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ISRCTN
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ISRCTN66542253
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ClinicalTrials.gov identifier
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Public title
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Comparison of three forms of self help cognitive behavioural therapy
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0560180008
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Study hypothesis
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To implement and compare the impact of three cognitive behavioural therapies: Beating the Blues, workbook and internet based.
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Ethics approval
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Not provided at time of registration
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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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Mental and Behavioural Disorders: Depression
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Participants - inclusion criteria
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1. Patients aged 18+ years old
2. Suffering from depression, mixed anxiety and depression or anxiety disorder
3. Not receiving any form of psychological treatment or counselling
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Participants - exclusion criteria
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1. Active suicidal ideas
2. A current or lifetime diagnosis of psychosis, personality disorder or organic mental disorder
3. Alcohol and/or drug dependence
4. Have taken medication for anxiety and /or depression continuously for 6 months or more immediately prior to entry
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Anticipated start date
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01/06/2006
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Anticipated end date
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01/12/2007
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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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180 referrals to the research although not all have completed the treatment and followup protocol.
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Interventions
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A co-ordinator will establish proactive links with GPs in the area, organize data collection for the research, assess the need for an interpreter to facilitate sessions, and oversee the use of computers by clients GPs will refer patients if they meet certain criteria. Interested individuals will be asked to give signed consent and then complete a baseline CORE assessment before being randomly allocated to one of the three self-help tools.
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Primary outcome measure(s)
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1. Differences in the following indicators of mental health and use of services: total antidepressants dispensed during the 6 months following the diagnosis
2. Use of counselling or other secondary mental health services in the 6 months following the diagnosis
3. Programme completed or interrupted
4. Consultations with primary care staff over the 6 months follow up period
5. Consultations with secondary care over the 6 months follow up period
5. CORE assessment scores at 6 weeks.
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Secondary outcome measure(s)
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At six months the following data items will be recorded for all patients:
1. Consultations with primary care staff over the 6 months follow up period
2. Total antidepressants dispensed during the 6 months following the diagnosis (information gathered from the GP's computer)
3. Use of counselling or other secondary mental health services in the 6 months following the diagnosis and referral to the service (information gathered from the local counseling service and Oxleas mental health Trust)
4. Programme completed or interrupted
CORE assessment scores at 8 weeks
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Sources of funding
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Bexley Care Trust
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Trial website
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Publications
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Contact name
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Dr
Hannah
Patrick
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Address
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Bexley Care Trust
221 Erith Road
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City/town
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Bexleyheath
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Zip/Postcode
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DA7 6HZ
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Country
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United Kingdom
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Tel
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+44 020 8298 6210
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Fax
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+44 020 8298 6049
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Email
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Hannah.patrick@bexley.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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05/11/2007
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Date ISRCTN assigned
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28/09/2007
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