|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00538135 |
|
Date of registration:
|
29/09/2007 |
|
Primary sponsor: |
|
|
Public title:
|
BOSCOT : A Randomised Controlled Trial of Cognitive Behavioural Therapy in Borderline Personality Disorder
BOSCOT |
|
Scientific 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 |
|
Date of first enrolment:
|
February 2002 |
|
Target sample size:
|
106 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00538135 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
Kate Davidson, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Glasgow |
| | |
|
Key inclusion & exclusion criteria
|
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).
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Borderline Personality Disorder
|
|
Intervention(s)
|
|
Behavioral: Cognitive Behavioural Therapy
|
|
Other: Treatment as usual
|
|
Primary Outcome(s)
|
|
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(s)
|
|
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]
|
|
Secondary ID(s)
|
|
064027/Z/01/Z
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|