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Completed

NCT Number: NCT00538135

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Psychological Medicine

Glasgow, Strathclyde, G12 0XH, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

Treatment as Usual

Other

Standard National Health Service treatment as usual for borderline personality disorder

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • University of Glasgow
  • University of London
  • University of York
  • Wellcome Trust

Registry information

Official study 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

Acronym: BOSCOT

Important dates

Study start
2002
Study completion
2005
First posted
Oct 2, 2007
Registry last updated
Oct 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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