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

June 13, 2025 updated by: Lea Nørgaard Sørensen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Lea N Sørensen, MSc Psychology
  • Phone Number: +45 61369464
  • Email: leanso@rm.dk

Study Contact Backup

  • Name: Zara A Stokholm, MD, PhD
  • Phone Number: +45 61369464
  • Email: zarastok@rm.dk

Study Locations

  • Denmark
    • Central Region Denmark
      • Aarhus, Central Region Denmark, Denmark, 8200
        • Recruiting
        • Department of Occupational and Environmental Medicine, Aarhus University Hospital
        • Contact:
          • Lea N Sørensen, MSc Psychology
          • Phone Number: +45 61369464
          • Email: leanso@rm.dk
        • Contact:
          • Zara A Stokholm, MD, PhD
          • Phone Number: +45 61369464
          • Email: zarastok@rm.dk
      • Herning, Central Region Denmark, Denmark, 7400
        • Not yet recruiting
        • Department of Occupational and Environmental Medicine, Gødstrup Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Other Names:
  • Stop for Stress
Active Comparator: 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
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
Other Names:
  • MARS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Return-to-work
Time Frame: Participants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-up
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
Perceived stress (T1)
Time Frame: Post intervention: 3 months from baseline
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)
Time Frame: Follow-up: 6 months from baseline
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Working environment (T1)
Time Frame: Post intervention: 3 months from baseline
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.
Post intervention: 3 months from baseline
Working environment (T2)
Time Frame: Follow-up: 6 months from baseline
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.
Follow-up: 6 months from baseline
Perceived Stress (T2)
Time Frame: Follow-up: 6 months from baseline
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.
Follow-up: 6 months from baseline
Perceived Stress (T3)
Time Frame: Follow-up: 12 months from baseline
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.
Follow-up: 12 months from baseline
Cognitive functioning (T1)
Time Frame: Post intervention: 3 months from baseline
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.
Post intervention: 3 months from baseline
Work ability (T1)
Time Frame: Post intervention: 3 months from baseline
Self-report measure using the Work Ability Index (WAI), 1 item scale ranging from 0-10 with higher scores indicating better work ability
Post intervention: 3 months from baseline
Work ability (T2)
Time Frame: Follow-up: 6 months from baseline
Self-report measure using the Work Ability Index (WAI), 1 item scale ranging from 0-10 with higher scores indicating better work ability
Follow-up: 6 months from baseline
Work ability (T3)
Time Frame: Follow-up: 12 months from baseline
Self-report measure using the Work Ability Index (WAI), 1 item scale ranging from 0-10 with higher scores indicating better work ability
Follow-up: 12 months from baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Working environment (T3)
Time Frame: Follow-up: 12 months from baseline
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.
Follow-up: 12 months from baseline
Utilizations of psychotropic drug prescriptions
Time Frame: Participants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-up
Derived from the Danish national Register of Medical Products Statistics. Includes presciptions on antidepressants, anxiolytics, sedatives and anagesics.
Participants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-up
Sleep quality (T1)
Time Frame: Post intervention: 3 months from baseline
Self-report measure using the Basic Nordic Sleep Questionnaire (BSNQ), 7 items on a 1-5 scale, ranging from 7-35 points with higher scores indicating lower subjective sleep quality
Post intervention: 3 months from baseline
Sleep quality (T2)
Time Frame: Follow-up: 6 months from baseline
Self-report measure using the Basic Nordic Sleep Questionnaire (BSNQ), 7 items on a 1-5 scale, ranging from 7-35 points with higher scores indicating lower subjective sleep quality
Follow-up: 6 months from baseline
Sleep quality (T3)
Time Frame: Follow-up: 12 months from baseline
Self-report measure using the Basic Nordic Sleep Questionnaire (BSNQ), 7 items on a 1-5 scale, ranging from 7-35 points with higher scores indicating lower subjective sleep quality
Follow-up: 12 months from baseline
Symptoms of depression and anxiety (T1)
Time Frame: Post intervention: 3 months from baseline
Self-report measure using the Common Mental Disorders Questionniare (CMDQ), 10 items in total: 4 item on the anxiety scale (0-4 point scale, range 0-16) and 6 items on the depression scale (0-4 point scale, range 0-24) with higher scores indicating more severe symptoms.
Post intervention: 3 months from baseline
Symptoms of depression and axiety (T2)
Time Frame: Follow-up: 6 months from baseline
Self-report measure using the Common Mental Disorders Questionniare (CMDQ), 10 items in total: 4 item on the anxiety scale (0-4 point scale, range 0-16) and 6 items on the depression scale (0-4 point scale, range 0-24) with higher scores indicating more severe symptoms.
Follow-up: 6 months from baseline
Symptoms of depression and anxiety (T3)
Time Frame: Follow-up: 12 months from baseline
Self-report measure using the Common Mental Disorders Questionniare (CMDQ), 10 items in total: 4 item on the anxiety scale (0-4 point scale, range 0-16) and 6 items on the depression scale (0-4 point scale, range 0-24) with higher scores indicating more severe symptoms.
Follow-up: 12 months from baseline
Cognitive functioning (T2)
Time Frame: Follow-up: 6 months from baseline
Self-reportmeasure 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.
Follow-up: 6 months from baseline
Cognitive functioning (T3)
Time Frame: Follow-up: 12 months from baseline
Self-reportmeasure 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.
Follow-up: 12 months from baseline
Daily functioning (T1)
Time Frame: Post intervention: 3 months from baseline
Self-report measure using the Work and Social Adjustment Scale (WSAS), 5 items 0-8 point scale, ranging from 0-40 point, where higher scores indicate more impaired daily functioning.
Post intervention: 3 months from baseline
Daily functioning (T2)
Time Frame: Follow-up: 6 months from baseline
Self-report measure using the Work and Social Adjustment Scale (WSAS), 5 items 0-8 point scale, ranging from 0-40 point, where higher scores indicate more impaired daily functioning.
Follow-up: 6 months from baseline
Daily functioning (T3)
Time Frame: Follow-up: 12 months from baseline
Self-report measure using the Work and Social Adjustment Scale (WSAS), 5 items 0-8 point scale, ranging from 0-40 point, where higher scores indicate more impaired daily functioning.
Follow-up: 12 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lea Nørgaard Sørensen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gødstrup Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zara A Stokholm, MD, PhD, Department of Occupational and Environmental Medicine, Danish Ramazzini Centre, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-10-72-108-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings