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Work-Related StressNCT06799403

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

A study testing Therapist-assisted online stress management and Group-based face-to-face stress management in people with Work-Related Stress, run by Lea Nørgaard Sørensen at 2 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Work-Related Stress
What is being tested?
Therapist-assisted online stress management and Group-based face-to-face stress management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
2 sitesDenmark
Study dates
27 Mar 2025to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lea N Sørensen, MSc Psychology contact

+45 61369464

leanso@rm.dk

Zara A Stokholm, MD, PhD contact

+45 61369464

zarastok@rm.dk

Denmark2 sites, 2 recruiting

  • Department of Occupational and Environmental Medicine, Aarhus University Hospital

    Aarhus, Central Region Denmark, 8200

    Lea N Sørensen, MSc Psychology, +45 61369464, leanso@rm.dk

    Zara A Stokholm, MD, PhD, +45 61369464, zarastok@rm.dk

    Recruiting

  • Department of Occupational and Environmental Medicine, Gødstrup Hospital

    Herning, Central Region Denmark, 7400

    Marianne Kyndi, MD, PhD, +45 20949919, marianne.kyndi@rm.dk

    Not yet recruiting

Other trials in Denmark

About this study

Official title: Stop for Stress - En Sammenligning af Online og Gruppebaseret Behandling for Arbejdsrelateret Stress

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.

Being tested
Therapist-assisted online stress management, Group-based face-to-face stress management
Keywords
work-related stress, online intervention, group intervention, return-to-work
Medical subject headings
Occupational Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapist-assisted online stress managementBehavioural

    Also called Stop for Stress

    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 stress managementBehavioural

    Also called MARS

    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

Study groups in NCT06799403
Study groupRoleWhat they receive
Therapist-assisted online delivery formatExperimentalParticipants 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.
Receives: Behavioral: Therapist-assisted online stress management
Group-based face-to-face delivery formatActive comparatorThe 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
Receives: Behavioral: Group-based face-to-face stress management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Post intervention: 3 months from baseline

  2. 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)

    Measured: Follow-up: 6 months from baseline

  3. 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

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

Secondary outcomes (8)

  1. Perceived Stress (T2)

    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.

    Measured: Follow-up: 6 months from baseline

  2. Perceived Stress (T3)

    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.

    Measured: Follow-up: 12 months from baseline

  3. Cognitive functioning (T1)

    Self-report measure using the Cognitive Failures Questionnaire (CFQ), 25 items on a 0-4 point scale, range 0-100 with higher scores indicating lower subjective cognitive functioning.

    Measured: Post intervention: 3 months from baseline

  4. Working environment (T1)

    Perceived working environment self-reported using selected (independent) items from the Danish Psychosocial Questionnaire (DPQ). Includes influence, predictability, work load, relations to coworkers, relations to managers, recognition, and meaning.

    Measured: Post intervention: 3 months from baseline

  5. Working environment (T2)

    Perceived working environment self-reported using selected (independent) items from the Danish Psychosocial Questionnaire (DPQ). Includes influence, predictability, work load, relations to coworkers, relations to managers, recognition, and meaning.

    Measured: Follow-up: 6 months from baseline

  6. Work ability (T1)

    Self-report measure using the Work Ability Index (WAI), 1 item scale ranging from 0-10 with higher scores indicating better work ability

    Measured: Post intervention: 3 months from baseline

  7. Work ability (T2)

    Self-report measure using the Work Ability Index (WAI), 1 item scale ranging from 0-10 with higher scores indicating better work ability

    Measured: Follow-up: 6 months from baseline

  8. Work ability (T3)

    Self-report measure using the Work Ability Index (WAI), 1 item scale ranging from 0-10 with higher scores indicating better work ability

    Measured: Follow-up: 12 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2025
  2. Study start27 Mar 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06799403
Sponsor's protocol ID
1-10-72-108-24
Status last verified
Jun 2025
First submitted
23 Jan 2025
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21057736

Questions about this trial

What is this clinical trial studying?

A study testing Therapist-assisted online stress management and Group-based face-to-face stress management in people with Work-Related Stress, run by Lea Nørgaard Sørensen at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lea N Sørensen, MSc Psychology (+45 61369464, leanso@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived stress (T1) (time frame: Post intervention: 3 months from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06799403, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.

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