| NCT ID | NCT05791461 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Southern Denmark |
| Condition | Occupational Stress |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-02-01 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this realist evaluation of a Danish Cognitive Behavioral Therapy (CBT)-based stress management for patients with work-related stress is to understand what works, for whom, in what circumstances.The main objectives are: To assess the effect of the stress management intervention on sustainable return to work. To investigate what contexts and mechanisms are associated with patients' return to work rates and level of perceived stress after having received the stress management intervention. To understand from a patient perspective how mechanisms work in specific contexts to generate effects of the stress management intervention. The evaluation comprises two observational studies and one interview study. The intervention cohort are patients with work-related stress who received the stress management intervention between 2012-2018. The comparison cohort are patients who would have been eligible to receive the intervention in 2011-2012, however they did not receive any intervention because it was not offered at that time. In study one return to work rates are compared between the intervention cohort and the comparison cohort to find out if the intervention can help patients return to work at a faster rate. Study two will investigate if there are any explanatory variables (such as work type, civil status or level of depressive symptoms) that may explain why some patients benefit more or less from the intervention. Study three will explore what it is about the intervention (mechanisms) the patients find are helping them to cope with stress or the opposite in specific circumstances.
Eligibility Criteria
Inclusion Criteria: * exposure to stressful conditions at work such as a large workload and/or stressful organisational and managerial conditions. * Patients must be employed, and if on sick leave there must be plans for return to work during the intervention period. * Patients must exhibit severe signs of work-related stress meaning that there must have been a significant work-related impact, the patient must have had physical, psychological, and behavioural stress symptoms for more than four weeks. Exclusion Criteria: * patient's work-related stress is primarily caused by cooperation problems, bullying and/or harassment, * long-term sick leave \>26 weeks up to referral * more severe stress load outside of work * severe psychiatric conditions that requires treatment * current abuse of alcohol and/or psychoactive stimulants.
Contact & Investigator
Lotte N Andersen, PhD
STUDY CHAIR
University of Southern Denmark
Frequently Asked Questions
Who can join the NCT05791461 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Occupational Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05791461 currently recruiting?
Yes, NCT05791461 is actively recruiting participants. Contact the research team at cbbond@health.sdu.dk for enrollment information.
Where is the NCT05791461 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT05791461 clinical trial?
NCT05791461 is sponsored by University of Southern Denmark. The principal investigator is Lotte N Andersen, PhD at University of Southern Denmark. The trial plans to enroll 500 participants.