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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02480855
Other study ID # TIDAS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date December 2017

Study information

Verified date November 2018
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 271
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Occupation-related Stress Disorder

Intervention

Other:
Questionnaire and feedback


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Göteborg University Vastra Gotaland Region

Outcome

Type Measure Description Time frame Safety issue
Primary Number of sick-leave days. Differences in number of sick-leave days between intervention group and control group. 12 months after inclusion
Primary 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. 12 months after inclusion
Secondary Number of health care treatments. Differences in healthcare treatment between the intervention group and the control group. 12 months after inclusion
Secondary Types of health care treatments. Differences in healthcare treatment between the intervention group and the control group. 12 months after inclusion
Secondary Number of medicines prescriptions. Differences in the use of medicines between the intervention group and the control group. 12 months after inclusion
Secondary Types of medicines prescriptions. Differences in the use of medicines between the intervention group and the control group. 12 months after inclusion
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