080351
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : June 1, 2015
Sponsor:
Collaborators:
Oxford University Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Medical Research Council Cognition and Brain Sciences Unit
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorders Behavioral: Simple cognitive task Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : March 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Feedback Questionnaire [ Time Frame: One month follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02080351


Locations
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United Kingdom
Emergency Department, John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
University of Oxford
Oxford University Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Medical Research Council Cognition and Brain Sciences Unit
Investigators
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Principal Investigator: Lalitha Iyadurai University of Oxford
Principal Investigator: Emily A Holmes MRC Cognition and Brain Sciences Unit, Cambridge

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02080351     History of Changes
Other Study ID Numbers: 12/SC/0485
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders