Contact information
Type
Scientific
Primary contact
Prof Kate Davidson
ORCID ID
Contact details
Glasgow Institute of Psychosocial Interventions
Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
+44 (0)141 211 3900
k.davidson@clinmed.gla.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00538135
Protocol/serial number
064027; 01/27
Study information
Scientific title
A randomised controlled trial of cognitive therapy plus treatment as usual versus treatment as usual in the treatment of borderline personality disorder
Acronym
BOSCOT
Study hypothesis
We anticipate that the addition of cognitive behavioural therapy to treatment as usual (CBT plus TAU) in participants with borderline personality disorder will decrease the number of participants with in-patient psychiatric hospitalisations or accident and emergency room contact or suicidal acts over twelve months treatment and twelve months follow-up, compared with treatment as usual (TAU). We also anticipate that CBT plus TAU will lead to superior improvement in quality of life, social, cognitive and mental health functioning compared to TAU alone.
Ethics approval
Research Ethics Committee of Greater Glasgow Primary Care NHS Trust gave approval on the 15th August 2001
Study design
Multicentre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Borderline personality disorder
Intervention
Those participants who met the inclusion criteria and who agreed to give written informed consent to take part in the study then completed baseline assessments and were randomly allocated to either one of two active treatment groups namely, TAU, or CBT plus TAU.
Interventions:
CBT is a structured, time limited, psycho-social intervention which has been developed to treat those with 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. Up to 30 sessions (minimum 15) of treatment, 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. 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
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Acts of deliberate self-harm in the twelve months prior to baseline, and the twelve months following baseline. Trial participants are being assessed on all measures at six monthly intervals.
Secondary outcome measures
1. Brief Symptom Inventory
2. Beck Depression Inventory-II
3. State-Trait Anxiety Inventory
4. Social Functioning Questionnaire
5. Inventory of Interpersonal Problems
6. Schema Questionnaire
7. The Euro-Qol quality of life questionnaire
8. Client Service Receipt Inventory (CSRI)
Trial participants are being assessed on all measures at six monthly intervals, except for the Schema Questionnaire and the Brief Symptom Inventory, where both are assessed at end of treatment and end of follow-up only.
Overall trial start date
01/02/2002
Overall trial end date
01/10/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 18 and 65, either sex
2. Met criteria for at least five items of the borderline personality disorder using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) Axis II Personality Disorders (SCID -II)
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
106
Participant 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 two)
Recruitment start date
01/02/2002
Recruitment end date
01/10/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Glasgow Institute of Psychosocial Interventions
Glasgow
G12 0XH
United Kingdom
Sponsor information
Organisation
University of Glasgow (UK)
Sponsor details
Research & Enterprise
10 The Square
Glasgow
G12 8QQ
United Kingdom
+44 (0)141 330 5005
R-E@gla.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 064027)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. Protocol in http://www.ncbi.nlm.nih.gov/pubmed/17032157
2. 2006 effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/17032158
3. 2006 cost-effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/17032159
4. 2010 six year follow up results in http://www.ncbi.nlm.nih.gov/pubmed/21119151
Publication citations
-
Protocol
Davidson K, Tyrer P, Gumley A, Tata P, Norrie J, Palmer S, Millar H, Drummond L, Seivewright H, Murray H, Macaulay F, A randomized controlled trial of cognitive behavior therapy for borderline personality disorder: rationale for trial, method, and description of sample., J. Pers. Disord., 2006, 20, 5, 431-449, doi: 10.1521/pedi.2006.20.5.431.
-
Effectiveness results
Davidson K, Norrie J, Tyrer P, Gumley A, Tata P, Murray H, Palmer S, The effectiveness of cognitive behavior therapy for borderline personality disorder: results from the borderline personality disorder study of cognitive therapy (BOSCOT) trial., J. Pers. Disord., 2006, 20, 5, 450-465, doi: 10.1521/pedi.2006.20.5.450.
-
Six year follow up results
Davidson KM, Tyrer P, Norrie J, Palmer SJ, Tyrer H, Cognitive therapy v. usual treatment for borderline personality disorder: prospective 6-year follow-up., Br J Psychiatry, 2010, 197, 6, 456-462, doi: 10.1192/bjp.bp.109.074286.
-
Palmer S, Davidson K, Tyrer P, Gumley A, Tata P, Norrie J, Murray H, Seivewright H, The cost-effectiveness of cognitive behavior therapy for borderline personality disorder: results from the BOSCOT trial., J. Pers. Disord., 2006, 20, 5, 466-481, doi: 10.1521/pedi.2006.20.5.466.