Skip to main content
OpenTrials
Completed

NCT Number: NCT02563743

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Common Mental Disorders and/or Stress Related Symptoms Adjustment Disorders Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Occupational Diseases Occupational Stress Stress, Psychological Trauma and Stressor Related Disorders

Age range

18 year–63 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 14141, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Problem-solving based intervention

Behavioral

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.

Treatment as Usual

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Sep 30, 2015
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.