A randomised controlled trial to assess the effectiveness of giving self-help information to people with symptoms of acute stress disorder following a traumatic injury.
| ISRCTN | ISRCTN25835525 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25835525 |
| Secondary identifying numbers | N0071137440 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 15/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Catherine Scholes
Scientific
Scientific
Clinical Psychology
114 St Anthony Road
Sheffield
S10 1SG
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 | |
| Study objectives | The aims of the study are: 1. To assess the relationship between giving self-help information to traumatic injury patients with symptoms of Acute Stress Disorder (with or without acute dissociation) and subsequent symptom severity. 2. To identify potential predictors of those patients who will benefit from self-help information. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Acute stress disorders |
| Intervention | The study will employ a between-groups repeated measures design to assess psychological sequelae and quality of life for individuals experiencing symptoms of Acute Stress Disorder (ASD) following attendance at Accident and Emergency after a traumatic event. There will be three different groups: Group 1- the Information group - will consist of patients with symptoms of Acute Stress Disorder who receive the self-help booklet within one month of their traumatic injury; Group 2 - the Waiting List Control group - will consist of patients with symptoms of Acute Stress Disorder who receive the self-help booklet at the end of the study period; Group 3 - the non-ASD Control Group- will consist of patients without symptoms of Acute Stress Disorder who receive the self-help booklet at the end of the study period. These groups will be assessed at three points in time (within one month of the trauma, three months posttrauma and six months posttrauma). |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2003 |
| Completion date | 30/09/2004 |
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 | 1. Two Acute Stress Disorder groups 1.1 Accident and Emergency patients involved in road traffic accidents, assaults and occupational injuries of at least moderate severity between the months of July 2003 and January 2004. 1.2 meet the cut-off criteria for Acute Stress Disorder symptomatology (with or without dissociation) 1.3 consent to participate in the study 1.4 between the ages of 18 and 65. 2. Non-Acute Stress Disorder control group 2.1 patients who have had an accident of at least moderate severity 2.2 do not meet the cut-off criteria for Acute Stress Disorder symptomatology |
| Key exclusion criteria | 1. suffering from a psychotic illness 2. learning disability 3. head injury 4. illiterate or do not speak English |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 30/09/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Psychology
Sheffield
S10 1SG
United Kingdom
S10 1SG
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Research council
Sheffield Health and Social Research Consortium (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 | 01/11/2007 | Yes | No |
