|
ISRCTN
|
ISRCTN37923456
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Efficacy of an information booklet in reducing post-traumatic symptoms after road traffic accidents
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
SPGS765/AO
|
|
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.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Not applicable
|
|
Participants - 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.
|
|
Participants - 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
|
|
Anticipated start date
|
01/05/1998
|
|
Anticipated end date
|
01/05/2002
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
NHS Executive South East (UK)
|
|
Trial website
|
|
|
Publications
|
2000 3 year follow up results in http://www.ncbi.nlm.nih.gov/pubmed/10974967
|
|
Contact name
|
Prof
Richard
Mayou
|
|
Address
|
University of Oxford
Department of Psychiatry
Warneford Hospital
|
|
City/town
|
Oxford
|
|
Zip/Postcode
|
OX3 7JX
|
|
Country
|
United Kingdom
|
|
Sponsor
|
NHS R&D Regional Programme Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
23/01/2004
|
|
Last edited
|
03/12/2008
|
|
Date ISRCTN assigned
|
23/01/2004
|
