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Early Identification of Persons at Risk for Sick-leave Due to Work-related Stress (TIDAS)

Primary Purpose

Occupation-related Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Questionnaire and feedback
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Occupation-related Stress Disorder focused on measuring work related stress, questionnaire, early identification

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Employed women and men, aged 18 - 64 years
  • Seeking care for:
  • depression
  • anxiety
  • musculoskeletal disorders
  • gastrointestinal and cardio-vascular symptoms
  • other stress-related symptoms

Exclusion Criteria:

  • Currently on sick-leave or have been on sick-leave with doctor's certificate the last month
  • Have been absent from work due to illness more than 7 days the last month (without doctor's certificate)
  • On sickness or activity payments
  • Pregnant women
  • Patients seeking care for:
  • allergy
  • diabetes
  • urinary tract infection
  • infections (whooping cough, tonsillitis)
  • COPD
  • fractures
  • lumps and spots
  • psychiatric diagnoses such as schizophrenia, other psychoses or bipolar diagnoses
  • prolonging of sick-leave certificate
  • check up of chronic disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    Questionnaire and feedback

    Control group

    Arm Description

    Patients that will see a doctor randomized to the intervention group will fill in the Work Stress Questionnaire prior to the visit. The doctor gets the results from the questionnaire and then gives consultation to the patient based on the results.

    Patients that will see a doctor randomized to the control group get the usual treatment/consultation and after the visit fill in the Work Stress Questionnaire.

    Outcomes

    Primary Outcome Measures

    Number of sick-leave days.
    Differences in number of sick-leave days between intervention group and control group.
    Number of periods of sick-leave, full-time or part-time.
    Differences in number of sick-leave periods, full-time or part-time between intervention group and control group.

    Secondary Outcome Measures

    Number of health care treatments.
    Differences in healthcare treatment between the intervention group and the control group.
    Types of health care treatments.
    Differences in healthcare treatment between the intervention group and the control group.
    Number of medicines prescriptions.
    Differences in the use of medicines between the intervention group and the control group.
    Types of medicines prescriptions.
    Differences in the use of medicines between the intervention group and the control group.

    Full Information

    First Posted
    May 20, 2015
    Last Updated
    November 2, 2018
    Sponsor
    Göteborg University
    Collaborators
    Vastra Gotaland Region
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02480855
    Brief Title
    Early Identification of Persons at Risk for Sick-leave Due to Work-related Stress
    Acronym
    TIDAS
    Official Title
    Early Identification of People at Risk for Sick-leave Due to Work-related Stress - A Randomized Controlled Study of People With Mental Disorders and Physical Complaints Consulting Primary Health Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Göteborg University
    Collaborators
    Vastra Gotaland Region

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A vital question for society in general and primary health care in particular is early identification of persons at risk of sickness absence due to work-related stress. Even though both the individual and society can gain a lot from the prevention of absence, not the least since return to work is costly once a person is sick-listed. There is, surprisingly enough, no established method to do this. This project is a randomized controlled study of people with mental disorders and physical complaints consulting primary care. The purpose is to evaluate if a systematic use of early identification of work-related stress, combined with feedback at consultation, at the primary health care centers can prevent sickness absence among employed women and men with common mental disorders and subjective physical health complaints.
    Detailed Description
    There is no method or established practice in primary health care when it comes to the important issue of early identification of people at risk of sickness absence due to work-related stress. But work-related stress is common and can cause ill-health and sick-listing. Therefore it is a vital question for society in general and primary health care in particular finding methods to early identify persons at such risk. Both the individual and society can gain a lot from the prevention of absence, not the least since return to work is costly once a person is sick-listed. Both women and men see a doctor due to the symptoms, and a majority often goes to the primary health care, and this long before sick-listing comes into question. It could very well be that neither patient, nor doctor is aware that the symptoms the patient describes are caused by work and the stress the patient is subject to there. There is, though, a questionnaire, the Work Stress Questionnaire (WSQ), that has been developed to early identify people at risk. The purpose of this randomized controlled trial is to evaluate if systematic use of the WSQ can reduce the number of sick-days twelve months on in women and men consulting a primary health care GP due to physical and mental complaints. The intervention consists of giving the GPs the WSQ as a tool for systematic use to early identify people at risk, and then be able to refer the patients to preventive health care and other measures within the primary health care or the patient's occupational health service. The project will be carried out within the Region Västra Götaland and engage around 40 general practitioners, who will in all recruit 420 participants (210 to intervention group and 210 to control group). A register follow-up on sick-leave, healthcare treatment and the use of medicines will be made 12 months later. Three studies are planned to evaluate the intervention. Yet another study, a focus group study, is planned to make process evaluation of how the participating health care center staff perceive systematic use of the WSQ.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Occupation-related Stress Disorder
    Keywords
    work related stress, questionnaire, early identification

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    271 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Questionnaire and feedback
    Arm Type
    Other
    Arm Description
    Patients that will see a doctor randomized to the intervention group will fill in the Work Stress Questionnaire prior to the visit. The doctor gets the results from the questionnaire and then gives consultation to the patient based on the results.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients that will see a doctor randomized to the control group get the usual treatment/consultation and after the visit fill in the Work Stress Questionnaire.
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire and feedback
    Primary Outcome Measure Information:
    Title
    Number of sick-leave days.
    Description
    Differences in number of sick-leave days between intervention group and control group.
    Time Frame
    12 months after inclusion
    Title
    Number of periods of sick-leave, full-time or part-time.
    Description
    Differences in number of sick-leave periods, full-time or part-time between intervention group and control group.
    Time Frame
    12 months after inclusion
    Secondary Outcome Measure Information:
    Title
    Number of health care treatments.
    Description
    Differences in healthcare treatment between the intervention group and the control group.
    Time Frame
    12 months after inclusion
    Title
    Types of health care treatments.
    Description
    Differences in healthcare treatment between the intervention group and the control group.
    Time Frame
    12 months after inclusion
    Title
    Number of medicines prescriptions.
    Description
    Differences in the use of medicines between the intervention group and the control group.
    Time Frame
    12 months after inclusion
    Title
    Types of medicines prescriptions.
    Description
    Differences in the use of medicines between the intervention group and the control group.
    Time Frame
    12 months after inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Employed women and men, aged 18 - 64 years Seeking care for: depression anxiety musculoskeletal disorders gastrointestinal and cardio-vascular symptoms other stress-related symptoms Exclusion Criteria: Currently on sick-leave or have been on sick-leave with doctor's certificate the last month Have been absent from work due to illness more than 7 days the last month (without doctor's certificate) On sickness or activity payments Pregnant women Patients seeking care for: allergy diabetes urinary tract infection infections (whooping cough, tonsillitis) COPD fractures lumps and spots psychiatric diagnoses such as schizophrenia, other psychoses or bipolar diagnoses prolonging of sick-leave certificate check up of chronic disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kristina Holmgren, Docent
    Organizational Affiliation
    Section for Rehabilitation and Health, Inst for neuro science and physiology, Sahlgrenska academy, University of Gothenburg
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35484592
    Citation
    Hulten AM, Bjerkeli P, Holmgren K. Work-related stress and future sick leave in a working population seeking care at primary health care centres: a prospective longitudinal study using the WSQ. BMC Public Health. 2022 Apr 28;22(1):851. doi: 10.1186/s12889-022-13269-8.
    Results Reference
    derived
    PubMed Identifier
    33753430
    Citation
    Hulten AM, Bjerkeli P, Holmgren K. Self-reported sick leave following a brief preventive intervention on work-related stress: a randomised controlled trial in primary health care. BMJ Open. 2021 Mar 22;11(3):e041157. doi: 10.1136/bmjopen-2020-041157.
    Results Reference
    derived
    PubMed Identifier
    32917138
    Citation
    Hulten AM, Dahlin-Ivanoff S, Holmgren K. Positioning work related stress - GPs' reasoning about using the WSQ combined with feedback at consultation. BMC Fam Pract. 2020 Sep 11;21(1):187. doi: 10.1186/s12875-020-01258-y.
    Results Reference
    derived
    PubMed Identifier
    32631243
    Citation
    Sandheimer C, Hedenrud T, Hensing G, Holmgren K. Effects of a work stress intervention on healthcare use and treatment compared to treatment as usual: a randomised controlled trial in Swedish primary healthcare. BMC Fam Pract. 2020 Jul 6;21(1):133. doi: 10.1186/s12875-020-01210-0.
    Results Reference
    derived
    PubMed Identifier
    32334516
    Citation
    Bjerkeli PJ, Skoglund I, Holmgren K. Does early identification of high work related stress affect pharmacological treatment of primary care patients? - analysis of Swedish pharmacy dispensing data in a randomised control study. BMC Fam Pract. 2020 Apr 25;21(1):70. doi: 10.1186/s12875-020-01140-x.
    Results Reference
    derived
    PubMed Identifier
    31412832
    Citation
    Holmgren K, Hensing G, Bultmann U, Hadzibajramovic E, Larsson MEH. Does early identification of work-related stress, combined with feedback at GP-consultation, prevent sick leave in the following 12 months? a randomized controlled trial in primary health care. BMC Public Health. 2019 Aug 14;19(1):1110. doi: 10.1186/s12889-019-7452-3.
    Results Reference
    derived
    PubMed Identifier
    27884137
    Citation
    Holmgren K, Sandheimer C, Mardby AC, Larsson ME, Bultmann U, Hange D, Hensing G. Early identification in primary health care of people at risk for sick leave due to work-related stress - study protocol of a randomized controlled trial (RCT). BMC Public Health. 2016 Nov 25;16(1):1193. doi: 10.1186/s12889-016-3852-9.
    Results Reference
    derived

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    Early Identification of Persons at Risk for Sick-leave Due to Work-related Stress

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