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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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ClinicalTrials.gov Identifier: NCT02563743
Recruitment Status : Active, not recruiting
First Posted : September 30, 2015
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Gunnar Bergström, 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.


Condition or disease Intervention/treatment Phase
Common Mental Disorders and/or Stress Related Symptoms Behavioral: Problem-solving based intervention Behavioral: Treatment as usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2015
Actual Primary Completion Date : June 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Problem-solving based intervention
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.

Active Comparator: 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.
Behavioral: Treatment as usual
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 Measures :
  1. Change from Baseline in total registered sickness absenteeism during the 12 month follow-up period. [ Time Frame: 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 :
  1. Change from baseline in self-reported sickness absenteeism during the 12 months follow-up period [ Time Frame: 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.


  2. The prevalence of no sick leave, part-time sick leave and full-time sick leave during the 12 months follow-up period following baseline [ Time Frame: 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

  3. Among those sick listed at baseline: Time to full Return to Work (RTW) during a follow-up period of 12 months [ Time Frame: 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.

  4. Among those sick listed at baseline: Time to Return to Work (RTW) during a follow-up period of 12 months [ Time Frame: 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.

  5. Work performance impairment due to health problems [ Time Frame: 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).

  6. Work performance impairment due to problems in working environment [ Time Frame: 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).

  7. Cost-effectiveness of the intervention compared to treatment as usual. [ Time Frame: 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).

  8. Work satisfaction [ Time Frame: 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).

  9. Work ability index (WAI) [ Time Frame: 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.

  10. Sickness presenteeism [ Time Frame: 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).

  11. The Institute of Stress Medicine's instrument for self-rating of stress-related Exhaustion Disorder (s-ED) [ Time Frame: 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.

  12. Maslach Burnout Inventory - General Survey, Exhaustion-scale [ Time Frame: 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).

  13. Hospital Anxiety and Depression Scale [ Time Frame: 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).

  14. Self-perceived health [ Time Frame: 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).

  15. European Quality of Life - 5 Dimensions questionnaire (EQ-5D) [ Time Frame: 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).

  16. Self-reported stress [ Time Frame: 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).

  17. Karolinska Sleep Questionnaire, Insomnia sub-scale [ Time Frame: 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).

  18. Demand-control-support model. Prognostic variable. [ Time Frame: Baseline and at 6 and 12 months of study inclusion ]
    Change from Baseline at 6 and 12 months (response format from 1-4).

  19. 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. [ Time Frame: 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).

  20. Physical activity. Prognostic variable. [ Time Frame: 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.

  21. Change in work conditions. Prognostic variable. [ Time Frame: 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.

  22. Change in the organization. Prognostic variable. [ Time Frame: At 6 and 12 months after intervention ]
    Possible changes in the organization over the past six months are assessed with four response options.

  23. 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. [ Time Frame: 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).

  24. OHS staff's adherence to the intervention (process evaluation data) [ Time Frame: Assessed at the end of the 12-18 months long recruitment period ]
    Self-reported data, single items.

  25. Implementation of the intervention and entire research project at the OHS units (process evaluation data) [ Time Frame: Assessed at the end of the 12-18 months long recruitment period ]
    Self-report data, single items and focus group interviews

  26. Three years follow-up: Change from Baseline in registered sickness absenteeism during a 3-year follow-up period [ Time Frame: 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 63 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563743


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden, 14141
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Gunnar Bergström, PhD Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gunnar Bergström, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02563743    
Other Study ID Numbers: 4-2544/2014
2014-0742 ( Other Grant/Funding Number: Swedish Research Council for Health,Working Life and Welfare )
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Keywords provided by Gunnar Bergström, Karolinska Institutet:
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
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders