Prevention Of Parasuicide by Manual Assisted Cognitive-behavioural Therapy
| ISRCTN | ISRCTN97313434 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97313434 |
| Secondary identifying numbers | G9702283 |
- Submission date
- 23/10/2000
- Registration date
- 23/10/2000
- Last edited
- 12/09/2007
- 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
Professor Peter Tyrer
Scientific
Scientific
Academic Department of Psychiatry
Imperial College School of Medicine
Paterson Centre
20 South Wharf Road
London
W2 1PD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | POPMACT |
| Study objectives | To determine whether manual assisted cognitive behaviour therapy (MACT) is more effective than treatment as usual (TAU) in reducing the rate of episodes of deliberate self harm over a 12 month period |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Parasuicide |
| Intervention | 1. Manual assisted cognitive behaviour therapy (MACT) 2. Treatment as usual (TAU) |
| Intervention type | Other |
| Primary outcome measure | Rate of episodes of deliberate self-harm (using the Parasuicidal Acts Scale of Linehan) over the 12 month period |
| Secondary outcome measures | 1. Time to next episode of deliberate self-harm 2. Improvement in clinical symptoms (anxiety and depression) using the Hospital Anxiety and Depression Scale (HADS) 3. Change in social function (using the Social Functioning Questionnaire) 4. Cost of care |
| Overall study start date | 01/12/1997 |
| Completion date | 01/10/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 500 |
| Key inclusion criteria | Patients presenting to the psychiatric services at any of five centres: 1. Southern General Hospital, Victoria Hospital and Stobhill Hospital in Glasgow 2. Royal Edinburgh Hospital, Edinburgh 3. Queen's Medical Centre, Nottingham 4. Chelsea and Westminster Hospital and St Mary's Hospital, West London 5. King's College Hospital, South London and Maidstone General Hospital, Kent Patients will be included if they satisfy the following criteria: 1. Aged between 16 and 65 2. Have presented to an Accident & Emergency department after an episode of deliberate self-harm 3. They have had at least one other episode of deliberate self-harm previously 4. They give informed consent Recruitment will take place over 20 months and randomisation of each patient will take place after all baseline assessments have been completed by the research assessor |
| Key exclusion criteria | 1. Patients who do not have sufficient knowledge of English to enable them to be assessed adequately and to understand the treatment manual 2. Patients who are only temporary residents in the area concerned (e.g. foreign visitors, tertiary referrals with a permanent address elsewhere) who are unlikely to be available for follow-up (This does not necessarily include many people who are homeless but who come from the geographical area concerned; this group is at high risk of repeated episodes and constitutes around one in six of all parasuicide episodes and many will be included if they have established links in the geographical area) 3. Those with a diagnosis within the organic (F00 to F09), alcohol/drug dependence (F10 to F19), schizophrenia group (F20 to F29) or bipolar affective disorder (F31) (using the International Classification of Diseases [ICD-10] coding) 4. People who require psychiatric hospitalisation after their self-harm episode. Recruitment will take place over 20 months and randomisation of each patient will take place after all base-line assessments have been completed by the research assessor |
| Date of first enrolment | 01/12/1997 |
| Date of final enrolment | 01/10/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Department of Psychiatry
London
W2 1PD
United Kingdom
W2 1PD
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
UK Medical Research Council
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 | 01/02/2004 | Yes | No |
