Post-traumatic Stress DisordersSCARTANCT02080351
A Simple Cognitive Task to Reduce the Build-Up of Flashbacks After a Road Traffic Accident
A study testing Simple cognitive task in people with Post-traumatic Stress Disorders, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorders
- What is being tested?
- Simple cognitive task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Loss of consciousness of > 5 minutes
- Current intoxication
- Report a history of severe mental illness
- Current substance abuse or neurological condition
- Currently suicidal
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Emergency Department, John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
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
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.
- Conditions
- Post-traumatic Stress Disorders
- Being tested
- Simple cognitive task
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple cognitive taskBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Simple cognitive task | Experimental | A memory reactivation cue followed by playing the computer game "Tetris" Receives: Behavioral: Simple cognitive task |
| Usual care | No intervention | Usual care in the emergency department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of flashbacks recorded by participants in a Flashback Record in the week after the accident
Measured: Within one week after the accident (Flashback Record will be returned to a researcher at one week follow-up)
Secondary outcomes (3)
Post-traumatic Stress Diagnostic Scale (PDS)
Measured: One week and one month follow-up
Impact of Event Scale - Revised (IES-R)
Measured: One week and one month follow-up
Hospital Anxiety and Depression Scale (HADS)
Measured: One week and one month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, National Institute for Health Research, United Kingdom, Medical Research Council Cognition and Brain Sciences Unit
- Responsible party
- Sponsor
- Investigators
- Lalitha Iyadurai, Principal investigator, University of OxfordEmily A Holmes, Principal investigator, MRC Cognition and Brain Sciences Unit, Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080351
- Sponsor's protocol ID
- 12/SC/0485
- Acronym
- SCARTA
- Status last verified
- May 2015
- First submitted
- 4 Mar 2014
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02080351
- Acronym / sponsor ID
- SCARTA / 12/SC/0485
- Conditions
- Post-traumatic Stress Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, National Institute for Health Research, United Kingdom, Medical Research Council Cognition and Brain Sciences Unit
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple cognitive task | Experimental | Behavioral: Simple cognitive taskA memory reactivation cue followed by playing the computer game "Tetris" |
| Usual care | No intervention | –Usual care in the emergency department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- Loss of consciousness of > 5 minutes
- Current intoxication
- Report a history of severe mental illness
- Current substance abuse or neurological condition
- Currently suicidal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple cognitive task | Behavioural | Simple cognitive task |
Primary outcome
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)
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lalitha Iyadurai principal investigator
University of Oxford
Emily A Holmes principal investigator
MRC Cognition and Brain Sciences Unit, Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple cognitive task in people with Post-traumatic Stress Disorders, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015; AzTrials last refreshed its copy on 29 Oct 2026.