Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vumc.nl/

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

  1. 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.

  2. 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.

  3. 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.

Editorial Notes