Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SPGS765/AO
Study information
Scientific title
Acronym
Study hypothesis
1. To test whether a trauma booklet given out during a single session of cognitive behavioural advice is more effective in reducing PTSD symptoms after a road traffic accident than no intervention (wait list) in the short-term (immediately afterwards) and in the long-term (up to one year after the accident).
2. To compare the therapeutic effect of the booklet with that of specialist cognitive behavioural treatment CBT). What proportion of the CBT effect can be achieved by giving the booklet on its own?
3. To determine the effectiveness of postal follow-up of trauma service attenders and publicity to general practitioners in identifying road accident victims with distressing and disabling PTSD at 2 to 3 months.
4. Cost-effective delivery of simple self-help and specialist treatment for the large numbers of trauma victims who suffer distressing and disabling post-traumatic symptoms.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Not applicable
Intervention
1. Trauma booklet
2. Cognitive behavioural treatment (CBT) including the trauma booklet.
3. Wait list
The booklet and CBT will be given at 3 months after the accident.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Structured interviews and self-reports for the assessment of PTSD symptoms developed by Foa and colleagues
2. Beck depression Inventory
3. Beck anxiety Inventory
4. Measures of travel anxiety and avoidance developed in previous Oxford research
5. We will also report medical consultation and effects on quality of everyday activities
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/1998
Overall trial end date
01/05/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Possible subjects will be identified at the John Radcliffe Hospital, Oxford and the Northampton General Hospital.
Patients will be contacted within 2 months of their road traffic accident and asked to fill out the post-traumatic stress disorder (PTSD) Diagnostic Scale (PTSD, Foa 1996) to assess PTSD. Subjects will be eligible if they suffer from PTSD at 2 months after the accident and have a minimum severity of symptoms of 20 on the post-traumatic stress diagnostic scale (PDS). This cut-off was chosen based on RM's prospective study. Patients meeting this criterion have a low probability of spontaneous remission (<30%). Approximately 14% of the patients contacted will meet this criterion.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Include brain damage, spinal cord injuries, chronic major psychiatric disorder (schizophrenia, manic-depressive disorder, alcohol or drug dependence) or severe current psychiatric problems which are thought to require immediate intervention
Recruitment start date
01/05/1998
Recruitment end date
01/05/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford
Oxford
OX3 7JX
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2000 3 year follow up results in http://www.ncbi.nlm.nih.gov/pubmed/10974967
Publication citations
-
Mayou RA, Ehlers A, Hobbs M, Psychological debriefing for road traffic accident victims. Three-year follow-up of a randomised controlled trial., Br J Psychiatry, 2000, 176, 589-593.