Contact information
Type
Scientific
Primary contact
Dr P.J. van 't Veer-Tazelaar
ORCID ID
Contact details
EMGO Institute for Research in Extramural Medicine
Department of General Practice
Vrije University Medical Centre
Van der Boechorststraat 7
Room D556
Amsterdam
1081 HV
Netherlands
+31 (0)20 444 9811
pj.vantveer@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR418
Study information
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
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Anxiety, depression
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Incidence of clinical anxiety and/or major depression in two years (Mini International Neuropsychiatric Interview [MINI])
Secondary outcome measures
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
Overall trial start date
15/09/2004
Overall trial end date
15/09/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
170
Participant 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
Recruitment start date
15/09/2004
Recruitment end date
15/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
EMGO Institute for Research in Extramural Medicine
Amsterdam
1081 HV
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (Netherlands)
Sponsor details
EMGO Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Results
van 't Veer-Tazelaar N, van Marwijk H, van Oppen P, Nijpels G, van Hout H, Cuijpers P, Stalman W, Beekman A, Prevention of anxiety and depression in the age group of 75 years and over: a randomised controlled trial testing the feasibility and effectiveness of a generic stepped care programme among elderly community residents at high risk of developing anxiety and depression versus usual care [ISRCTN26474556]., BMC Public Health, 2006, 6, 186, doi: 10.1186/1471-2458-6-186.
-
Results
van't Veer-Tazelaar PJ, van Marwijk HW, van Oppen P, van Hout HP, van der Horst HE, Cuijpers P, Smit F, Beekman AT, Stepped-care prevention of anxiety and depression in late life: a randomized controlled trial., Arch. Gen. Psychiatry, 2009, 66, 3, 297-304, doi: 10.1001/archgenpsychiatry.2008.555.
-
Results
van't Veer-Tazelaar PJ, van Marwijk HW, van Oppen P, van der Horst HE, Smit F, Cuijpers P, Beekman AT, Prevention of late-life anxiety and depression has sustained effects over 24 months: a pragmatic randomized trial., Am J Geriatr Psychiatry, 2011, 19, 3, 230-239.