Randomised controlled trial of manualised out-patient individual and group therapy for borderline personality disorder

ISRCTN	ISRCTN27660668
DOI	https://doi.org/10.1186/ISRCTN27660668
Protocol serial number	N/A
Sponsor	Barnet, Enfield and Haringey Mental Health Trust (UK)
Funder	Borderline Personality Disorder Research Foundation (USA)

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 of protocol

Not provided at time of registration

Contact information

Dr Anthony Bateman
Scientific

Halliwick Unit
St Ann's Hospital
St Ann's Road
London
N15 3TH
United Kingdom

Phone	+44 (0)20 8442 6093
Email	abateman@nhs.net

Study information

Primary study design	Interventional
Study design	Pragmatic randomised single-blind controlled study, single centre
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness of intensive out-patient psychotherapy for treatment of borderline personality disorder: a pragmatic randomised single blind controlled study
Study objectives	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.
Health condition(s) or problem(s) studied	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(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.
Key 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.
Completion date	31/07/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	03/03/2003
Date of final enrolment	31/07/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St Ann's Hospital

London
N15 3TH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

01/09/2016: Publication reference added.