Stress in Working Life

University of Southern Denmark (SDU)

Status: Enrolling

Conditions: Occupational Stress

Treatments: Behavioral: MARS (Measures Against Work-related Stress)

Study type: Observational

Funder types: Other

Identifiers

NCT05791461

IOB_SDU_CBB_LNA

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Intervention cohort

Description:

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.

Treatment:

Behavioral: MARS (Measures Against Work-related Stress)

Comparison cohort

Description:

Patients with work-related stress (diagnoses F43.2/8/9 or Z56.3 (ICD-10)) who was seen at a consultation at Department of Occupational and Environmental Health in Odense (DOEM) in 2011-2012, but did not receive the intervention because it was not yet offered. The patients were offered advice and support by a psychologist (usual care). The intervention was introduced at DOEM in 2011 for a limited number of patients due to introducing the intervention and establishing the capacity of psychologists involved. In 2013 the intervention was implemented at full scale to include every eligible patient.