Condition category
Mental and Behavioural Disorders
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
26/11/2012
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

Prof Kate Davidson

ORCID ID

Contact details

Glasgow Institute of Psychosocial Interventions
Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
+44 (0)141 211 3900
k.davidson@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00538135

Protocol/serial number

064027; 01/27

Study information

Scientific title

A randomised controlled trial of cognitive therapy plus treatment as usual versus treatment as usual in the treatment of borderline personality disorder

Acronym

BOSCOT

Study hypothesis

We anticipate that the addition of cognitive behavioural therapy to treatment as usual (CBT plus TAU) in participants with borderline personality disorder will decrease the number of participants with in-patient psychiatric hospitalisations or accident and emergency room contact or suicidal acts over twelve months treatment and twelve months follow-up, compared with treatment as usual (TAU). We also anticipate that CBT plus TAU will lead to superior improvement in quality of life, social, cognitive and mental health functioning compared to TAU alone.

Ethics approval

Research Ethics Committee of Greater Glasgow Primary Care NHS Trust gave approval on the 15th August 2001

Study design

Multicentre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Borderline personality disorder

Intervention

Those participants who met the inclusion criteria and who agreed to give written informed consent to take part in the study then completed baseline assessments and were randomly allocated to either one of two active treatment groups namely, TAU, or CBT plus TAU.

Interventions:
CBT is a structured, time limited, psycho-social intervention which has been developed to treat those with Cluster B personality disorder. Patients are encouraged to engage in treatment through a formulation of their problems within a cognitive framework.

Interventions focus on the patient's beliefs and behaviour that impair social and adaptive functioning. Up to 30 sessions (minimum 15) of treatment, each lasting up to one hour, are required to work on long-standing problems and develop new ways of thinking and behaving. Priority is given to behaviours that cause harm to self or others. In addition, participants received the usual treatment they would have received if the trial had not been in place.

Treatment as usual:
All participants received the standard treatment (TAU) they would have received if the trial had not been in place. It was thought that all participants would be in contact with mental health services and would have some contact with Accident and Emergency services for repeated self-harm episodes. TAU will be documented carefully after each patient exits the trial.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Acts of deliberate self-harm in the twelve months prior to baseline, and the twelve months following baseline. Trial participants are being assessed on all measures at six monthly intervals.

Secondary outcome measures

1. Brief Symptom Inventory
2. Beck Depression Inventory-II
3. State-Trait Anxiety Inventory
4. Social Functioning Questionnaire
5. Inventory of Interpersonal Problems
6. Schema Questionnaire
7. The Euro-Qol quality of life questionnaire
8. Client Service Receipt Inventory (CSRI)

Trial participants are being assessed on all measures at six monthly intervals, except for the Schema Questionnaire and the Brief Symptom Inventory, where both are assessed at end of treatment and end of follow-up only.

Overall trial start date

01/02/2002

Overall trial end date

01/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 65, either sex
2. Met criteria for at least five items of the borderline personality disorder using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) Axis II Personality Disorders (SCID -II)
3. Had received either in-patient psychiatric services or an assessment at Accident and Emergency services or an episode of deliberate self-harm (either suicidal act or self-mutilation) in the previous 12 months
4. Able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

106

Participant exclusion criteria

1. Currently receiving in-patient treatment for a mental state disorder
2. Currently receiving a systematic psychological therapy or specialist service, particularly psychodynamic psychotherapy
3. Insufficient knowledge of English to enable them to be assessed adequately and to understand the treatment approach
4. Temporarily resident in the area
5. The existence of an organic illness, mental impairment, alcohol or drug dependence, schizophrenia or bipolar affective disorder, as assessed by SCID I, /P (W/Psychotic Screen) (version two)

Recruitment start date

01/02/2002

Recruitment end date

01/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glasgow Institute of Psychosocial Interventions
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

University of Glasgow (UK)

Sponsor details

Research & Enterprise
10 The Square
Glasgow
G12 8QQ
United Kingdom
+44 (0)141 330 5005
R-E@gla.ac.uk

Sponsor type

University/education

Website

http://www.gla.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 064027)

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

1. Protocol in http://www.ncbi.nlm.nih.gov/pubmed/17032157
2. 2006 effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/17032158
3. 2006 cost-effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/17032159
4. 2010 six year follow up results in http://www.ncbi.nlm.nih.gov/pubmed/21119151

Publication citations

  1. Protocol

    Davidson K, Tyrer P, Gumley A, Tata P, Norrie J, Palmer S, Millar H, Drummond L, Seivewright H, Murray H, Macaulay F, A randomized controlled trial of cognitive behavior therapy for borderline personality disorder: rationale for trial, method, and description of sample., J. Pers. Disord., 2006, 20, 5, 431-449, doi: 10.1521/pedi.2006.20.5.431.

  2. Effectiveness results

    Davidson K, Norrie J, Tyrer P, Gumley A, Tata P, Murray H, Palmer S, The effectiveness of cognitive behavior therapy for borderline personality disorder: results from the borderline personality disorder study of cognitive therapy (BOSCOT) trial., J. Pers. Disord., 2006, 20, 5, 450-465, doi: 10.1521/pedi.2006.20.5.450.

  3. Six year follow up results

    Davidson KM, Tyrer P, Norrie J, Palmer SJ, Tyrer H, Cognitive therapy v. usual treatment for borderline personality disorder: prospective 6-year follow-up., Br J Psychiatry, 2010, 197, 6, 456-462, doi: 10.1192/bjp.bp.109.074286.

  4. Palmer S, Davidson K, Tyrer P, Gumley A, Tata P, Norrie J, Murray H, Seivewright H, The cost-effectiveness of cognitive behavior therapy for borderline personality disorder: results from the BOSCOT trial., J. Pers. Disord., 2006, 20, 5, 466-481, doi: 10.1521/pedi.2006.20.5.466.

Additional files

Editorial Notes