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ISRCTN
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ISRCTN89922377
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ClinicalTrials.gov identifier
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Public title
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Pilot study of Cognitive Behaviour Therapy (CBT) versus usual treatment in those with Antisocial Personality Disorder (ASPD) with aggressive behaviour
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Scientific title
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Acronym
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ASCOT
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Serial number at source
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G0400922 ID: 71697
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Study hypothesis
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This pilot study has four specific and related aims.
1. Development of treatment
2. Chart treatment as usual
3. Test out standardised measures and different modes of delivery if levels of literacy are found to be poor
4. Determine a preliminary efficacy estimate for CBT in this group
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Lay summary
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Ethics approval
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Added as of 13/08/2007:
1. Ethics Board for lead site: NHS Greater Glasgow Primary Care Trust (Community and Mental Health), approved on 16/05/2005 (ref: 05/S0701/46)
Other sites:
2. St Mary's Research Ethics Committee, approved on 10/06/2005
3. Ealing and West London Mental Health Trust (WLMHT) Local Research Ethics Committee, approved on 17/11/2005
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Antisocial Personality Disorder
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Participants - inclusion criteria
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1. A diagnosis of ASPD with aggressive behaviour
2. Aged 18 or above
3. Affirmation of any item on the Amended MacArthur Community Violence Screening Instrument (MCVSI)* interview (*3 months prior to baseline)
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Participants - exclusion criteria
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1. Those who are currently receiving inpatient treatment for a mental state disorder
2. Those currently receiving a systematic psychological therapy
3. Those who have insufficient knowledge of English to enable them to be assessed adequately and to understand the treatment approach
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Anticipated start date
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13/09/2005
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Anticipated end date
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12/09/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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56 - closed to recruitment - in follow-up
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Interventions
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Cognitive behaviour therapy versus usual treatment
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Primary outcome measure(s)
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Aggression & offending behaviour
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Secondary outcome measure(s)
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1. Social functioning
2. Anxiety and depression
3. Anger
4. Cost effectiveness
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Sources of funding
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Medical Research Council (MRC) (UK) (G0400922)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18667099
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Contact name
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Prof
Kate
Davidson
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Address
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Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
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City/town
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Glasgow
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Zip/Postcode
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G12 0XH
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Country
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United Kingdom
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Tel
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+44 (0)141 211 3908/3900
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Fax
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+44 (0)141 357 4899
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Email
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k.davidson@clinmed.gla.ac.uk
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Sponsor
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Greater Glasgow NHS (UK)
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Address
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Research and Development
Gartnavel Royal Hospital
1055 Great Western Road
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City/town
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Glasgow
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Zip/Postcode
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G12 0XH
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Country
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United Kingdom
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Date applied
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16/08/2005
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Last edited
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20/08/2009
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Date ISRCTN assigned
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07/10/2005
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