Stress in Working Life

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.

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 Overview

• Status: Recruiting
• Conditions: Occupational Stress
• Intervention / Treatment: Behavioral: MARS (Measures Against Work-related Stress)

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Charlotte B Bond, MSc; Phone Number: 65 50 39 77; Email: cbbond@health.sdu.dk
• Study Contact Backup: Name: Lotte N Andersen, PhD; Phone Number: 65507591; Email: lonygaard@health.sdu.dk

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Recruiting
    • Department of Occupational and Environmental Medicine
    • Contact: Lars Brandt, PhD; Phone Number: 30513119; Email: lars.brandt@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Odense University Hospital
• Investigators: Study Chair: Lotte N Andersen, PhD, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Cognitive behavioural therapy; Occupational stress; Realist evaluation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Occupational Stress
• Other Study ID Numbers: IOB_SDU_CBB_LNA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No