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

NCT ID: NCT00538135

Last Updated: 2007-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2005-03-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Borderline Personality Disorder

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

Treatment as usual

Intervention Type OTHER

Standard National Health Service treatment as usual for borderline personality disorder

2

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.

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Standard National Health Service treatment as usual for borderline personality disorder

Interventions

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Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

Treatment as usual

Standard National Health Service treatment as usual for borderline personality disorder

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wellcome Trust

OTHER

Sponsor Role collaborator

University of Glasgow

OTHER

Sponsor Role collaborator

University of London

OTHER

Sponsor Role collaborator

University of York

OTHER

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role lead

Principal Investigators

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Kate Davidson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

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Psychological Medicine

Glasgow, Strathclyde, United Kingdom

Site Status

Countries

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United Kingdom

References

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Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

Reference Type DERIVED
PMID: 32368793 (View on PubMed)

Other Identifiers

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064027/Z/01/Z

Identifier Type: -

Identifier Source: org_study_id