Borderline Personality DisorderPhase 3BOSCOTNCT00538135
BOSCOT : A Randomised Controlled Trial of Cognitive Behavioural Therapy in Borderline Personality Disorder
A Phase 3 study testing Cognitive Behavioural Therapy and Treatment as usual in people with Borderline Personality Disorder, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Cognitive Behavioural Therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2002to Mar 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Psychological Medicine
Glasgow, Strathclyde, G12 0XH
About this 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
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.
Read the 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).
- Conditions
- Borderline Personality Disorder
- Being tested
- Cognitive Behavioural Therapy, Treatment as usual
- Keywords
- randomised controlled trial, borderline personality disorder, cognitive behavioural therapy, treatment as usual
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
Treatment as usualOther
Standard National Health Service treatment as usual for borderline personality disorder
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Cognitive Behavioural Therapy; Other: Treatment as usual |
| 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. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 6, 12, 18 and 24 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startFeb 2002
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, University of Glasgow, University of London, University of York
- Investigators
- Kate Davidson, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538135
- Sponsor's protocol ID
- 064027/Z/01/Z
- Acronym
- BOSCOT
- Status last verified
- Sep 2007
- First submitted
- 29 Sep 2007
- Last updated
- 2 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32368793
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00538135
- Acronym / sponsor ID
- BOSCOT / 064027/Z/01/Z
- Conditions
- Borderline Personality Disorder
- Keywords
- randomised controlled trial, borderline personality disorder, cognitive behavioural therapy, treatment as usual
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Wellcome Trust, University of Glasgow, University of London, University of York
- Study start
- Feb 2002
- Study completion
- Mar 2005 (actual)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive Behavioural Therapy, Other: Treatment as usualCognitive 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 |
| 2 | Active comparator | Other: Treatment as usualTreatment 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy | Behavioural | 1 |
| Treatment as usualStandard National Health Service treatment as usual for borderline personality disorder | Other | 1, 2 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2007.
- Derived from this study: PubMed 32368793Storebo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Davidson, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Behavioural Therapy and Treatment as usual in people with Borderline Personality Disorder, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: At both 12 and 24 months post randomisation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00538135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2007.