Occupational StressNCT05791461
Stress in Working Life
An observational study of Occupational Stress, run by University of Southern Denmark at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occupational Stress
- What is being tested?
- MARS (Measures Against Work-related Stress)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2023to Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Occupational and Environmental Medicine
Odense, 5000
Lars Brandt, PhD, 30513119, lars.brandt@rsyd.dk
About this study
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
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.
Read more
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.
- Conditions
- Occupational Stress
- Being tested
- MARS (Measures Against Work-related Stress)
- Keywords
- Occupational stress, Cognitive behavioural therapy, Realist evaluation
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARS (Measures Against Work-related Stress)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MARS (Measures Against Work-related Stress) | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months after first contact with clinic.
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.
Measured: 36 months after first contact with clinic.
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.
Measured: Up to 12 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Feb 2023
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Lotte N Andersen, PhD, Study chair, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791461
- Sponsor's protocol ID
- IOB_SDU_CBB_LNA
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05791461
- Acronym / sponsor ID
- IOB_SDU_CBB_LNA
- Conditions
- Occupational Stress
- Keywords
- Occupational stress, Cognitive behavioural therapy, Realist evaluation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention cohort | – | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention cohort |
Primary outcome
The effect of the stress management intervention on sustainable return to work (RTW).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lotte N Andersen, PhD study chair
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Stress, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte B Bond, MSc (65 50 39 77, cbbond@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of the stress management intervention on sustainable return to work (RTW). (time frame: 36 months after first contact with clinic.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.