search
Back to results

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

Primary Purpose

Post-traumatic Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Simple cognitive task
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-traumatic Stress Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emergency Department, John Radcliffe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Simple cognitive task

Usual care

Arm Description

A memory reactivation cue followed by playing the computer game "Tetris"

Usual care in the emergency department

Outcomes

Primary Outcome Measures

Number of flashbacks recorded by participants in a Flashback Record in the week after the accident

Secondary Outcome Measures

Post-traumatic Stress Diagnostic Scale (PDS)
Impact of Event Scale - Revised (IES-R)
Hospital Anxiety and Depression Scale (HADS)

Full Information

First Posted
March 4, 2014
Last Updated
May 29, 2015
Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust, National Institute for Health Research, United Kingdom, Medical Research Council Cognition and Brain Sciences Unit
search

1. Study Identification

Unique Protocol Identification Number
NCT02080351
Brief Title
A Simple Cognitive Task to Reduce the Build-Up of Flashbacks After a Road Traffic Accident
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust, National Institute for Health Research, United Kingdom, Medical Research Council Cognition and Brain Sciences Unit

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simple cognitive task
Arm Type
Experimental
Arm Description
A memory reactivation cue followed by playing the computer game "Tetris"
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care in the emergency department
Intervention Type
Behavioral
Intervention Name(s)
Simple cognitive task
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Post-traumatic Stress Diagnostic Scale (PDS)
Time Frame
One week and one month follow-up
Title
Impact of Event Scale - Revised (IES-R)
Time Frame
One week and one month follow-up
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
One week and one month follow-up
Other Pre-specified Outcome Measures:
Title
Feedback Questionnaire
Time Frame
One month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lalitha Iyadurai
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emily A Holmes
Organizational Affiliation
MRC Cognition and Brain Sciences Unit, Cambridge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Department, John Radcliffe Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs