Stress in Working Life

NCT ID: NCT05791461

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Occupational Stress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Intervention cohort

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.

MARS (Measures Against Work-related Stress)

Intervention Type BEHAVIORAL

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.

Comparison cohort

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lotte N Andersen, PhD

Role: STUDY_CHAIR

University of Southern Denmark

Locations

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Department of Occupational and Environmental Medicine

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Charlotte B Bond, MSc

Role: CONTACT

65 50 39 77

Lotte N Andersen, PhD

Role: CONTACT

Facility Contacts

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Lars Brandt, PhD

Role: primary

Other Identifiers

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IOB_SDU_CBB_LNA

Identifier Type: -

Identifier Source: org_study_id

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