Clinical Trial

Stress in Working Life

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Record status
This record was last updated April 3, 2025 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-03-16.
Trial Details
NCT Number NCT05791461
Lead Sponsor University of Southern Denmark
Collaborators: Odense University Hospital
Conditions Occupational Stress
Enrollment 500 participants
Start Date 2023-02-01
Primary Completion 2025-06 (estimated)
Study Completion 2025-07 (estimated)
Updated on ClinicalTrials.gov 2025-04-03