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ISRCTN
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ISRCTN49123202
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ClinicalTrials.gov identifier
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Public title
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A before and after study to investigate the effectiveness of an individual psychological intervention in reducing anxiety and depression for heart failure patients
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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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N0124183305
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Study hypothesis
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Is psychological therapy for heart failure combined with normal care better than normal care by itself at reducing depression and anxiety, improving coping and helping patients to address a self-identified heart failure related issue and/or a nurse consultant identified heart failure related issue?
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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: Anxiety disorders
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Participants - inclusion criteria
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Heart failure patients scoring 8 or higher on the Hospital and Anxiety Scale, with an issue identified by the nurse consultant that could benefit from psychological input or identified by heart failure patients and discussed with the nurse consultant.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/07/2006
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Anticipated end date
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01/07/2009
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Patients will be randomised into either an immediate treatment or a waiting treatment group.
Patients in both groups will be asked to complete questionnaires at beginning of treatment, end of treatment and at 3 months follow-up.
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Primary outcome measure(s)
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Significant difference between groups in depression, anxiety, coping style, self-identified problem rating, nurse identified problem rating.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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University Hospital Lewisham NHS Trust (UK)
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mrs
Annie
O'Donoghue
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Address
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Heart Failure Service
University Hospital Lewisham
Lewisham High Street
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City/town
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London
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Zip/Postcode
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SE13 6LH
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Country
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United Kingdom
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Tel
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+44 020 8333 3030 x6701
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Fax
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+44
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Email
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annie.odonoghue@uhl.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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21/05/2008
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Date ISRCTN assigned
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28/09/2007
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