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Open Access 01-12-2009 | Study protocol

Effectiveness and cost-effectiveness of an exposure-based return-to-work programme for patients on sick leave due to common mental disorders: design of a cluster-randomized controlled trial

Authors: Erik Noordik, Frank J van Dijk, Karen Nieuwenhuijsen, Jac JL van der Klink

Published in: BMC Public Health | Issue 1/2009

Abstract

Background

To reduce the duration of sick leave and loss of productivity due to common mental disorders (CMDs), we developed a return-to-work programme to be provided by occupational physicians (OPs) based on the principles of exposure in vivo (RTW-E programme). This study evaluates this programme's effectiveness and cost-effectiveness by comparing it with care as usual (CAU). The three research questions we have are: 1) Is an RTW-E programme more effective in reducing the sick leave of employees with common mental disorders, compared with care as usual? 2) Is an RTW-E programme more effective in reducing sick leave for employees with anxiety disorders compared with employees with other common mental disorders? 3) From a societal perspective, is an RTW-E programme cost-effective compared with care as usual?

Methods/design

This study was designed as a pragmatic cluster-randomized controlled trial with a one-year follow-up and randomization on the level of OPs. We aimed for 60 OPs in order to include 200 patients. Patients in the intervention group received the RTW-E programme. Patients in the control group received care as usual. Eligible patients had been on sick leave due to common mental disorders for at least two weeks and no longer than eight weeks. As primary outcome measures, we calculated the time until full return to work and the duration of sick leave. Secondary outcome measures were time until partial return to work, prevalence rate of sick leave at 3, 6, 9, and 12 months' follow-up, and scores of symptoms of distress, anxiety, depression, somatization, and fatigue; work capacity; perceived working conditions; self-efficacy for return to work; coping behaviour; avoidance behaviour; patient satisfaction; and work adaptations. As process measures, we used indices of compliance with the intervention in the intervention group and employee-supervisor communication in both groups. Economic costs were calculated from a societal perspective. The total costs consisted of the costs of consuming health care, costs of production loss due to sick leave and reduced productivity, and out-of-pocket costs of patients for travelling to their OP.

Discussion

The results will be published in 2009. The strengths and weaknesses of the study protocol are discussed.

Trial registration

ISRCTN72643128

Available only for authorised users

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/9/140/prepub

Title: Effectiveness and cost-effectiveness of an exposure-based return-to-work programme for patients on sick leave due to common mental disorders: design of a cluster-randomized controlled trial
Authors: Erik Noordik
Frank J van Dijk
Karen Nieuwenhuijsen
Jac JL van der Klink
Publication date: 01-12-2009
Publisher: BioMed Central
Published in: BMC Public Health / Issue 1/2009
Electronic ISSN: 1471-2458
DOI: https://doi.org/10.1186/1471-2458-9-140

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Effectiveness and cost-effectiveness of an exposure-based return-to-work programme for patients on sick leave due to common mental disorders: design of a cluster-randomized controlled trial

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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