NDLI: Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA)

Content Provider	Springer Nature : BioMed Central
Author	Björk Brämberg, Elisabeth Holmgren, Kristina Bültmann, Ute Gyllensten, Hanna Hagberg, Jan Sandman, Lars Bergström, Gunnar
Abstract	Background Common mental disorders affect about one-third of the European working-age population and are one of the leading causes of sick leave in Sweden and other OECD countries. Besides the individual suffering, the costs for society are high. This paper describes the design of a study to evaluate a work-related, problem-solving intervention provided at primary health care centers for employees on sick leave due to common mental disorders. Methods The study has a two-armed cluster randomized design in which the participating rehabilitation coordinators are randomized into delivering the intervention or providing care-as-usual. Employees on sick leave due to common mental disorders will be recruited by an independent research assistant. The intervention aims to improve the employee’s return-to-work process by identifying problems perceived as hindering return-to-work and finding solutions. The rehabilitation coordinator facilitates a participatory approach, in which the employee and the employer together identify obstacles and solutions in relation to the work situation. The primary outcome is total number of sick leave days during the 18-month follow-up after inclusion. A long-term follow-up at 36 months is planned. Secondary outcomes are short-term sick leave (min. 2 weeks and max. 12 weeks), psychological symptoms, work ability, presenteeism and health related quality of life assessed at baseline, 6 and 12-month follow-up. Intervention fidelity, reach, dose delivered and dose received will be examined in a process evaluation. An economic evaluation will put health-related quality of life and sick leave in relation to costs from the perspectives of society and health care services. A parallel ethical evaluation will focus on the interventions consequences for patient autonomy, privacy, equality, fairness and professional ethos and integrity. Discussion The study is a pragmatic trial which will include analyses of the intervention’s effectiveness, and a process evaluation in primary health care settings. Methodological strengths and challenges are discussed, such as the risk of selection bias, contamination and detection bias. If the intervention shows promising results for return-to-work, the prospects are good for implementing the intervention in routine primary health care. Trial registration ClinicalTrials.gov Identifier: NCT03346395 Registered January, 12 2018.
Related Links	https://bmcpublichealth.biomedcentral.com/counter/pdf/10.1186/s12889-018-5816-8.pdf
Ending Page	11
Page Count	11
Starting Page	1
File Format	HTM / HTML
ISSN	14712458
DOI	10.1186/s12889-018-5816-8
Journal	BMC Public Health
Issue Number	1
Volume Number	18
Language	English
Publisher	BioMed Central
Publisher Date	2018-07-18
Access Restriction	Open
Subject Keyword	Public Health Medicine Epidemiology Biostatistics Vaccine Environmental Health Common mental disorders Adjustment disorders Anxiety disorders Depression Cluster-randomized trial Problem solving skills Return to work Sick leave Economic evaluation Ethical evaluation Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Public Health, Environmental and Occupational Health
Journal Impact Factor	3.5/2023
5-Year Journal Impact Factor	3.9/2023

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