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

Primary Purpose

Common Mental Disorders and/or Stress Related Symptoms

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Problem-solving based intervention
Treatment as usual
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Mental Disorders and/or Stress Related Symptoms focused on measuring 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

Eligibility Criteria

18 Years - 63 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Problem-solving based intervention

Treatment as usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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.
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.
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).
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).
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).
Work satisfaction
Change from baseline in self-reported work satisfaction will be assessed by a single item (response format from 0-10).
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.
Sickness presenteeism
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)
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.
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).
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).
Self-perceived health
Change from baseline in self-perceived health will be assessed with a single question (response format from 1-5).
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).
Self-reported stress
Change from baseline in self-reported stress as assessed by a single item (response format from 1-5).
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).
Demand-control-support model. Prognostic variable.
Change from Baseline at 6 and 12 months (response format from 1-4).
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).
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.
Change in work conditions. Prognostic variable.
Possible changes to the participant's work conditions will be asked by a single item with 12 choices.
Change in the organization. Prognostic variable.
Possible changes in the organization over the past six months are assessed with four response options.
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).
OHS staff's adherence to the intervention (process evaluation data)
Self-reported data, single items.
Implementation of the intervention and entire research project at the OHS units (process evaluation data)
Self-report data, single items and focus group interviews
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.

Full Information

First Posted
September 21, 2015
Last Updated
September 5, 2021
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02563743
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 25, 2015 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem-solving based intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Problem-solving based intervention
Intervention Description
The intervention comprises both the employee and the employer, and follows a clear structure comprising problem solving, stepwise activation and relapse prevention. It includes three meetings at the OHS with additional follow-ups.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Study participants that are randomized into the control group will receive the usual care given at the OHS. This intervention will differ due to differences between the OHS units.
Primary Outcome Measure Information:
Title
Change from Baseline in total registered sickness absenteeism during the 12 month follow-up period.
Description
(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
Time Frame
At baseline and 12 months after baseline.
Secondary Outcome Measure Information:
Title
Change from baseline in self-reported sickness absenteeism during the 12 months follow-up period
Description
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.
Time Frame
At baseline and during monthly follow-ups for a period of 12 months
Title
The prevalence of no sick leave, part-time sick leave and full-time sick leave during the 12 months follow-up period following baseline
Description
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
Time Frame
Twelve months after baseline
Title
Among those sick listed at baseline: Time to full Return to Work (RTW) during a follow-up period of 12 months
Description
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.
Time Frame
At baseline and during monthly follow-ups for a period of 12 months
Title
Among those sick listed at baseline: Time to Return to Work (RTW) during a follow-up period of 12 months
Description
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.
Time Frame
At baseline and during monthly follow-ups for a period of 12 months
Title
Work performance impairment due to health problems
Description
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).
Time Frame
Will be assessed at baseline and once a month during a 12-month follow-up period
Title
Work performance impairment due to problems in working environment
Description
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).
Time Frame
Will be assessed at baseline and every other month (eighth weeks intervals) during a 12-month follow-up period
Title
Cost-effectiveness of the intervention compared to treatment as usual.
Description
The cost-effectiveness of the intervention will be calculated with regard to production loss (sick leave and performance while at work).
Time Frame
At 12 months after baseline
Title
Work satisfaction
Description
Change from baseline in self-reported work satisfaction will be assessed by a single item (response format from 0-10).
Time Frame
Will be assessed at baseline and after 6 and 12 months.
Title
Work ability index (WAI)
Description
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.
Time Frame
Will be assessed at baseline and after 6 and 12-months of study inclusion.
Title
Sickness presenteeism
Description
Change from baseline in sickness presenteeism is assessed with a single question (response format from 1-4).
Time Frame
Will be assessed at baseline and after 6 and 12-months of study inclusion.
Title
The Institute of Stress Medicine's instrument for self-rating of stress-related Exhaustion Disorder (s-ED)
Description
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.
Time Frame
Will be assessed at baseline and after 6 and 12-months of study inclusion.
Title
Maslach Burnout Inventory - General Survey, Exhaustion-scale
Description
Change from baseline in self-reported exhaustion as assessed by the MBI-GS's exhaustion scale (response format from 0 to 6).
Time Frame
Will be assessed at baseline and after 6 and 12-months of study inclusion.
Title
Hospital Anxiety and Depression Scale
Description
Change from baseline in self-reported mental health as assessed by the Hospital Anxiety and Depression Scale (response format from 0-3).
Time Frame
Will be assessed at baseline and after 6 and 12-months of study inclusion.
Title
Self-perceived health
Description
Change from baseline in self-perceived health will be assessed with a single question (response format from 1-5).
Time Frame
Will be assessed at baseline and after 6 and 12-months of study inclusion.
Title
European Quality of Life - 5 Dimensions questionnaire (EQ-5D)
Description
Change from baseline in self-assessed health as assessed by EQ-5D (response format from 1-3).
Time Frame
Will be measured at baseline and after 6 and 12-months of study inclusion.
Title
Self-reported stress
Description
Change from baseline in self-reported stress as assessed by a single item (response format from 1-5).
Time Frame
At baseline and every other month (eighth weeks intervals) during a follow-up period of 12 months
Title
Karolinska Sleep Questionnaire, Insomnia sub-scale
Description
Change from baseline in self-assessed sleeping problems as assessed by the Insomnia subscale of the Karolinska Sleep Questionnaire (response format from 1-6).
Time Frame
Will be measured at baseline and after 6 and 12-months of study inclusion.
Title
Demand-control-support model. Prognostic variable.
Description
Change from Baseline at 6 and 12 months (response format from 1-4).
Time Frame
Baseline and at 6 and 12 months of study inclusion
Title
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.
Description
Change from baseline at 6 and 12 months after baseline (Likert-type scales with 3 to 5 response options).
Time Frame
Baseline and at 6 months after study inclusion
Title
Physical activity. Prognostic variable.
Description
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.
Time Frame
At 6 and 12 months after intervention
Title
Change in work conditions. Prognostic variable.
Description
Possible changes to the participant's work conditions will be asked by a single item with 12 choices.
Time Frame
At 6 and 12 months after intervention
Title
Change in the organization. Prognostic variable.
Description
Possible changes in the organization over the past six months are assessed with four response options.
Time Frame
At 6 and 12 months after intervention
Title
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.
Description
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).
Time Frame
Will be assessed 6 months after intervention.
Title
OHS staff's adherence to the intervention (process evaluation data)
Description
Self-reported data, single items.
Time Frame
Assessed at the end of the 12-18 months long recruitment period
Title
Implementation of the intervention and entire research project at the OHS units (process evaluation data)
Description
Self-report data, single items and focus group interviews
Time Frame
Assessed at the end of the 12-18 months long recruitment period
Title
Three years follow-up: Change from Baseline in registered sickness absenteeism during a 3-year follow-up period
Description
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.
Time Frame
At baseline and 3 years after baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Bergström, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
14141
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28494753
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.
Results Reference
background
PubMed Identifier
32291291
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.
Results Reference
background
PubMed Identifier
32698470
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.
Results Reference
background

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

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