Efficacy of an information booklet in reducing post-traumatic symptoms after road traffic accidents

ISRCTN	ISRCTN37923456
DOI	https://doi.org/10.1186/ISRCTN37923456
Secondary identifying numbers	SPGS765/AO

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 05/07/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Richard Mayou
Scientific

University of Oxford
Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Efficacy of an information booklet in reducing post-traumatic symptoms after road traffic accidents
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/1998
Completion date	01/05/2002

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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.
Key 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
Date of first enrolment	01/05/1998
Date of final enrolment	01/05/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Oxford

Oxford
OX3 7JX
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South East (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2000		Yes	No

Editorial Notes

05/07/2018: Internal review