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ISRCTN
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ISRCTN76240576
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ClinicalTrials.gov identifier
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Public title
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Effects of a psychotherapy intervention in depressed patients with coronary artery disease
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Scientific title
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A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a randomised controlled trial (SPIRR-CAD)
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Acronym
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SPIRR-CAD
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Serial number at source
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ZKSK-371
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Study hypothesis
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To determine the effects of a psychotherapy intervention on symptoms of depression in depressed patients with coronary artery disease
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Ethics approval
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Ethics Committee, University of Göttingen. Date of approval: 25 October 2007 (ref: 5/10/07)
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Study design
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Randomised, controlled, multi-centre clinical trial with masked evaluation (observer)
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Depressive symptoms in patients with coronary artery disease
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Participants - inclusion criteria
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1. Gender: both
2. Minimum age: 18, maximum age: 75
3. Patients hospitalised for any manifestation of coronary heart disease with recent (<3 months old) coronary angiograms and elevated questionnaire scores for depression (Hospital Anxiety and Depression Scale [HADS] depression subscale >=8)
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Participants - exclusion criteria
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1. Severe heart failure or other acutely life-threatening conditions
2. Severe chronic inflammatory disease
3. Current suicidal tendency
4. Severe depressive episode or other severe mental illness
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Anticipated start date
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01/10/2008
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Anticipated end date
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30/09/2013
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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569
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Interventions
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Experimental intervention: Stepwise, manualised individual and group psychotherapy in addition to usual cardiological care. Patients randomised in the intervention group receive 3 sessions of individual psychotherapy (50 minutes per session, 1 session per week). Only those patients with persisting symptoms of depression receive additional 25 sessions of group psychotherapy (90 minutes per session) over 10 months (first 20 sessions on a weekly basis, then 5 sessions once a month).
Control intervention: Usual cardiological care including one psychosocial information session
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Primary outcome measure(s)
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Changes from baseline to year 1 in depressive symptoms (HADS-D)
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Secondary outcome measure(s)
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The following will be monitored up to 24 months:
1. Remission of depressive disorder (Structured Clinical Interview [SCID]) at baseline and 12 months
2. Type D pattern, assessed by a self rating questionnaire (DS-14) at baseline, 1, 6, 12, and 24 months
3. Health-related quality of life, evaluated by the self rating questionnaires the 36-item Short Form health survey (SF-36) and EuroQuol-5D at baseline, 6, 12, and 24 months
4. Cardiovascular risk profile
5. Neuroendocrine and immunological activation
6. Coagulation
7. Heart rate variability
8. Cardiac events
9. Health care utilisation and costs
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Sources of funding
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German Research Foundation (Deutsche Forschungsgemeinschaft; DFG) (Germany)
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Trial website
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Publications
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Contact name
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Prof
Christoph
Herrmann-Lingen
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Address
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University of Göttingen
Department of Psychosomatic Medicine and Psychotherapy
von-Siebold-Str. 5
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City/town
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Göttingen
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Zip/Postcode
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D-37075
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Country
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Germany
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Tel
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+49 551 39 67 07
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Fax
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+49 551 39 19150
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Email
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cherrma@gwdg.de
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Sponsor
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University of Göttingen (Germany)
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Address
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c/o Prof. Dr. Christoph Herrmann-Lingen
Department of Psychosomatic Medicine and Psychotherapy
von-Siebold-Str. 5
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City/town
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Göttingen
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Zip/Postcode
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D-37075
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Country
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Germany
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Tel
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+49 551 39 67 07
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Fax
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+49 551 39 19150
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Email
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cherrma@gwdg.de
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Sponsor website:
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http://www.med.uni-goettingen.de
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Date applied
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26/02/2008
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Last edited
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01/04/2008
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Date ISRCTN assigned
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27/03/2008
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