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

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: Recruiting
• Conditions: Work-Related Stress
• Intervention / Treatment: Behavioral: Therapist-assisted online stress management; Behavioral: Group-based face-to-face stress management

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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: Marianne Kyndi, MD, PhD; Phone Number: +45 20949919; Email: marianne.kyndi@rm.dk

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Post intervention: 3 months from baseline
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.	Follow-up: 6 months from baseline
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.	Follow-up: 6 months from baseline
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.	Follow-up: 12 months from baseline
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.	Post intervention: 3 months from baseline
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	Post intervention: 3 months from baseline
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	Follow-up: 6 months from baseline
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	Follow-up: 12 months from baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working environment (T3)	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	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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

• Sponsor: Lea Nørgaard Sørensen
• Collaborators: Gødstrup Hospital
• Investigators: Principal Investigator: Zara A Stokholm, MD, PhD, Department of Occupational and Environmental Medicine, Danish Ramazzini Centre, Aarhus University Hospital

Publications and helpful links

General 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.

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: online intervention; group intervention; work-related stress; return-to-work
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Occupational Stress
• Other Study ID 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