Clinical trial NCT00538135: BOSCOT : A Randomised Controlled Trial of Cognitive Behavioural Therapy in Borderline Personality Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Borderline Personality Disorder
Keywords: randomised controlled trial
borderline personality disorder
cognitive behavioural therapy
treatment as usual
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: University of Glasgow
name: University of London
name: University of York
First posted: 2007-10-02
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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:

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).

Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: At both 12 and 24 months post randomisation.
Secondary outcomes:
measure: 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)
timeFrame: 6, 12, 18 and 24 months post randomisation
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Psychological Medicine
state: Strathclyde
Study officials:
affiliation: University of Glasgow
name: Kate Davidson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.