NCT06799403 Stop for Stress - a Randomized Controlled Trial Comparing an Online and a Group-based Format of an Intervention for Work-related Stress
| NCT ID | NCT06799403 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lea Nørgaard Sørensen |
| Condition | Work-Related Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2025-03-27 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Work-related stress is a major public health concern, causing sickness absenteeism and impaired health and well-being. Many afflicted with severe work-related stress will not receive evidence-based treatment due to geographical distance, stigma and unwillingness to participate in a group, creating unequality access to healthcare services. Online interventions show comparable effects to face-to-face interventions and have potential to break down some of these barriers. We have developed and pilot tested the online delivery format of the intervention for work-related stress, Stop for Stress, with promising results. In a two-armed, multicentre randomized controlled trial we aim to 1) compare the effect of the online delivery format and an evidence-based face-to-face group-based format and 2) identify markers of enhanced outcomes in each delivery format. The study will include 220 patients with severe work-related stress (110 from each of two centres) who are randomizes 1:1 to the two interventions. Outcomes consist of self-report measures of psychological symptoms, cognitive functioning, sleep, and perceived working environment and register data on ebsenteeism and return-to-work.
Eligibility Criteria
Inclusion Criteria: * Current employment and significant work-related stressors * Perceived Stress Scale (PSS-10) score ≥20 and symptom duration \>4 weeks * In case of full-time sick leave, return to work must be planned concurrent with the intervention * Access to a computer or tablet with internet connection at home Exclusion Criteria: * Interpersonal difficulties, bullying, harassment, violence, threats, and traumatic events as primary stressor * Severe stressors outside of work * Symptoms meeting diagnostic criteria for anxiety, depression or severe psychiatric illnesses requiring specialized treatment * Current abuse of alcohol and/or psychoactive drugs
Contact & Investigator
Zara A Stokholm, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Occupational and Environmental Medicine, Danish Ramazzini Centre, Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT06799403 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Work-Related Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06799403 currently recruiting?
Yes, NCT06799403 is actively recruiting participants. Contact the research team at leanso@rm.dk for enrollment information.
Where is the NCT06799403 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Herning, Denmark.
Who is sponsoring the NCT06799403 clinical trial?
NCT06799403 is sponsored by Lea Nørgaard Sørensen. The principal investigator is Zara A Stokholm, MD, PhD at Department of Occupational and Environmental Medicine, Danish Ramazzini Centre, Aarhus University Hospital. The trial plans to enroll 220 participants.