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Open Access Study protocol

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]

Nelleke van 't Veer-Tazelaar12*, Harm van Marwijk12, Patricia van Oppen123, Giel Nijpels12, Hein van Hout12, Pim Cuijpers34, Wim Stalman12 and Aartjan Beekman123

Author Affiliations

1 Department of General Practice, VU University Medical Centre, Amsterdam, The Netherlands

2 Institute for Research in Extramural Medicine, VU University Medical Centre, Amsterdam, The Netherlands

3 Department of Psychiatry, VU University Medical Centre, Amsterdam, The Netherlands

4 Department of Clinical Psychology, VU University Medical Centre, Amsterdam, The Netherlands

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BMC Public Health 2006, 6:186  doi:10.1186/1471-2458-6-186

Published: 18 July 2006

Abstract

Background

In frail elderly, the effects of depression and anxiety are deep encroaching. Indicated prevention studies, aimed at subjects with subthreshold disorder, have shown that well designed interventions are capable of reducing the incidence of depression and anxiety. In this randomised prevention trial for elderly, living in the community and suffering from subthreshold depression and anxiety, a stepped care programme was put together to be tested versus usual (GP) care.

Methods/design

Design: randomised controlled trial.

(See figure 1: organisation chart) together with two other projects, this project is part of a national consortium that investigates the prevention of anxiety and depressive disorders in later life using a stepped care programme. The three projects have their own particular focus. This project is aimed at elderly living in the community.

Inclusion: subjects with a high risk for depression and anxiety without clinical evidence of these syndromes. The participants are 75 years of age and over and have subthreshold symptoms of depression and or anxiety: they score above the cut-off point on the self-report Centre for Epidemiologic Studies Depression (CES-D) scale, but the criteria for a major depressive disorder or anxiety disorder (panic disorder, agoraphobia, social phobia, generalized anxiety disorder) according to a validated interview, the Mini International Neuropsychiatric Interview (MINI) are not fulfilled.

Outcomes:

primary outcome: incidence of a depressive or anxiety disorder over a period of two years (MINI);

secondary outcome: a positive influence of the intervention, a stepped care programme, on symptoms of depression and anxiety and on quality of life as assessed with the CES D, the HADS A and the SF36 respectively (i.e. stabilisation or improvement of symptoms) [see table 1].

Measurements:

Take place at baseline and at 3, 6, 9, 12, 18 and 24 months. Trained independent evaluators assess depression and anxiety status, the primary end point (6, 12, 18, 24 months) [see table 2].

Discussion

Late-life depression and anxiety are characterised by high prevalence, unfavourable prognosis, reduced quality of life, excess mortality and substantial societal costs. No health service, however well equipped, will be able to effectively treat all elderly with depression and anxiety. Therefore, development of (cost) effective means to prevent these disorders is very important.