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Stop for Stress - a Randomized Controlled Trial Comparing an Online and a Group-based Format of an Intervention for Work-related Stress

NCT06799403 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-06-17

No results posted yet for this study

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.

Conditions

  • Work-Related Stress

Interventions

BEHAVIORAL

Therapist-assisted online stress management

Participants gain access to an online program comprised by 14 modules covering psychoeducation on stress, sleep, and communication, cognitive behavioral restructuring, and exercises and tools for dealing with stress and preventing relapse. Participants are followed by a therapist providing feedback on exercises and progress. The program extends over approx. 12 weeks.

BEHAVIORAL

Group-based face-to-face stress management

The group-based format consists of 8 sessions of each 3 hours spread across 12 weeks. The sessions cover psychoeducation on stress, sleep, and communication, cognitive behavioral restructuring, and exercises and tools for dealing with stress and preventing relaps. A group includes 8-9 participants

Sponsors & Collaborators

  • Gødstrup Hospital

    collaborator OTHER

  • Lea Nørgaard Sørensen

    lead OTHER

Principal Investigators

  • Zara A Stokholm, MD, PhD · Department of Occupational and Environmental Medicine, Danish Ramazzini Centre, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2027-01-31
Completion
2027-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06799403 on ClinicalTrials.gov