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ISRCTN
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ISRCTN72677277
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ClinicalTrials.gov identifier
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Public title
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Psychological treatments for severe and complex mental health problems/personality disorder. A phase II randomised controlled trial
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Scientific title
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Acronym
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SPeDi (Sheffield Personality Disorders)
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Serial number at source
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ZC56
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Study hypothesis
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For patients with Cluster B personality disorders (as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV], Axis II), enhanced community mental health team (CMHT) management plus a cognitively-based psychotherapy is a more effective treatment than routine CMHT management alone. (The psychotherapies being used are Cognitive Analytic Therapy [CAT] and Cognitive Behavioural Therapy [CBT].)
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Lay summary
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Not provided at time of registration
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Ethics approval
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North Sheffield Ethics Office on 17/01/05 (ref: 04/Q2308/80)
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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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Personality disorders
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Participants - inclusion criteria
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1. Adult out-patients (18-65) of community mental health teams (CMHTs).
2. Minimum one year history of severe, complex mental health problems, diagnosis of at least one Cluster B personality disorder.
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Participants - exclusion criteria
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Current in-patient, actively psychotic, primary drug/alcohol abuse.
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Anticipated start date
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01/05/2005
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Anticipated end date
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31/10/2007
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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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220
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Interventions
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CMHT management alone versus CMHT management plus cognitively-based psychotherapy.
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Primary outcome measure(s)
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The Risk subscale of the CORE tool (Clinical Outcomes in Routine Evaluation)
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Secondary outcome measure(s)
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Health Status Questionnaire (SF36), Borderline Personality Disorder Checklist (BPD-CL), incidents of self-harm (Acts of Deliberate Self-Harm Inventory, ADSHI), economic cost of service use.
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Sources of funding
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University of Sheffield, Sheffield Health and Social Research Consortium (ref ZC56) (UK)
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Trial website
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Publications
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Contact name
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Prof
Glenys
Parry
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Address
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Mental Health Section
The School of Health and Related Research (ScHARR)
University of Sheffield
Regent Court
30 Regent Street
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City/town
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Sheffield
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Zip/Postcode
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S1 4DA
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Country
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United Kingdom
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Tel
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+44 (0)114 2220817
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Fax
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+44 (0)114 2224095
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Email
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G.D.Parry@sheffield.ac.uk
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Sponsor
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Sheffield Health and Social Research Consortium (UK)
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Address
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Fulwood House
Old Fulwood Road
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City/town
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Sheffield
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Zip/Postcode
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S10 3TH
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Country
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United Kingdom
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Date applied
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26/05/2005
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Last edited
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07/07/2011
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Date ISRCTN assigned
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29/07/2005
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