BOrderline personality disorder Study of COgnitive Therapy trial

ISRCTN	ISRCTN86177428
DOI	https://doi.org/10.1186/ISRCTN86177428
ClinicalTrials.gov (NCT)	NCT00538135
Protocol serial number	064027; 01/27
Sponsor	University of Glasgow (UK)
Funder	The Wellcome Trust (UK) (grant ref: 064027)

Submission date: 22/07/2005
Registration date: 22/07/2005
Last edited: 26/11/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Kate Davidson
Scientific

Glasgow Institute of Psychosocial Interventions
Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Phone	+44 (0)141 211 3900
Email	k.davidson@clinmed.gla.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre, randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial of cognitive therapy plus treatment as usual versus treatment as usual in the treatment of borderline personality disorder
Study acronym	BOSCOT
Study objectives	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(s)	Research Ethics Committee of Greater Glasgow Primary Care NHS Trust gave approval on the 15th August 2001
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/10/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	106
Key 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
Key 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)
Date of first enrolment	01/02/2002
Date of final enrolment	01/10/2004

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Glasgow Institute of Psychosocial Interventions

Glasgow
G12 0XH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	cost-effectiveness results	01/10/2006	Yes	No
Results article	effectiveness results	01/10/2006	Yes	No
Results article	six year follow up results	01/12/2010	Yes	No
Protocol article	Protocol	01/10/2006	Yes	No