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

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Treatment as usual
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring randomised controlled trial, borderline personality disorder, cognitive behavioural therapy, treatment as usual

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Psychological Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

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.

Outcomes

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.

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)

Full Information

First Posted
September 29, 2007
Last Updated
September 29, 2007
Sponsor
University of Aberdeen
Collaborators
Wellcome Trust, University of Glasgow, University of London, University of York
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1. Study Identification

Unique Protocol Identification Number
NCT00538135
Brief Title
BOSCOT : A Randomised Controlled Trial of Cognitive Behavioural Therapy in Borderline Personality Disorder
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aberdeen
Collaborators
Wellcome Trust, University of Glasgow, University of London, University of York

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
randomised controlled trial, borderline personality disorder, cognitive behavioural therapy, treatment as usual

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Standard National Health Service treatment as usual for borderline personality disorder
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Davidson, PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychological Medicine
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G12 0XH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32368793
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.
Results Reference
derived

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

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