Clinical trial NCT05791461: Stress in Working Life
Official title: Stress in Working Life - Realist Evaluation of a Stress Management Intervention for Patients Referred to an Occupational Health Clinic Due to Work-related Stress
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Occupational Stress
Keywords: Occupational stress
Cognitive behavioural therapy
Realist evaluation
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2023-03-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with work-related stress (diagnoses F43.2/8/9 or Z56.3 (ICD-10)) seen at Department of Occupational and Environmental Medicine, Odense, in the period 2011-2018

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.

Primary outcomes:
measure: The effect of the stress management intervention on sustainable return to work (RTW).
timeFrame: 36 months after first contact with clinic.
measure: Identification of possible contexts and mechanisms associated with patients' RTW rates after having received the stress management intervention.
timeFrame: 36 months after first contact with clinic.
measure: From a patient perspective how mechanisms work in specific contexts to generate effects of the stress management intervention.
timeFrame: Up to 12 months after intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Occupational and Environmental Medicine
Study officials:
affiliation: University of Southern Denmark
name: Lotte N Andersen, PhD
role: STUDY_CHAIR
References: