Institute of Environmental Medicine, Unit of Intervention and Implementation Research for Worker Health, Karolinska Institutet, Stockholm, Sweden.
University of Groningen, University Medical Center Groningen, Department of Health Sciences, Community & Occupational Medicine, Groningen, The Netherlands.
BMC Public Health. 2021 Sep 26;21(1):1756. doi: 10.1186/s12889-021-11786-6.
Common mental disorders are highly prevalent in the working population, affecting about 1 in 5 persons in the Organisation for Economic Co-operation and Development countries. About 30% of those affected have a first period of sick leave. Despite several attempts to reduce the risk of sick leave among employees with common mental disorders, there is a lack of knowledge about effective, preventive interventions which aim to reduce such risks. This protocol describes the design of a study to evaluate the effectiveness of a problem-solving intervention delivered by first-line managers to employees with common mental disorders on the prevention of sick leave during the 12-month follow-up.
METHODS/DESIGN: The study applies a two-armed cluster-randomized trial design of a problem-solving intervention conducted in private-sector companies. First-line managers are randomized into intervention- or control groups by computer-generated random numbers, allocation ratio 1:1. Employees are eligible if at risk for future sick leave due to common mental disorders. These are identified by self-reported psychological health measured by the General Health Questionnaire 12-item, cut-off ≥3, or a positive answer to risk of sick leave. The intervention is based on problem-solving principles. It involves the training of the first-line managers who then deliver the intervention to employees identified at risk of sick leave. First-line managers in the control group receives a lecture. Primary outcome is number of registered days of sick leave due to common mental disorders during the 12-month follow-up. Secondary outcomes are general health, psychological symptoms, work performance, work ability and psychosocial work environment. A process evaluation will examine the intervention's reach, fidelity, dose delivered, dose received, satisfaction and context. Research assistants managing the screening procedure, outcome assessors and employees are blinded to randomization and allocation.
The study includes analyses of the intervention's effectiveness and an alongside process evaluation. Methodological strengths and limitations, for example the risk of selection bias, attrition and risk of contamination are discussed.
Clinicaltrials.gov NCT04975750 Date of registration: 08/16/2021.
常见精神障碍在工作人群中高度流行，在经济合作与发展组织国家中，约有五分之一的人受到影响。其中约有 30%的人首次请病假。尽管为降低患有常见精神障碍的员工请病假的风险已进行了多次尝试，但对于旨在降低此类风险的有效预防干预措施，我们知之甚少。本方案描述了一项研究的设计，该研究评估了一线经理对患有常见精神障碍的员工实施的问题解决干预措施对预防 12 个月随访期间病假的有效性。
方法/设计：该研究采用了一项两臂群组随机试验设计，对私营部门公司中实施的问题解决干预措施进行了评估。一线经理通过计算机生成的随机数随机分配到干预组或对照组，分配比例为 1:1。如果员工因常见精神障碍而有未来请病假的风险，则符合条件。这些员工通过自我报告的心理健康状况来确定，使用 12 项一般健康问卷进行测量，得分≥3 或对病假风险的回答为肯定。干预措施基于问题解决原则。它包括对一线经理进行培训，然后由一线经理向有请假风险的员工提供干预措施。对照组中的一线经理将接受讲座。主要结局是 12 个月随访期间因常见精神障碍而请病假的注册天数。次要结局是一般健康状况、心理症状、工作表现、工作能力和心理社会工作环境。过程评估将检查干预措施的覆盖范围、保真度、提供的剂量、接受的剂量、满意度和背景。管理筛选程序的研究助理、结局评估者和员工对随机分组和分组均不知情。
该研究包括对干预措施的有效性以及并行过程评估的分析。讨论了方法学上的优势和局限性，例如选择偏倚、失访和污染风险的风险。
Clinicaltrials.gov NCT04975750 注册日期：2021 年 8 月 16 日。
