Welcome
Support Centre
21 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Randomised controlled trial of manualised out-patient individual and group therapy for borderline personality disorder
ISRCTN ISRCTN27660668
DOI 10.1186/ISRCTN27660668
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised controlled trial of manualised out-patient individual and group therapy for borderline personality disorder
Scientific title Effectiveness of intensive out-patient psychotherapy for treatment of borderline personality disorder: a pragmatic randomised single blind controlled study
Acronym N/A
Serial number at source N/A
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.
Lay summary Not provided at time of registration
Ethics approval Barnet, Enfield and Haringey Local Research Ethics Committee formerly Enfield and Haringey Health Authority Local Research Ethics Committee, June 1999/January 2007 (ref: 658). Ethical approval for 5 year follow-up applied for to Barnet, Enfield and Haringey Local Research Ethics Committee.
Study design Pragmatic randomised single blind controlled study, single centre
Countries of recruitment United Kingdom
Disease/condition/study domain Borderline personality disorder
Participants - 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
Participants - 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
Anticipated start date 03/03/2003
Anticipated end date 31/07/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 100
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding Borderline Personality Disorder Research Foundation (USA)
Trial website
Publications 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19833787
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23887998
Contact name Dr  Anthony  Bateman
  Address Halliwick Unit
St Ann's Hospital
St Ann's Road
  City/town London
  Zip/Postcode N15 3TH
  Country United Kingdom
  Tel +44 (0)20 8442 6093
  Fax +44 (0)20 8442 6545
  Email abateman@nhs.net
Sponsor Barnet, Enfield and Haringey Mental Health Trust (UK)
  Address c/o Dr Gerry Leavey/Dr Eric Sabine
Research Department
St Ann's Hospital
St Ann's Road
  City/town London
  Zip/Postcode N15 3TH
  Country United Kingdom
  Tel +44 (0)20 8442 6503
  Fax +44 (0)20 8442 6503
  Email research.department@beh-mht.nhs.uk
  Sponsor website: http://www.beh-mht.nhs.uk/
Date applied 12/10/2008
Last edited 19/03/2014
Date ISRCTN assigned 21/10/2008
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.