Condition category
Mental and Behavioural Disorders
Date applied
12/10/2008
Date assigned
21/10/2008
Last edited
01/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anthony Bateman

ORCID ID

Contact details

Halliwick Unit
St Ann's Hospital
St Ann's Road
London
N15 3TH
United Kingdom
+44 (0)20 8442 6093
abateman@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of intensive out-patient psychotherapy for treatment of borderline personality disorder: a pragmatic randomised single blind controlled study

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

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

Phase

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

03/03/2003

Overall trial end date

31/07/2012

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

100

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

United Kingdom

Trial participating centre

St Ann's Hospital
London
N15 3TH
United Kingdom

Sponsor information

Organisation

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
London
N15 3TH
United Kingdom
+44 (0)20 8442 6503
research.department@beh-mht.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.beh-mht.nhs.uk/

Funders

Funder type

Research organisation

Funder name

Borderline Personality Disorder Research Foundation (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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: http://www.ncbi.nlm.nih.gov/pubmed/19833787
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23887998
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27577562

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.