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

Last Updated: 2025-06-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-27

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Work-Related Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Therapist-assisted online delivery format

Participants will 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.

Group Type EXPERIMENTAL

Therapist-assisted online stress management

Intervention Type BEHAVIORAL

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.

Group-based face-to-face delivery format

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

Group Type ACTIVE_COMPARATOR

Group-based face-to-face stress management

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Stop for Stress MARS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gødstrup Hospital

OTHER

Sponsor Role collaborator

Lea Nørgaard Sørensen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lea Nørgaard Sørensen

PhD student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zara A Stokholm, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Occupational and Environmental Medicine, Danish Ramazzini Centre, Aarhus University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Occupational and Environmental Medicine, Aarhus University Hospital

Aarhus, Central Region Denmark, Denmark

Site Status RECRUITING

Department of Occupational and Environmental Medicine, Gødstrup Hospital

Herning, Central Region Denmark, Denmark

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lea N Sørensen, MSc Psychology

Role: CONTACT

+45 61369464

Zara A Stokholm, MD, PhD

Role: CONTACT

+45 61369464

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lea N Sørensen, MSc Psychology

Role: primary

+45 61369464

Zara A Stokholm, MD, PhD

Role: backup

+45 61369464

Marianne Kyndi, MD, PhD

Role: primary

+45 20949919

References

Explore related publications, articles, or registry entries linked to this study.

Willert MV, Thulstrup AM, Bonde JP. Effects of a stress management intervention on absenteeism and return to work--results from a randomized wait-list controlled trial. Scand J Work Environ Health. 2011 May;37(3):186-95. doi: 10.5271/sjweh.3130. Epub 2010 Nov 8.

Reference Type BACKGROUND
PMID: 21057736 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://stopforstress.auh.dk

Danish project website that inform potentional participant and general practitioners about the aim of the study, who can participate, and what is expected of participants.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1-10-72-108-24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Strategies for Responding to Stress
NCT03289156 COMPLETED NA
Understanding Everyday Stress
NCT05502575 COMPLETED PHASE2