Prevention of anxiety and depression in the elderly

ISRCTN	ISRCTN26474556
DOI	https://doi.org/10.1186/ISRCTN26474556
Secondary identifying numbers	NTR418

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 30/03/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr P.J. van 't Veer-Tazelaar
Scientific

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

Phone	+31 (0)20 444 9811
Email	pj.vantveer@vumc.nl

Study information

Study design	Multicentre, randomised, single blind, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
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
Study acronym	PIKO-D
Study objectives	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(s)	The design and conduct of the study was approved by the Ethics Committee of Vrije University Medical Centre, Amsterdam.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/09/2004
Completion date	15/09/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	170
Key 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
Key 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
Date of first enrolment	15/09/2004
Date of final enrolment	15/09/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

EMGO Institute for Research in Extramural Medicine

Amsterdam
1081 HV
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (Netherlands)
University/education

EMGO Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Website	http://www.vumc.nl/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	18/07/2006	Yes	No
Results article	results	01/03/2009	Yes	No
Results article	results	01/03/2011	Yes	No