Clinical trial NCT02080351: A Simple Cognitive Task to Reduce the Build-Up of Flashbacks After a Road Traffic Accident
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
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorders
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
name: National Institute for Health Research, United Kingdom
name: Medical Research Council Cognition and Brain Sciences Unit
First posted: 2014-03-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of flashbacks recorded by participants in a Flashback Record in the week after the accident
timeFrame: Within one week after the accident (Flashback Record will be returned to a researcher at one week follow-up)
Secondary outcomes:
measure: Post-traumatic Stress Diagnostic Scale (PDS)
timeFrame: One week and one month follow-up
measure: Impact of Event Scale - Revised (IES-R)
timeFrame: One week and one month follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: One week and one month follow-up
Other outcomes:
measure: Feedback Questionnaire
timeFrame: One month follow-up
Locations:
city: Oxford
country: United Kingdom
facility: Emergency Department, John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Lalitha Iyadurai
role: PRINCIPAL_INVESTIGATOR
affiliation: MRC Cognition and Brain Sciences Unit, Cambridge
name: Emily A Holmes
role: PRINCIPAL_INVESTIGATOR
References: