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ISRCTN
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ISRCTN26474556
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ClinicalTrials.gov identifier
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Public title
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Prevention of anxiety and depression in the elderly
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Scientific title
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A study to test the feasibility and effects of a generic stepped care approach for community elderly with symptoms of subtreshold anxiety and/or depression
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Acronym
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PIKO-D
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Serial number at source
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NTR418
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Study hypothesis
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The stepped care approach will lead to a significantly reduced incidence of clinical anxiety and depression in two years and will reduce symptoms level compared to usual care.
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Ethics approval
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The design and conduct of the study was approved by the Ethics Committee of Vrije University Medical Centre, Amsterdam.
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Study design
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Multicentre, randomised, single blind, active controlled, parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Anxiety, depression
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Participants - inclusion criteria
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1. Persons 75 years of age and over living in the community
2. Centre for Epidemiological Studies Depression (CES-D) score of 16 or higher
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Participants - exclusion criteria
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1. Meeting criteria for major depression and/or clinical anxiety
2. Insufficient mastery of the Dutch language
3. Unwilling or unable to give informed consent
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Anticipated start date
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15/09/2004
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Anticipated end date
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15/09/2007
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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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170
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Interventions
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Stepped care programme:
1. Symptom monitoring every three months (CES-D)
2. Leaflet and selfhelp book coached by homecare nurse
3. Problem solving treatment by community psychiatric nurses (CPN)
4. Suggestion to discuss medication with general practitioner (GP)
Control: usual care
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Primary outcome measure(s)
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Incidence of clinical anxiety and/or major depression in two years (Mini International Neuropsychiatric Interview [MINI])
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Secondary outcome measure(s)
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1. Reduction of self-reported anxiety and/or depressive symptoms as measured with the Center for Epidemiologic Studies Depression Scale (CES-D), the Hospital Anxiety Depression Scale (HADS-A)
2. Improvement of quality of life (36-item short form health survey [SF-36])
3. Mortality
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
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Trial website
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Publications
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Results in:
1. 2006: http://www.ncbi.nlm.nih.gov/pubmed/16848888
2. 2009: http://www.ncbi.nlm.nih.gov/pubmed/19255379
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Contact name
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Dr
P.J.
van 't Veer-Tazelaar
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Address
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EMGO Institute for Research in Extramural Medicine
Department of General Practice
Vrije University Medical Centre
Van der Boechorststraat 7, Room D556
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City/town
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Amsterdam
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Zip/Postcode
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1081 HV
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Country
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Netherlands
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Tel
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+31 (0)20 444 9811
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Fax
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+31 (0)20 444 8361
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Email
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pj.vantveer@vumc.nl
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Sponsor
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Vrije University Medical Centre (VUMC) (Netherlands)
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Address
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EMGO Institute
Van der Boechorststraat 7
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City/town
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Amsterdam
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Zip/Postcode
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1081 BT
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Country
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Netherlands
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Sponsor website:
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http://www.vumc.nl/
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Date applied
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20/12/2005
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Last edited
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10/03/2009
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Date ISRCTN assigned
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20/12/2005
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