Stress in Working Life

Occupational Stress Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05791461
• Other study ID #: IOB_SDU_CBB_LNA
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: July 2025

Study information

• Verified date: March 2023
• Source: University of Southern Denmark
• Contact: Charlotte B Bond, MSc
• Phone: 65 50 39 77
• Email: cbbond[@]health.sdu.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Occupational Stress

Intervention

Behavioral:
• MARS (Measures Against Work-related Stress)
The stress management intervention is based on cognitive behavioral therapy and aims to change the way patients perceive and cope with stressful situations at work. It is group sessions over 3 months with approximately 9 participants. Participants meet 9 times (once a week the first 3 weeks and once every second week the last 5 times) and for a follow-up session 3 months after the intervention has ended. Each session lasts for 3 hours and is led by a trained psychologist. The participants perform tasks at home between the sessions. In the first session the rationale behind the intervention is introduced. In session 2 and 3 the patients work with enhancing self-regulation. In session 4 and 5 the focus is on modifying intermediate beliefs. In session 6 the focus is on improving interaction. Session 7 and 8 focuses on consolidation of learning and strategies to prevent relapse, and session 9 is a follow-up session 3 months after the intervention has ended.

Locations

Country	Name	City	State
Denmark	Department of Occupational and Environmental Medicine	Odense

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of the stress management intervention on sustainable return to work (RTW).	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.	36 months after first contact with clinic.
Primary	Identification of possible contexts and mechanisms associated with patients' RTW rates after having received the stress management intervention.	Data on sick leave compensation from the DREAM database.	36 months after first contact with clinic.
Primary	From a patient perspective how mechanisms work in specific contexts to generate effects of the stress management intervention.	From realist theory driven interviews patient-reported context-mechanism -outcome-configurations will be used to refine, confirm or refute the initial program theory.	Up to 12 months after intervention.