Clinical trial NCT02563743: Stress and Mental Ill-health in the Workplace: Evaluation of an Intervention for the Prevention of Sick Leave
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Mental Disorders and/or Stress Related Symptoms
Keywords: Sick-leave
Return to work
Occupational health
Common mental disorder
Depression
Anxiety disorders
Adjustment disorders
Problem solving therapy
Occupational Health Services
Randomized controlled trial
Intervention studies
Occupational stress
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in total registered sickness absenteeism during the 12 month follow-up period.
timeFrame: At baseline and 12 months after baseline.
Secondary outcomes:
measure: Change from baseline in self-reported sickness absenteeism during the 12 months follow-up period
timeFrame: At baseline and during monthly follow-ups for a period of 12 months
measure: The prevalence of no sick leave, part-time sick leave and full-time sick leave during the 12 months follow-up period following baseline
timeFrame: Twelve months after baseline
measure: Among those sick listed at baseline: Time to full Return to Work (RTW) during a follow-up period of 12 months
timeFrame: At baseline and during monthly follow-ups for a period of 12 months
measure: Among those sick listed at baseline: Time to Return to Work (RTW) during a follow-up period of 12 months
timeFrame: At baseline and during monthly follow-ups for a period of 12 months
measure: Work performance impairment due to health problems
timeFrame: Will be assessed at baseline and once a month during a 12-month follow-up period
measure: Work performance impairment due to problems in working environment
timeFrame: Will be assessed at baseline and every other month (eighth weeks intervals) during a 12-month follow-up period
measure: Cost-effectiveness of the intervention compared to treatment as usual.
timeFrame: At 12 months after baseline
measure: Work satisfaction
timeFrame: Will be assessed at baseline and after 6 and 12 months.
measure: Work ability index (WAI)
timeFrame: Will be assessed at baseline and after 6 and 12-months of study inclusion.
measure: Sickness presenteeism
timeFrame: Will be assessed at baseline and after 6 and 12-months of study inclusion.
measure: The Institute of Stress Medicine's instrument for self-rating of stress-related Exhaustion Disorder (s-ED)
timeFrame: Will be assessed at baseline and after 6 and 12-months of study inclusion.
measure: Maslach Burnout Inventory - General Survey, Exhaustion-scale
timeFrame: Will be assessed at baseline and after 6 and 12-months of study inclusion.
measure: Hospital Anxiety and Depression Scale
timeFrame: Will be assessed at baseline and after 6 and 12-months of study inclusion.
measure: Self-perceived health
timeFrame: Will be assessed at baseline and after 6 and 12-months of study inclusion.
measure: European Quality of Life - 5 Dimensions questionnaire (EQ-5D)
timeFrame: Will be measured at baseline and after 6 and 12-months of study inclusion.
measure: Self-reported stress
timeFrame: At baseline and every other month (eighth weeks intervals) during a follow-up period of 12 months
measure: Karolinska Sleep Questionnaire, Insomnia sub-scale
timeFrame: Will be measured at baseline and after 6 and 12-months of study inclusion.
measure: Demand-control-support model. Prognostic variable.
timeFrame: Baseline and at 6 and 12 months of study inclusion
measure: 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.
timeFrame: Baseline and at 6 months after study inclusion
measure: Physical activity. Prognostic variable.
timeFrame: At 6 and 12 months after intervention
measure: Change in work conditions. Prognostic variable.
timeFrame: At 6 and 12 months after intervention
measure: Change in the organization. Prognostic variable.
timeFrame: At 6 and 12 months after intervention
measure: 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.
timeFrame: Will be assessed 6 months after intervention.
measure: OHS staff's adherence to the intervention (process evaluation data)
timeFrame: Assessed at the end of the 12-18 months long recruitment period
measure: Implementation of the intervention and entire research project at the OHS units (process evaluation data)
timeFrame: Assessed at the end of the 12-18 months long recruitment period
measure: Three years follow-up: Change from Baseline in registered sickness absenteeism during a 3-year follow-up period
timeFrame: At baseline and 3 years after baseline.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Gunnar Bergström, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergstrom G, Lohela-Karlsson M, Kwak L, Bodin L, Jensen I, Torgen 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.
citation: Keus van de Poll M, Nybergh L, Lornudd C, Hagberg J, Bodin L, Kwak L, Jensen I, Lohela-Karlsson M, Torgen 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.
citation: Keus Van De Poll M, Bergstrom 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):5234. doi: 10.3390/ijerph17145234.