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
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
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
NCT ID
NCT02480855
First Posted
May 20, 2015
Last Updated
November 2, 2018
Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
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
Learn more about this trial
Early Identification of Persons at Risk for Sick-leave Due to Work-related Stress
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