Efficacy of an information booklet in reducing post-traumatic symptoms after road traffic accidents
| ISRCTN | ISRCTN37923456 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37923456 |
| Protocol serial number | SPGS765/AO |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South East (UK) |
- 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
Scientific
University of Oxford
Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Structured interviews and self-reports for the assessment of PTSD symptoms developed by Foa and colleagues |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
University of Oxford
Oxford
OX3 7JX
United Kingdom
OX3 7JX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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
