Stress in Working Life

Recruiting

• Conditions: Occupational Stress
• Interventions: Behavioral: MARS (Measures Against Work-related Stress)

• Registration Number: NCT05791461
• Lead Sponsor: University of Southern Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention cohort	MARS (Measures Against Work-related Stress)	Patients with work-related stress (F43.2/8/9 or Z56.3 (ICD-0)) who received the stress management intervention between 2011-2018 (N\>400). The intervention is based on cognitive behavioral therapy, delivered by a trained psychologist in groups of 8-10 patients. The intervention consists of 8 sessions in 3 months, with a booster session 3 months after the intervention has ended.

Primary Outcome Measures

Name	Time	Method
The effect of the stress management intervention on sustainable return to work (RTW).	36 months after first contact with clinic.	The primary outcome is sustainable RTW which is defined as returning to full-time work for a minimum of four months without any sick-leave compensation. Data from the DREAM database (national database containing information about sick leave compensation in the Danish population) will be obtained for both the intervention cohort and the comparison cohort for the two-year period prior to the first consultation at Department of Occupational and Environmental Medicine, Odense, and for three years after.
Identification of possible contexts and mechanisms associated with patients' RTW rates after having received the stress management intervention.	36 months after first contact with clinic.	Data on sick leave compensation from the DREAM database.
From a patient perspective how mechanisms work in specific contexts to generate effects of the stress management intervention.	Up to 12 months after intervention.	From realist theory driven interviews patient-reported context-mechanism -outcome-configurations will be used to refine, confirm or refute the initial program theory.

Trial Locations

Locations (1)

Department of Occupational and Environmental Medicine; 🇩🇰 Odense, Denmark