Preventing Sickness Absenteeism Among Employees With Common Mental Disorders and Stress-related Symptoms: a Cluster Randomized Trial of a Problem-solving Based Intervention Versus Care-as-usual Conducted at the Occupational Health Services
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from Baseline in total registered sickness absenteeism during the 12 month follow-up period.
研究概览
简要总结
Purpose
Common mental disorders (CMD:s) are the leading cause of sick-leave spells in Sweden, resulting in suffering for the individual and financial costs for the employer as well as for society at large. Studies on interventions that address stress and mental ill-health and that focus on sick leave and return to work (RTW) show little or no effect of commonly used methods such as medication or psychological approaches. Furthermore, these interventions often focus on the individual's symptoms without considering their work situation. The occupational health services (OHS) has knowledge of the employee's work environment and can offer treatment facilitating the employee's RTW and improving the employee's work ability while taking into account both the individual and the work situation. The intervention in the current study will be performed at the OHS.
The study aim is two-fold: first, an intervention that addresses both individual and workplace related aspects among employees with work-related CMD:s and/or stress related symptoms will be evaluated. In particular, the treatment's cost-effectiveness and impact on sick leave and mental health will be studied. Secondly, the concerned OHS staff's adherence to the intended treatment and associations with the outcome of the intervention will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The employee suffers from stress related symptoms or work-related common mental disorders.
- •The employee is either not on sick leave or is on sick leave for a maximum of 3 consecutive months (full or part time).
- •The employee understands both written and spoken Swedish.
- •The employees nearest supervisor should be aware of the employees visit(s) at the OHS (to avoid differential selection into the experimental and the control condition)
排除标准
- •Pregnancy
- •Post traumatic stress-disorder
- •Severe mental disorders (e.g. psychosis)
- •Any co-morbidity that may substantially affect the employee's ability to work and/or quality of life.
结局指标
主要结局
Change from Baseline in total registered sickness absenteeism during the 12 month follow-up period.
时间窗: At baseline and 12 months after baseline.
(1) Total sick leave in days, register data (sickness benefit and disability pension). Sickness benefit and disability pension will also be analyzed separately. The analyses will be repeated for outcomes on registered sick leave at a three-years follow-up
次要结局
- Maslach Burnout Inventory - General Survey, Exhaustion-scale(Will be assessed at baseline and after 6 and 12-months of study inclusion.)
- The prevalence of no sick leave, part-time sick leave and full-time sick leave during the 12 months follow-up period following baseline(Twelve months after baseline)
- Demand-control-support model. Prognostic variable.(Baseline and at 6 and 12 months of study inclusion)
- Change from baseline in self-reported sickness absenteeism during the 12 months follow-up period(At baseline and during monthly follow-ups for a period of 12 months)
- Sickness presenteeism(Will be assessed at baseline and after 6 and 12-months of study inclusion.)
- The Institute of Stress Medicine's instrument for self-rating of stress-related Exhaustion Disorder (s-ED)(Will be assessed at baseline and after 6 and 12-months of study inclusion.)
- European Quality of Life - 5 Dimensions questionnaire (EQ-5D)(Will be measured at baseline and after 6 and 12-months of study inclusion.)
- Change in work conditions. Prognostic variable.(At 6 and 12 months after intervention)
- Work performance impairment due to health problems(Will be assessed at baseline and once a month during a 12-month follow-up period)
- Work satisfaction(Will be assessed at baseline and after 6 and 12 months.)
- Self-perceived health(Will be assessed at baseline and after 6 and 12-months of study inclusion.)
- Karolinska Sleep Questionnaire, Insomnia sub-scale(Will be measured at baseline and after 6 and 12-months of study inclusion.)
- Other work related variables such as ongoing conflicts with the superior, perceived loss of control over work tasks and conflicts between the employee´s values and how the work actually is done. Prognostic variables.(Baseline and at 6 months after study inclusion)
- Change in the organization. Prognostic variable.(At 6 and 12 months after intervention)
- Among those sick listed at baseline: Time to full Return to Work (RTW) during a follow-up period of 12 months(At baseline and during monthly follow-ups for a period of 12 months)
- Work performance impairment due to problems in working environment(Will be assessed at baseline and every other month (eighth weeks intervals) during a 12-month follow-up period)
- Self-reported stress(At baseline and every other month (eighth weeks intervals) during a follow-up period of 12 months)
- Participants' satisfaction and experiences with the intervention or treatment as usual will be assessed at 6 months after completed intervention by eleven items (response format from 0-10 or yes/no/do not know). Process evaluation data.(Will be assessed 6 months after intervention.)
- Among those sick listed at baseline: Time to Return to Work (RTW) during a follow-up period of 12 months(At baseline and during monthly follow-ups for a period of 12 months)
- Cost-effectiveness of the intervention compared to treatment as usual.(At 12 months after baseline)
- Work ability index (WAI)(Will be assessed at baseline and after 6 and 12-months of study inclusion.)
- Hospital Anxiety and Depression Scale(Will be assessed at baseline and after 6 and 12-months of study inclusion.)
- Three years follow-up: Change from Baseline in registered sickness absenteeism during a 3-year follow-up period(At baseline and 3 years after baseline.)
- Physical activity. Prognostic variable.(At 6 and 12 months after intervention)
- OHS staff's adherence to the intervention (process evaluation data)(Assessed at the end of the 12-18 months long recruitment period)
- Implementation of the intervention and entire research project at the OHS units (process evaluation data)(Assessed at the end of the 12-18 months long recruitment period)
研究者
Gunnar Bergström
Associate professor
Karolinska Institutet