BOSCOT : A Randomised Controlled Trial of Cognitive Behavioural Therapy in Borderline Personality Disorder - Full Text View

Sponsors and Collaborators:	University of Aberdeen Wellcome Trust University of Glasgow University of London University of York
Information provided by:	University of Aberdeen
ClinicalTrials.gov Identifier:	NCT00538135

Purpose

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.

Condition	Intervention	Phase
Borderline Personality Disorder	Behavioral: Cognitive Behavioural Therapy Other: Treatment as usual	Phase III

MedlinePlus related topics: Personality Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by University of Aberdeen:

Primary Outcome Measures:

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. [ Time Frame: At both 12 and 24 months post randomisation. ]

Secondary Outcome Measures:

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) [ Time Frame: 6, 12, 18 and 24 months post randomisation ]

Enrollment:	106
Study Start Date:	February 2002
Study Completion Date:	March 2005

Arms	Assigned Interventions
1: Experimental Cognitive Behaviour Therapy plus Treatment as Usual (CBT plus TAU) for borderline personality disorder. CBT is a structured, time limited, psycho-social intervention developed to treat 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. Thirty sessions of CBT over one year, 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	Behavioral: Cognitive Behavioural Therapy Other: Treatment as usual Standard National Health Service treatment as usual for borderline personality disorder
2: Active Comparator Treatment as Usual. All participants received the standard treatment (TAU) they would have received if the trial had not been in place. Although standard treatment may vary across the three sites, and depend on the specific problems of the individual participant, 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.	Other: Treatment as usual Standard National Health Service treatment as usual for borderline personality disorder

Arms

Assigned Interventions

1: Experimental

Cognitive Behaviour Therapy plus Treatment as Usual (CBT plus TAU) for borderline personality disorder.

CBT is a structured, time limited, psycho-social intervention developed to treat 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. Thirty sessions of CBT over one year, 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

Behavioral: Cognitive Behavioural Therapy Other: Treatment as usual

Standard National Health Service treatment as usual for borderline personality disorder

2: Active Comparator

Treatment as Usual.

All participants received the standard treatment (TAU) they would have received if the trial had not been in place. Although standard treatment may vary across the three sites, and depend on the specific problems of the individual participant, 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.

Other: Treatment as usual

Standard National Health Service treatment as usual for borderline personality disorder

Detailed 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:

Aged between 18 and 65.
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)
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.
Able to give informed consent.

Exclusion criteria were as follows:

Currently receiving in-patient treatment for a mental state disorder,
Currently receiving a systematic psychological therapy or specialist service, particularly psychodynamic psychotherapy,
Insufficient knowledge of English to enable them to be assessed adequately and to understand the treatment approach,
Temporarily resident in the area,
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).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aged between 18 and 65.
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)
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.
Able to give informed consent.

Exclusion Criteria:

Currently receiving in-patient treatment for a mental state disorder,
Currently receiving a systematic psychological therapy or specialist service, particularly psychodynamic psychotherapy,
Insufficient knowledge of English to enable them to be assessed adequately and to understand the treatment approach,
Temporarily resident in the area,
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538135

Locations

United Kingdom, Strathclyde
Psychological Medicine
Glasgow, Strathclyde, United Kingdom, G12 0XH

Sponsors and Collaborators

University of Aberdeen

Wellcome Trust

University of Glasgow

University of London

University of York

Investigators

Principal Investigator:

Kate Davidson, PhD

University of Glasgow

More Information

Study ID Numbers:	064027/Z/01/Z
Study First Received:	September 29, 2007
Last Updated:	September 29, 2007
ClinicalTrials.gov Identifier:	NCT00538135
Health Authority:	United Kingdom: Research Ethics Committee; United Kingdom: National Health Service

Keywords provided by University of Aberdeen:

randomised controlled trial
borderline personality disorder
cognitive behavioural therapy
treatment as usual

Study placed in the following topic categories:

Mental Disorders
Borderline Personality Disorder
Personality Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009