Abstract
BackgroundCommon 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.MethodsThe 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.DiscussionThe 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 registrationClinicalTrials.gov Identifier: NCT03346395 Registered January, 12 2018.
Highlights
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
It is estimated that common mental disorders (CMDs), i.e. mild to moderate depression, anxiety, adjustment and stress-related disorders affect about one-third of the European working-age population
In line with previous research, we found that the first concern of primary health care professionals is patients’ psychological and physical well-being; the process of RTW is often of secondary importance [10]
Summary
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. It is estimated that common mental disorders (CMDs), i.e. mild to moderate depression, anxiety, adjustment and stress-related disorders affect about one-third of the European working-age population. With its negative impact on the individual’s well-being, financial circumstances, social network and risk of stigmatization, the cost for society in terms of health care, sick leave and productivity loss for employers is high. In 2013, the total costs for mental health in Sweden, including sick leave, amounted to some SEK 65 billion EUR 6 billion) [2]
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