Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Anthony Bateman


Contact details

Halliwick Unit
St Ann's Hospital
St Ann's Road
N15 3TH
United Kingdom
+44 (0)20 8442 6093

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

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

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.

Study design

Pragmatic randomised single-blind controlled study, single centre

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Borderline personality disorder


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



Not Specified

Drug names

Primary outcome measures

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 trial start date


Overall trial end date


Reason abandoned


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 type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

St Ann's Hospital
N15 3TH
United Kingdom

Sponsor information


Barnet, Enfield and Haringey Mental Health Trust (UK)

Sponsor details

c/o Dr Gerry Leavey/Dr Eric Sabine
Research Department
St Ann's Hospital
St Ann's Road
N15 3TH
United Kingdom
+44 (0)20 8442 6503

Sponsor type

Hospital/treatment centre



Funder type

Research organisation

Funder name

Borderline Personality Disorder Research Foundation (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in:
2013 results in:
2016 results in:

Publication citations

  1. Results

    Bateman A, Fonagy P, Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder., Am J Psychiatry, 2009, 166, 12, 1355-1364, doi: 10.1176/appi.ajp.2009.09040539.

  2. Results

    Bateman A, Fonagy P, Impact of clinical severity on outcomes of mentalisation-based treatment for borderline personality disorder., Br J Psychiatry, 2013, 203, 3, 221-227, doi: 10.1192/bjp.bp.112.121129.

  3. Results

    Bateman A, O'Connell J, Lorenzini N, Gardner T, Fonagy P, A randomised controlled trial of mentalization-based treatment versus structured clinical management for patients with comorbid borderline personality disorder and antisocial personality disorder, BMC Psychiatry, 2016, 16, 304, doi: 10.1186/s12888-016-1000-9.

Additional files

Editorial Notes

01/09/2016: Publication reference added.