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History of Changes for Study: NCT02080351
A Simple Cognitive Task to Reduce the Build-Up of Flashbacks After a Road Traffic Accident (SCARTA)
Latest version (submitted May 29, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 5, 2014 None (earliest Version on record)
2 March 10, 2014 Outcome Measures, Eligibility and Study Status
3 December 2, 2014 Study Status and Study Design
4 January 23, 2015 Recruitment Status, Study Status, Contacts/Locations and Sponsor/Collaborators
5 May 29, 2015 Recruitment Status, Study Status and Study Design
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Study NCT02080351
Submitted Date:  March 5, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 12/SC/0485
Brief Title: A Simple Cognitive Task to Reduce the Build-Up of Flashbacks After a Road Traffic Accident (SCARTA)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2014
Overall Status: Recruiting
Study Start: March 2014
Primary Completion: December 2014 [Anticipated]
Study Completion: December 2014 [Anticipated]
First Submitted: March 4, 2014
First Submitted that
Met QC Criteria:
March 5, 2014
First Posted: March 6, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 5, 2014
Last Update Posted: March 6, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Oxford
Responsible Party: Sponsor
Collaborators: Oxford University Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Post-traumatic Stress Disorders
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Flashback Record
[ Time Frame: 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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 DSM-IV criterion A1 for PTSD ("experienced, witnessed, or confronted with actual or threatened death or serious injury)
  • Can be seen in the ED within 6 hours of leaving the scene of the accident
  • Report memory of the accident
  • Fluent in written and spoken English
  • Alert and orientated, 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
Open or close this module Contacts/Locations
Central Contact Person: Lalitha Iyadurai, ClinPsyD
Telephone: +44 1865 223923
Email: lalitha.iyadurai@psych.ox.ac.uk
Central Contact Backup: Emily A Holmes, PhD
Telephone: +44 1223 355294
Email: emily.holmes@mrc-cbu.cam.ac.uk
Study Officials: Lalitha Iyadurai
Principal Investigator
University of Oxford
Emily A Holmes
Principal Investigator
MRC Cognition and Brain Sciences Unit, Cambridge
Locations: United Kingdom, Oxfordshire
Emergency Department, John Radcliffe Hospital
[Recruiting]
Oxford, Oxfordshire, United Kingdom, OX3 9DU
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