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Main
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Note: This record shows only 22 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. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN89423966 |
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Date of registration:
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13/02/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of a cognitive-behavioural (schema-focused) therapy in the personality disorder service at Ashworth Hospital
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Scientific title:
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Date of first enrolment:
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01/11/2004 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN89423966 |
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Study type:
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Interventional |
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Study design:
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Independent phase II Medical Research Council (MRC) framework exploratory trial using a randomised controlled trial methodology (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Mairead
Dolan |
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Address:
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Edenfield Centre
Bolton Salford & Trafford Mental Health NHS Trust
Prestwich
M25 3BL
Manchester
United Kingdom |
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Telephone:
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+44 (0)161 772 3855 |
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Email:
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Affiliation:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male personality disorder patients
2. Aged between 18 and 70 years
3. Currently a resident at Ashworth Hospital; new admissions will also be included in the study if they are allocated to stay for the duration of the treatment intervention
Exclusion criteria: 1. Current psychotic symptoms
2. Organic brain syndromes
3. Intelligence Quotient (IQ) less than 70
Age minimum:
Age maximum:
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Personality Disorder
Mental and Behavioural Disorders
Disorders of adult personality and behaviour
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Intervention(s)
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Subjects will be randomly assigned to the 'Treatment As Usual' (TAU) group versus the enhanced CBT group (TAU or SF-CBT). Randomisation will take place in such a way that each of the clinical teams managing cases will have an equal number of cases in the TAU and SF-CBT groups. Randomisation will be conducted, independently, by a remote telephone randomisation service.
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Primary Outcome(s)
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Personal schemata
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Secondary Outcome(s)
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1. Personality traits
2. Risk to others
3. Interpersonal style
4. Emotional regulation
5. Impulsiveness
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Secondary ID(s)
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RDS/03/152
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Source(s) of Monetary Support
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Dangerous & Severe Personality Disorder (DSPD) Programme, Home Office (UK) (ref: RDS/03/152)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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