Common Mental Disorders and/or Stress Related Symptoms Clinical Trial
Official title:
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
| Verified date | September 2021 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | May 30, 2020 |
| Est. primary completion date | May 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 63 Years |
| Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - Bullying - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Karolinska Institutet | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet |
Sweden,
Bergström G, Lohela-Karlsson M, Kwak L, Bodin L, Jensen I, Torgén M, Nybergh L. Preventing sickness absenteeism among employees with common mental disorders or stress-related symptoms at work: Design of a cluster randomized controlled trial of a problem-solving based intervention versus care-as-usual conducted at the Occupational Health Services. BMC Public Health. 2017 May 12;17(1):436. doi: 10.1186/s12889-017-4329-1. — View Citation
Keus Van De Poll M, Bergström G, Jensen I, Nybergh L, Kwak L, Lornudd C, Lohela-Karlsson M. Cost-Effectiveness of a Problem-Solving Intervention Aimed to Prevent Sickness Absence among Employees with Common Mental Disorders or Occupational Stress. Int J Environ Res Public Health. 2020 Jul 20;17(14). pii: E5234. doi: 10.3390/ijerph17145234. — View Citation
Keus van de Poll M, Nybergh L, Lornudd C, Hagberg J, Bodin L, Kwak L, Jensen I, Lohela-Karlsson M, Torgén M, Bergstrom G. Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services. Occup Environ Med. 2020 Jul;77(7):454-461. doi: 10.1136/oemed-2019-106353. Epub 2020 Apr 14. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in total registered sickness absenteeism during the 12 month follow-up period. | (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 |
At baseline and 12 months after baseline. | |
| Secondary | Change from baseline in self-reported sickness absenteeism during the 12 months follow-up period | Self-report data obtained every four weeks during the 12-months follow-up period. These data also include short spells of sick leave.
Possible interaction effects on the primary and secondary outcomes for (1) gender x treatment (intervention) and (2) sick leave status (sick leave/no sick leave) x treatment will be checked for and if statistically significant subgroup analyses will be considered. |
At baseline and during monthly follow-ups for a period of 12 months | |
| Secondary | The prevalence of no sick leave, part-time sick leave and full-time sick leave during the 12 months follow-up period following baseline | Change from baseline in self-reported data (no sick leave, 25%, 50%, 75% or 100% sick leave) obtained every fourth week during a follow-up period of 12 months | Twelve months after baseline | |
| Secondary | Among those sick listed at baseline: Time to full Return to Work (RTW) during a follow-up period of 12 months | RTW will be calculated from the study inclusion date until the individual returns in ordinary hours of work during an uninterrupted period of at least four weeks. Self-reported data obtained every fourth week during a follow-up period of 12 months. | At baseline and during monthly follow-ups for a period of 12 months | |
| Secondary | Among those sick listed at baseline: Time to Return to Work (RTW) during a follow-up period of 12 months | RTW will be calculated from the study inclusion date until the individual returns to work in any increased level (25%, 50%, 75% or 100%). Self-reported data obtained every fourth week during a follow-up period of 12 months. | At baseline and during monthly follow-ups for a period of 12 months | |
| Secondary | Work performance impairment due to health problems | Change from baseline in work performance as assessed by a question based on one item from the Work Productivity Activity Impairment - General Health Questionnaire (response format from 0-10). | Will be assessed at baseline and once a month during a 12-month follow-up period | |
| Secondary | Work performance impairment due to problems in working environment | Change from baseline in work performance as assessed by a question based on one item from the Work Productivity Activity Impairment - General Health Questionnaire (response format from 0-10). | Will be assessed at baseline and every other month (eighth weeks intervals) during a 12-month follow-up period | |
| Secondary | Cost-effectiveness of the intervention compared to treatment as usual. | The cost-effectiveness of the intervention will be calculated with regard to production loss (sick leave and performance while at work). | At 12 months after baseline | |
| Secondary | Work satisfaction | Change from baseline in self-reported work satisfaction will be assessed by a single item (response format from 0-10). | Will be assessed at baseline and after 6 and 12 months. | |
| Secondary | Work ability index (WAI) | Change from baseline in self-reported work ability as assessed by two items from WAI (response format from 1-5). The items relate to perceived capacity to work relative to the physical (1 item) and mental (1 item) demands of the work. | Will be assessed at baseline and after 6 and 12-months of study inclusion. | |
| Secondary | Sickness presenteeism | Change from baseline in sickness presenteeism is assessed with a single question (response format from 1-4). | Will be assessed at baseline and after 6 and 12-months of study inclusion. | |
| Secondary | The Institute of Stress Medicine's instrument for self-rating of stress-related Exhaustion Disorder (s-ED) | Change from baseline in self-reported exhaustion on the s-UMS (two yes/no items and one item with a response format from 0-2. | Will be assessed at baseline and after 6 and 12-months of study inclusion. | |
| Secondary | Maslach Burnout Inventory - General Survey, Exhaustion-scale | Change from baseline in self-reported exhaustion as assessed by the MBI-GS's exhaustion scale (response format from 0 to 6). | Will be assessed at baseline and after 6 and 12-months of study inclusion. | |
| Secondary | Hospital Anxiety and Depression Scale | Change from baseline in self-reported mental health as assessed by the Hospital Anxiety and Depression Scale (response format from 0-3). | Will be assessed at baseline and after 6 and 12-months of study inclusion. | |
| Secondary | Self-perceived health | Change from baseline in self-perceived health will be assessed with a single question (response format from 1-5). | Will be assessed at baseline and after 6 and 12-months of study inclusion. | |
| Secondary | European Quality of Life - 5 Dimensions questionnaire (EQ-5D) | Change from baseline in self-assessed health as assessed by EQ-5D (response format from 1-3). | Will be measured at baseline and after 6 and 12-months of study inclusion. | |
| Secondary | Self-reported stress | Change from baseline in self-reported stress as assessed by a single item (response format from 1-5). | At baseline and every other month (eighth weeks intervals) during a follow-up period of 12 months | |
| Secondary | Karolinska Sleep Questionnaire, Insomnia sub-scale | Change from baseline in self-assessed sleeping problems as assessed by the Insomnia subscale of the Karolinska Sleep Questionnaire (response format from 1-6). | Will be measured at baseline and after 6 and 12-months of study inclusion. | |
| Secondary | Demand-control-support model. Prognostic variable. | Change from Baseline at 6 and 12 months (response format from 1-4). | Baseline and at 6 and 12 months of study inclusion | |
| Secondary | 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. | Change from baseline at 6 and 12 months after baseline (Likert-type scales with 3 to 5 response options). | Baseline and at 6 months after study inclusion | |
| Secondary | Physical activity. Prognostic variable. | Physical activity will be assessed by a single item. Response options: 0 minutes, less than 30 minutes, 30-60 minutes, 60-90 minutes, 90-120 minutes or more than 120 minutes. | At 6 and 12 months after intervention | |
| Secondary | Change in work conditions. Prognostic variable. | Possible changes to the participant's work conditions will be asked by a single item with 12 choices. | At 6 and 12 months after intervention | |
| Secondary | Change in the organization. Prognostic variable. | Possible changes in the organization over the past six months are assessed with four response options. | At 6 and 12 months after intervention | |
| Secondary | 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. | These items referred to aspects such as quality of the communication with the OHS personnel, relevance of the intervention, perceived problem-solving skills learned during the intervention, planned adjustments at work, agreement with the supervisor, the implementation of planned adjustments, if follow-up contacts with the OHS have been undertaken and questions regarding treatment satisfaction). | Will be assessed 6 months after intervention. | |
| Secondary | OHS staff's adherence to the intervention (process evaluation data) | Self-reported data, single items. | Assessed at the end of the 12-18 months long recruitment period | |
| Secondary | Implementation of the intervention and entire research project at the OHS units (process evaluation data) | Self-report data, single items and focus group interviews | Assessed at the end of the 12-18 months long recruitment period | |
| Secondary | Three years follow-up: Change from Baseline in registered sickness absenteeism during a 3-year follow-up period | Total sick leave in days, register data (sickness benefit and disability pension).
The analyses will be conducted in accordance with the 12-month follow-up. |
At baseline and 3 years after baseline. |