Bergström G, Lohela-Karlsson M, Kwak L, Bodin L, Jensen I, Torgén M, Nybergh L
Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institutet, SE-171 77, Stockholm, Sweden.
Centre for Occupational and Environmental Medicine, Stockholm County Council, SE-113 65, Stockholm, Sweden.
BMC Public Health. 2017 May 12;17(1):436. doi: 10.1186/s12889-017-4329-1.
Common mental disorders (CMDs) are among the leading causes of sick leave in Sweden and other OECD countries. They result in suffering for the individual and considerable financial costs for the employer and for society at large. The occupational health service (OHS) can offer interventions in which both the individual and the work situation are taken into account. The aim of this paper is to describe the design of a study evaluating the effectiveness of an intervention given at the OHS to employees with CMDs or stress-related symptoms at work. In addition, intervention fidelity and its relation to the outcome will be assessed in a process analysis.
The study is designed as a cluster randomized trial in which the participating OHS consultants are randomized into either delivering the intervention or performing care as usual. Employees with CMDs or stress-related symptoms at work are recruited consecutively by the OHS consultants. The intervention aims to improve the match between the employee and the job situation. Interviews are held individually with the employee and the nearest supervisor, after which a joint meeting with both the employee and the supervisor takes place. A participatory approach is applied by which the supervisor and the employee are guided by the OHS consultant and encouraged to actively take part in problem solving concerning the work situation. Outcomes will be assessed at baseline and at six and 12 months. A long-term follow-up at 3 years will also be performed. The primary outcome is registered sickness absence during a 1-year period after study inclusion. Secondary outcomes are mental health and work ability. The intervention's cost effectiveness, compared to treatment as usual, both for society and for the employer will be evaluated. A process evaluation by both the OHS consultants and the employee will be carried out.
The study includes analyses of the effectiveness of the intervention (clinical and economic) as well as an analysis of its implementation at the participating OHSs. Possible methodological challenges such as selection bias and risk of contamination between OHS consultants delivering the experimental condition and consultants giving usual care are discussed.
ClinicalTrials NCT02563743 Sep 28 2015.
常见精神障碍（CMD）是瑞典和其他经合组织国家病假的主要原因之一。它们给个人带来痛苦，给雇主和整个社会造成相当大的经济成本。职业健康服务（OHS）可以提供同时考虑个人和工作环境的干预措施。本文的目的是描述一项研究的设计，该研究评估OHS针对患有CMD或工作中与压力相关症状的员工所提供干预措施的有效性。此外，将在过程分析中评估干预的保真度及其与结果的关系。
该研究设计为整群随机试验，参与的OHS顾问被随机分为提供干预措施或照常提供护理。OHS顾问连续招募患有CMD或工作中与压力相关症状的员工。干预旨在改善员工与工作环境之间的匹配度。分别与员工和其直属上级进行面谈，之后员工和上级共同参加会议。采用参与式方法，在OHS顾问的指导下，上级和员工被鼓励积极参与解决与工作环境有关的问题。将在基线、6个月和12个月时评估结果。还将进行3年的长期随访。主要结果是纳入研究后1年内登记的病假情况。次要结果是心理健康和工作能力。将评估干预措施与照常治疗相比对社会和雇主的成本效益。OHS顾问和员工都将进行过程评估。
该研究包括对干预措施有效性（临床和经济）的分析以及对其在参与的OHS中的实施情况的分析。讨论了可能的方法学挑战，如选择偏倚以及提供实验条件的OHS顾问与提供常规护理的顾问之间的污染风险。
ClinicalTrials NCT02563743 2015年9月28日。
