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

NCT06799403 | Recruiting

• 1 other identifier: 1-10-72-108-24
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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.

Conditions

Work-Related Stress

Keywords

work-related stress; online intervention; group intervention; return-to-work

Outcome Measures

Primary Outcomes (3)

• Perceived stress (T1)

  Self-report measure using the 10 item Perceived Stress Scale (PSS-10), 10 items on a 0-4 scale, ranging from 0-40 point with higher scores indicating more perceived stress.

  Post intervention: 3 months from baseline

• Obejctive cognitive functioning measures by ICAT (T2)

  ICAT (Internet-Based Cognitive Assessment Tool) comprises 5 subtests (list learning, consonant repitition, letter-number sequencing, delayed list learning, visuomotor tracking)

  Follow-up: 6 months from baseline

• Return-to-work

  Derived from the Danish national DREAM registry, comprising information on weekly transfer income (e.g. long-term sickness absence) and employment status

  Participants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-up

Secondary Outcomes (8)

• Perceived Stress (T2)

  Follow-up: 6 months from baseline

• Perceived Stress (T3)

  Follow-up: 12 months from baseline

• Cognitive functioning (T1)

  Post intervention: 3 months from baseline

• Working environment (T1)

  Post intervention: 3 months from baseline

• Working environment (T2)

  Follow-up: 6 months from baseline

Other Outcomes (13)

• Utilizations of psychotropic drug prescriptions

  Participants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-up

• Working environment (T3)

  Follow-up: 12 months from baseline

• Cognitive functioning (T2)

  Follow-up: 6 months from baseline

Study Arms (2)

Therapist-assisted online delivery format

EXPERIMENTAL

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.

Behavioral: Therapist-assisted online stress management

Group-based face-to-face delivery format

ACTIVE COMPARATOR

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

Behavioral: Group-based face-to-face stress management

Interventions

Therapist-assisted online stress management 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.

Also known as: Stop for Stress

Therapist-assisted online delivery format

Group-based face-to-face stress management 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

Also known as: MARS

Group-based face-to-face delivery format

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lea Nørgaard Sørensen: lead
• Gødstrup Hospital: collaborator

Study Sites (2)

Department of Occupational and Environmental Medicine, Aarhus University Hospital

Aarhus, Central Region Denmark, 8200, Denmark

RECRUITING

Department of Occupational and Environmental Medicine, Gødstrup Hospital

Herning, Central Region Denmark, 7400, Denmark

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 21057736 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Occupational Stress

Interventions

Mars

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Planets; Solar System; Astronomical Objects; Astronomical Phenomena; Physical Phenomena

Study Officials

• Zara A Stokholm, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lea N Sørensen, MSc Psychology

CONTACT

+45 61369464; leanso@rm.dk

Zara A Stokholm, MD, PhD

CONTACT

+45 61369464; zarastok@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: March 27, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)