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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06799403
Enrollment
220
Registered
2025-01-29
Start date
2025-03-27
Completion date
2027-08-31
Last updated
2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Work-Related Stress

Keywords

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

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.

Interventions

BEHAVIORALTherapist-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.

BEHAVIORALGroup-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

Sponsors

Gødstrup Hospital
CollaboratorOTHER
Lea Nørgaard Sørensen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Perceived stress (T1)Post intervention: 3 months from baselineSelf-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.
Obejctive cognitive functioning measures by ICAT (T2)Follow-up: 6 months from baselineICAT (Internet-Based Cognitive Assessment Tool) comprises 5 subtests (list learning, consonant repitition, letter-number sequencing, delayed list learning, visuomotor tracking)
Return-to-workParticipants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-upDerived from the Danish national DREAM registry, comprising information on weekly transfer income (e.g. long-term sickness absence) and employment status

Secondary

MeasureTime frameDescription
Working environment (T1)Post intervention: 3 months from baselinePerceived 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.
Working environment (T2)Follow-up: 6 months from baselinePerceived 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.
Perceived Stress (T2)Follow-up: 6 months from baselineSelf-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.
Work ability (T2)Follow-up: 6 months from baselineSelf-report measure using the Work Ability Index (WAI), 1 item scale ranging from 0-10 with higher scores indicating better work ability
Work ability (T3)Follow-up: 12 months from baselineSelf-report measure using the Work Ability Index (WAI), 1 item scale ranging from 0-10 with higher scores indicating better work ability
Work ability (T1)Post intervention: 3 months from baselineSelf-report measure using the Work Ability Index (WAI), 1 item scale ranging from 0-10 with higher scores indicating better work ability
Perceived Stress (T3)Follow-up: 12 months from baselineSelf-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.
Cognitive functioning (T1)Post intervention: 3 months from baselineSelf-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.

Other

MeasureTime frameDescription
Sleep quality (T2)Follow-up: 6 months from baselineSelf-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
Utilizations of psychotropic drug prescriptionsParticipants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-upDerived from the Danish national Register of Medical Products Statistics. Includes presciptions on antidepressants, anxiolytics, sedatives and anagesics.
Sleep quality (T3)Follow-up: 12 months from baselineSelf-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
Working environment (T3)Follow-up: 12 months from baselinePerceived 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.
Cognitive functioning (T2)Follow-up: 6 months from baselineSelf-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.
Symptoms of depression and anxiety (T1)Post intervention: 3 months from baselineSelf-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.
Symptoms of depression and axiety (T2)Follow-up: 6 months from baselineSelf-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.
Symptoms of depression and anxiety (T3)Follow-up: 12 months from baselineSelf-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.
Daily functioning (T3)Follow-up: 12 months from baselineSelf-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.
Daily functioning (T2)Follow-up: 6 months from baselineSelf-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.
Daily functioning (T1)Post intervention: 3 months from baselineSelf-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.
Cognitive functioning (T3)Follow-up: 12 months from baselineSelf-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.
Sleep quality (T1)Post intervention: 3 months from baselineSelf-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

Countries

Denmark

Contacts

Primary ContactLea N Sørensen, MSc Psychology
leanso@rm.dk+45 61369464
Backup ContactZara A Stokholm, MD, PhD
zarastok@rm.dk+45 61369464

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026