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

Post-traumatic Stress Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080351
• Other study ID #: 12/SC/0485
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: May 29, 2015
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: NHS Health Research AuthorityUnited Kingdom: Oxford University Hospitals NHS Trust
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Post-traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Simple cognitive task

Locations

Country	Name	City	State
United Kingdom	Emergency Department, John Radcliffe Hospital	Oxford	Oxfordshire

Sponsors (4)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feedback Questionnaire		One month follow-up	No
Primary	Number of flashbacks recorded by participants in a Flashback Record in the week after the accident		Within one week after the accident (Flashback Record will be returned to a researcher at one week follow-up)	No
Secondary	Post-traumatic Stress Diagnostic Scale (PDS)		One week and one month follow-up	No
Secondary	Impact of Event Scale - Revised (IES-R)		One week and one month follow-up	No
Secondary	Hospital Anxiety and Depression Scale (HADS)		One week and one month follow-up	No