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Prevention of anxiety and depression in the elderly
DOI 10.1186/ISRCTN26474556
ClinicalTrials.gov identifier
EudraCT number
Public title Prevention of anxiety and depression in the elderly
Scientific title 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
Acronym PIKO-D
Serial number at source NTR418
Study hypothesis 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.
Lay summary
Ethics approval The design and conduct of the study was approved by the Ethics Committee of Vrije University Medical Centre, Amsterdam.
Study design Multicentre, randomised, single blind, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Anxiety, depression
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 15/09/2004
Anticipated end date 15/09/2007
Status of trial Completed
Patient information material
Target number of participants 170
Interventions 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
Primary outcome measure(s) Incidence of clinical anxiety and/or major depression in two years (Mini International Neuropsychiatric Interview [MINI])
Secondary outcome measure(s) 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
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Trial website
Publications 1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16848888
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19255379
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21425519
Contact name Dr  P.J.  van 't Veer-Tazelaar
  Address EMGO Institute for Research in Extramural Medicine
Department of General Practice
Vrije University Medical Centre
Van der Boechorststraat 7, Room D556
  City/town Amsterdam
  Zip/Postcode 1081 HV
  Country Netherlands
  Tel +31 (0)20 444 9811
  Fax +31 (0)20 444 8361
  Email pj.vantveer@vumc.nl
Sponsor Vrije University Medical Centre (VUMC) (Netherlands)
  Address EMGO Institute
Van der Boechorststraat 7
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Sponsor website: http://www.vumc.nl/
Date applied 20/12/2005
Last edited 30/03/2011
Date ISRCTN assigned 20/12/2005
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