BOSCOT : A Randomised Controlled Trial of Cognitive Behavioural Therapy in Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

— BOSCOT  

Official title:

BOSCOT: A Randomised Control Trial of Cognitive Behavioural Therapy Plus Treatment as Usual Versus Treatment as Usual in the Treatment of Borderline Personality Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538135
• Other study ID #: 064027/Z/01/Z
• Status: Completed
• Phase: Phase 3
• First received: September 29, 2007
• Last updated: September 29, 2007
• Start date: February 2002
• Est. completion date: March 2005

Study information

• Verified date: September 2007
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

The aim of the study was to investigate if the addition of cognitive behavioural therapy to treatment as usual (CBT plus TAU) in participants with borderline personality disorder would decrease the number of participants with emergency (i.e. unplanned) psychiatric or accident and emergency room contact or episode of deliberate self-harm over twelve months treatment and twelve months follow-up, compared with treatment as usual (TAU). The study also examined whether CBT plus TAU would lead to superior improvement in quality of life, social, cognitive and mental health functioning than TAU alone.

Description:

The trial is being carried out in three centres in the UK: Glasgow, London and Ayrshire (Ayrshire and Arran). Treatment as Usual (TAU) therefore reflected what is likely to be available in the UK.

Patients were eligible if they satisfied the following criteria:

1. Aged between 18 and 65.

2. Met criteria for at least 5 items of the borderline personality disorder using the Structured Clinical Interview for DSM IV Axis II Personality Disorders (SCID -II)(First, Gibbon, Spitzer, Williams & Benjamin, 1997)

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.

Exclusion criteria were as follows:

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 2) (First, Spitzer, Gibbon, Williams, 1996).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Aged between 18 and 65.

2. Met criteria for at least 5 items of the borderline personality disorder using the Structured Clinical Interview for DSM IV Axis II Personality Disorders (SCID -II)(First, Gibbon, Spitzer, Williams & Benjamin, 1997)

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.

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 2) (First, Spitzer, Gibbon, Williams, 1996).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• Cognitive Behavioural Therapy

Other:
• Treatment as usual
Standard National Health Service treatment as usual for borderline personality disorder

Locations

Country	Name	City	State
United Kingdom	Psychological Medicine	Glasgow	Strathclyde

Sponsors (5)

Lead Sponsor	Collaborator
University of Aberdeen	University of Glasgow, University of London, University of York, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the composite outcome of the number of in-patient psychiatric hospitalisations, the number of A& E contacts, and the number of suicidal acts.		At both 12 and 24 months post randomisation.
Secondary	Secondary outcome measures include the Brief Symptom Inventory, Beck Depression Inventory-II, State-Trait Anxiety Inventory, Social Functioning Questionnaire, Inventory of Interpersonal Problems, Schema Questionnaire (Young), Euro-Qol (EQ-5D)		6, 12, 18 and 24 months post randomisation