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Trial record 1 of 1 for:    NCT02080351
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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

Tracking Information
First Submitted Date  ICMJE March 4, 2014
First Posted Date  ICMJE March 6, 2014
Last Update Posted Date June 1, 2015
Study Start Date  ICMJE March 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2014)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2014)
Flashback Record [ Time Frame: One week follow-up ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2014)
  • Post-traumatic Stress Diagnostic Scale (PDS) [ Time Frame: One week and one month follow-up ]
  • Impact of Event Scale - Revised (IES-R) [ Time Frame: One week and one month follow-up ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: One week and one month follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 5, 2014)
Feedback Questionnaire [ Time Frame: One month follow-up ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Simple Cognitive Task to Reduce the Build-Up of Flashbacks After a Road Traffic Accident
Official Title  ICMJE A Simple Cognitive Task to Reduce the Build-Up of Flashbacks After a Road Traffic Accident: A Randomised Controlled Study in an Emergency Department
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Post-traumatic Stress Disorders
Intervention  ICMJE Behavioral: Simple cognitive task
Study Arms  ICMJE
  • Experimental: Simple cognitive task
    A memory reactivation cue followed by playing the computer game "Tetris"
    Intervention: Behavioral: Simple cognitive task
  • No Intervention: Usual care
    Usual care in the emergency department
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2015)
71
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2014)
80
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02080351
Other Study ID Numbers  ICMJE 12/SC/0485
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Oxford
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Oxford
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Oxford University Hospitals NHS Trust
  • National Institute for Health Research, United Kingdom
  • Medical Research Council Cognition and Brain Sciences Unit
Investigators  ICMJE
Principal Investigator: Lalitha Iyadurai University of Oxford
Principal Investigator: Emily A Holmes MRC Cognition and Brain Sciences Unit, Cambridge
PRS Account University of Oxford
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP