Randomised controlled trial of manualised out-patient individual and group therapy for borderline personality disorder
| ISRCTN | ISRCTN27660668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27660668 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/10/2008
- Registration date
- 21/10/2008
- Last edited
- 01/09/2016
- 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
Not provided at time of registration
Contact information
Dr Anthony Bateman
Scientific
Scientific
Halliwick Unit
St Ann's Hospital
St Ann's Road
London
N15 3TH
United Kingdom
| Phone | +44 (0)20 8442 6093 |
|---|---|
| abateman@nhs.net |
Study information
| Study design | Pragmatic randomised single-blind controlled study, single centre |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effectiveness of intensive out-patient psychotherapy for treatment of borderline personality disorder: a pragmatic randomised single blind controlled study |
| Study hypothesis | Mentalisation based treatment (MBT) when delivered in an out-patient NHS clinical service by mental health professionals who receive limited training is a more effective treatment for suicidal and self-harming patients with borderline personality disorder (BPD) than current best practice. Structured and coherent practice is considered to be a component of effective practice when treating patients with BPD. To control for the non-specific effects of a structured treatment the comparison group will receive a protocol-driven manualised treatment with structured clinical management representing best current clinical practice with equivalent supervision. |
| Ethics approval(s) | Barnet, Enfield and Haringey Local Research Ethics Committee, formerly Enfield and Haringey Health Authority Local Research Ethics Committee, June 1999/January 2007, ref: 658. Ethics approval for 5-year follow-up applied for to Barnet, Enfield and Haringey Local Research Ethics Committee. |
| Condition | Borderline personality disorder |
| Intervention | Mentalisation based therapy (MBT) compared with structured clinical management (SCM): 1. MBT consists of mentalising focus work in an individual session and a group session once per week 2. SCM consists of advocacy work, problem solving in an individual session and a group session once per week The duration of treatment is 18 months and the follow-up is over a 5-year period. |
| Intervention type | Other |
| Primary outcome measure | The presence or absence or frequency in a 6-month period of severe parasuicidal behaviour as indicated by: 1. Suicide attempt 2. Life-threatening self-harm 3. Hospital admission. Hospital is included because in general mental health services patients with BPD are primarily offered in-patient care in anticipation of suicide attempts and during episodes of severe self-harm. |
| Secondary outcome measures | 1. Psychiatric symptoms 2. Social and interpersonal function Measured at baseline and at 6-monthly intervals to the end of treatment and then yearly over the follow-up period. |
| Overall study start date | 03/03/2003 |
| Overall study end date | 31/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. Diagnosis of BPD2 2. Suicide attempt or episode of severe self-harm within last six months 3. Aged 18 - 65 years, either sex |
| Participant exclusion criteria | 1. Currently in a long term psychotherapeutic treatment 2. Meet Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for psychotic disorder or bipolar I disorder 3. Have opiate dependence with physiological dependence requiring specialist treatment 4. Have mental impairment or evidence of organic brain disorder |
| Recruitment start date | 03/03/2003 |
| Recruitment end date | 31/07/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Ann's Hospital
London
N15 3TH
United Kingdom
N15 3TH
United Kingdom
Sponsor information
Barnet, Enfield and Haringey Mental Health Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Gerry Leavey/Dr Eric Sabine
Research Department
St Ann's Hospital
St Ann's Road
London
N15 3TH
England
United Kingdom
| Phone | +44 (0)20 8442 6503 |
|---|---|
| research.department@beh-mht.nhs.uk | |
| Website | http://www.beh-mht.nhs.uk/ |
"ROR" |
https://ror.org/00d2v4e22 |
Funders
Funder type
Research organisation
Borderline Personality Disorder Research Foundation (USA)
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 | 01/12/2009 | Yes | No | |
| Results article | results | 01/09/2013 | Yes | No | |
| Results article | results | 30/08/2016 | Yes | No |
Editorial Notes
01/09/2016: Publication reference added.
