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BMC Public Health
Published in: BMC Public Health 1/2007

Open Access 01-12-2007 | Study protocol

Design of a randomized controlled trial on the effects of Counseling of mental health problems by Occupational Physicians on return to work: the CO-OP-study

Authors: David S Rebergen, David J Bruinvels, Allard J van der Beek, Willem van Mechelen

Published in: BMC Public Health | Issue 1/2007

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Abstract

Background

Mental health problems often lead to prolonged sick leave. In primary care, the usual approach towards these patients was the advice to take rest and not return to work before all complaints had disappeared. When complaints persist, these patients are often referred to psychologists from primary and specialized secondary care. As an alternative, ways have been sought to activate the Dutch occupational physician (OP) in primary care. Early 2000, the Dutch Association of Occupational Physicians (NVAB) published a guideline concerning the management by OPs of employees with mental health problems. The guideline received positive reactions from employees, employers and Dutch OPs. This manuscript describes the design of a study, which aims to assess the effects of the guideline, compared with usual care.

Methods/Design

In a randomized controlled trial (RCT), subjects in the intervention group were treated according to the guideline. The control group received usual care, with minimal involvement of the OP and easy access to a psychologist. Subjects were recruited from two Dutch police departments. The primary outcomes of the study are return to work and treatment satisfaction by the employee, employer, and OP. A secondary outcome is cost-effectiveness of the intervention, compared with usual care. Furthermore, prognostic measures are taken into account as potential confounders. A process evaluation will be done by means of performance indicators, based on the guideline.

Discussion

In this pragmatic trial, effectiveness instead of efficacy is studied. We will evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options in occupational health practice for employees on sick leave due to mental health problems. Additionally, they may contribute to new and better-suited guidelines and stepped care. Results will become available during 2007.

Trial registration

Current Controlled Trials ISRCTN34887348
Appendix
Available only for authorised users
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Metadata
Title
Design of a randomized controlled trial on the effects of Counseling of mental health problems by Occupational Physicians on return to work: the CO-OP-study
Authors
David S Rebergen
David J Bruinvels
Allard J van der Beek
Willem van Mechelen
Publication date
01-12-2007
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2007
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/1471-2458-7-183

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