Condition category
Not Applicable
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Richard Mayou

ORCID ID

Contact details

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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes