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11 February 2012
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| [ Print-friendly version ] |
| BOrderline personality disorder Study of COgnitive Therapy trial |
| ISRCTN | ISRCTN86177428 |
| ClinicalTrials.gov identifier | NCT00538135 |
| Public title | BOrderline personality disorder Study of COgnitive Therapy 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 |
| Acronym | BOSCOT |
| Serial number at source | 064027; 01/27 |
| 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. |
| Lay summary | |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Borderline personality disorder |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 01/02/2002 |
| Anticipated end date | 01/10/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 106 |
| Interventions |
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. |
| 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. |
| 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. |
| Sources of funding | The Wellcome Trust (UK) (grant ref: 064027) |
| Trial website | |
| Publications |
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 |
| Contact name | Prof Kate Davidson |
| Address |
Glasgow Institute of Psychosocial Interventions
Psychological Medicine Gartnavel Royal Hospital 1055 Great Western Road |
| City/town | Glasgow |
| Zip/Postcode | G12 0XH |
| Country | United Kingdom |
| Tel | +44 (0)141 211 3900 |
| Fax | +44 (0)141 357 4899 |
| k.davidson@clinmed.gla.ac.uk | |
| Sponsor | University of Glasgow (UK) |
| Address |
Research & Enterprise
10 The Square |
| City/town | Glasgow |
| Zip/Postcode | G12 8QQ |
| Country | United Kingdom |
| Tel | +44 (0)141 330 5005 |
| Fax | +44 (0)141 330 3218 |
| R-E@gla.ac.uk | |
| Sponsor website: | http://www.gla.ac.uk/ |
| Date applied | 22/07/2005 |
| Last edited | 14/04/2011 |
| Date ISRCTN assigned | 22/07/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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