Stress and Mental Ill-health in the Workplace: Evaluation of an Intervention for the Prevention of Sick Leave

Not Applicable

Completed

• Conditions: Common Mental Disorders and/or Stress Related Symptoms
• Interventions: Behavioral: Problem-solving based intervention; Behavioral: Treatment as usual

• Registration Number: NCT02563743
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-08-25
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Primary Completion: 2018-05-30
• Study Completion: 2020-05-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-05
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Problem-solving based intervention	Problem-solving based intervention	Problem-solving based intervention with a participative approach. During the intervention a systematic assessment of the match between the employee and the work environment is considered. The intervention applies a participatory approach where the supervisor and the employee are guided by the OHS consultant and encouraged to actively take part in problem solving concerning the work situation. The intervention consists of three meetings, one between the OHS consultant and a representative for the employer (usually the nearest supervisor), one between the consultant and the employee and then a third meeting where all three parties participate.
Treatment as usual	Treatment as usual	The control intervention consists of the usual interventions given at the participating OHS. These interventions are also work-directed and usually also include participation of both the employee and the supervisor. However, structured problem solving methods and the systematic consideration of the match between the employee and the job situation are not applied. The content of the control condition will vary between different occupational health service units.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in total registered sickness absenteeism during the 12 month follow-up period.	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

Secondary Outcome Measures

Name	Time	Method
Maslach Burnout Inventory - General Survey, Exhaustion-scale	Will be assessed at baseline and after 6 and 12-months of study inclusion.	Change from baseline in self-reported exhaustion as assessed by the MBI-GS's exhaustion scale (response format from 0 to 6).
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	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
Demand-control-support model. Prognostic variable.	Baseline and at 6 and 12 months of study inclusion	Change from Baseline at 6 and 12 months (response format from 1-4).
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	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.
Sickness presenteeism	Will be assessed at baseline and after 6 and 12-months of study inclusion.	Change from baseline in sickness presenteeism is assessed with a single question (response format from 1-4).
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.	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.
European Quality of Life - 5 Dimensions questionnaire (EQ-5D)	Will be measured at baseline and after 6 and 12-months of study inclusion.	Change from baseline in self-assessed health as assessed by EQ-5D (response format from 1-3).
Change in work conditions. Prognostic variable.	At 6 and 12 months after intervention	Possible changes to the participant's work conditions will be asked by a single item with 12 choices.
Work performance impairment due to health problems	Will be assessed at baseline and once a month during a 12-month follow-up period	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).
Work satisfaction	Will be assessed at baseline and after 6 and 12 months.	Change from baseline in self-reported work satisfaction will be assessed by a single item (response format from 0-10).
Self-perceived health	Will be assessed at baseline and after 6 and 12-months of study inclusion.	Change from baseline in self-perceived health will be assessed with a single question (response format from 1-5).
Karolinska Sleep Questionnaire, Insomnia sub-scale	Will be measured at baseline and after 6 and 12-months of study inclusion.	Change from baseline in self-assessed sleeping problems as assessed by the Insomnia subscale of the Karolinska Sleep Questionnaire (response format from 1-6).
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 from baseline at 6 and 12 months after baseline (Likert-type scales with 3 to 5 response options).
Change in the organization. Prognostic variable.	At 6 and 12 months after intervention	Possible changes in the organization over the past six months are assessed with four response options.
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	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.
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	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).
Self-reported stress	At baseline and every other month (eighth weeks intervals) during a follow-up period of 12 months	Change from baseline in self-reported stress as assessed by a single item (response format from 1-5).
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.	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).
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	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.
Cost-effectiveness of the intervention compared to treatment as usual.	At 12 months after baseline	The cost-effectiveness of the intervention will be calculated with regard to production loss (sick leave and performance while at work).
Work ability index (WAI)	Will be assessed at baseline and after 6 and 12-months of study inclusion.	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.
Hospital Anxiety and Depression Scale	Will be assessed at baseline and after 6 and 12-months of study inclusion.	Change from baseline in self-reported mental health as assessed by the Hospital Anxiety and Depression Scale (response format from 0-3).
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.	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.
Physical activity. Prognostic variable.	At 6 and 12 months after intervention	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.
OHS staff's adherence to the intervention (process evaluation data)	Assessed at the end of the 12-18 months long recruitment period	Self-reported data, single items.
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	Self-report data, single items and focus group interviews

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden