Pilot study of the efficacy of a psychosocial intervention for frequent parasuicide attempters with personality disturbance
| ISRCTN | ISRCTN28223466 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28223466 |
| Secondary identifying numbers | RDC00388 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 22/02/2008
- 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
Prof Peter Tyrer
Scientific
Scientific
St Mary's Hospital Medical School
Patterson Centre
20 South Wharf Road
London
W2 1PD
United Kingdom
| Phone | +44 (0)20 7886 1648 |
|---|---|
| p.tyrer@ic.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | A pilot study will test the efficacy of a new psychological treatment for patients seen after an episode of deliberate self-harm (parasuicide or attempted suicide). The treatment is based on a self-treatment manual (suicide behaviour prevention manual) developed by us from previous work by Linehan and Davidson on the cognitive treatment of patients with borderline and anti-social personality disorder. Although the previous treatment has been shown to be successful in reducing episodes of deliberate self-harm it is very intensive and not suitable for general use. Our treatment comprises one session of explanation of the manual followed by a maximum of five further sessions of treatment using a psychoeducational and problem solving approach to suicide behaviour. 60 patients aged between 16 and 40 living in Paddington, Marylebone, Chelsea and Kensington will be seen after an episode of deliberate self-harm who have at least one previous suicide attempt in the past year and qualify for personality disturbance (either difficulty or disorder) in one of the flamboyant categories (histrionic, borderline, impulsive, anti-social). They will be randomised to treatment as usual or to the experimental group and treated for up to three months. Assessment of health service costs, suicide intent and acts, mood disturbance and social functioning will be made before randomisation and after six months by an independent research psychologist. If the treatment is found to be successful an application will be made to the MRC for a larger study in a population with less restrictive entrance criteria. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Mental and behavioural disorders: Other mental disorder |
| Intervention | 1. Psychological treatment using a psychoeducational and problem solving approach to suicide behaviour: manual-assisted cognitive-behaviour therapy (MACT) 2. Standard care |
| Intervention type | Other |
| Primary outcome measure | The main outcome measures will be the time of the next parasuicide act (using Linehan's definition of this, which is more minor than an actual suicide attempt). Our expectation is that our experimental treatment will extend this from a mean of three weeks to a mean of three months and this will require a sample size of 30 in each treatment group. |
| Secondary outcome measures | 1. Time to first suicidal act 2. Rate of suicidal acts 3. Change in anxiety and depressive symptoms |
| Overall study start date | 01/01/1996 |
| Completion date | 31/12/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 34 |
| Key inclusion criteria | Efficacy of a new brief manualised form of cognitive behaviour therapy in those with personality disturbance within the flamboyant (cluster B) group. Thirty four patients were enrolled and 32 (18 MACT; 14 TAU) were seen at follow-up. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/01/1996 |
| Date of final enrolment | 31/12/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Mary's Hospital Medical School
London
W2 1PD
United Kingdom
W2 1PD
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London (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 | 01/01/1999 | Yes | No |
