Occupation-related Stress DisorderTIDASNCT02480855
Early Identification of Persons at Risk for Sick-leave Due to Work-related Stress
A study testing Questionnaire and feedback in people with Occupation-related Stress Disorder, run by Göteborg University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Occupation-related Stress Disorder
- What is being tested?
- Questionnaire and feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Employed women and men, aged 18 - 64 years
- Seeking care for:
- depression
- anxiety
- musculoskeletal disorders
- gastrointestinal and cardio-vascular symptoms
- other stress-related symptoms
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
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
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.
Read the 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.
- Conditions
- Occupation-related Stress Disorder
- Being tested
- Questionnaire and feedback
- Keywords
- work related stress, questionnaire, early identification
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and feedbackOther
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire and feedback | Other | 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. Receives: Other: Questionnaire and feedback |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sick-leave days.
Differences in number of sick-leave days between intervention group and control group.
Measured: 12 months after inclusion
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.
Measured: 12 months after inclusion
Secondary outcomes (4)
Number of health care treatments.
Differences in healthcare treatment between the intervention group and the control group.
Measured: 12 months after inclusion
Types of health care treatments.
Differences in healthcare treatment between the intervention group and the control group.
Measured: 12 months after inclusion
Number of medicines prescriptions.
Differences in the use of medicines between the intervention group and the control group.
Measured: 12 months after inclusion
Types of medicines prescriptions.
Differences in the use of medicines between the intervention group and the control group.
Measured: 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Occupation-related Stress DisorderStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Kristina Holmgren, Docent, Principal investigator, Section for Rehabilitation and Health, Inst for neuro science and physiology, Sahlgrenska academy, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480855
- Sponsor's protocol ID
- TIDAS
- Acronym
- TIDAS
- Status last verified
- Nov 2018
- First submitted
- 20 May 2015
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35484592Hulten 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.
PubMed 33753430Hulten 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.
PubMed 32917138Sandheimer 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.
PubMed 32631243Bjerkeli 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.
PubMed 32334516Holmgren 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.
PubMed 31412832Holmgren 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.
PubMed 27884137
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02480855
- Acronym / sponsor ID
- TIDAS / TIDAS
- Conditions
- Occupation-related Stress Disorder
- Keywords
- work related stress, questionnaire, early identification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Questionnaire and feedback | Other | Other: Questionnaire and feedbackPatients 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Employed women and men, aged 18 - 64 years
- Seeking care for:
- depression
- anxiety
- musculoskeletal disorders
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and feedback | Other | Questionnaire and feedback |
Primary outcome
Number of sick-leave days.
Time frame: 12 months after inclusion
Differences in number of sick-leave days between intervention group and control group.
Number of periods of sick-leave, full-time or part-time.
Time frame: 12 months after inclusion
Differences in number of sick-leave periods, full-time or part-time between intervention group and control group.
4 secondary outcomes
Number of health care treatments.
Time frame: 12 months after inclusion
Types of health care treatments.
Time frame: 12 months after inclusion
Number of medicines prescriptions.
Time frame: 12 months after inclusion
Types of medicines prescriptions.
Time frame: 12 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Derived from this study: PubMed 35484592Hulten 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.
- Derived from this study: PubMed 33753430Hulten 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.
- Derived from this study: PubMed 32917138Hulten 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.
- Derived from this study: PubMed 32631243Sandheimer 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.
- Derived from this study: PubMed 32334516Bjerkeli 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.
- Derived from this study: PubMed 31412832Holmgren 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.
- Derived from this study: PubMed 27884137Holmgren 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Holmgren, Docent principal investigator
Section for Rehabilitation and Health, Inst for neuro science and physiology, Sahlgrenska academy, University of Gothenburg
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and feedback in people with Occupation-related Stress Disorder, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sick-leave days. (time frame: 12 months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02480855, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.