Clinical trial NCT06799403: Stop for Stress - a Randomized Controlled Trial Comparing an Online and a Group-based Format of an Intervention for Work-related Stress
Official title: Stop for Stress - En Sammenligning af Online og Gruppebaseret Behandling for Arbejdsrelateret Stress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Work-Related Stress
Keywords: work-related stress
online intervention
group intervention
return-to-work
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Gødstrup Hospital
First posted: 2025-01-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Perceived stress (T1)
timeFrame: Post intervention: 3 months from baseline
measure: Obejctive cognitive functioning measures by ICAT (T2)
timeFrame: Follow-up: 6 months from baseline
measure: Return-to-work
timeFrame: Participants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-up
Secondary outcomes:
measure: Perceived Stress (T2)
timeFrame: Follow-up: 6 months from baseline
measure: Perceived Stress (T3)
timeFrame: Follow-up: 12 months from baseline
measure: Cognitive functioning (T1)
timeFrame: Post intervention: 3 months from baseline
measure: Working environment (T1)
timeFrame: Post intervention: 3 months from baseline
measure: Working environment (T2)
timeFrame: Follow-up: 6 months from baseline
measure: Work ability (T1)
timeFrame: Post intervention: 3 months from baseline
measure: Work ability (T2)
timeFrame: Follow-up: 6 months from baseline
measure: Work ability (T3)
timeFrame: Follow-up: 12 months from baseline
Other outcomes:
measure: Utilizations of psychotropic drug prescriptions
timeFrame: Participants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-up
measure: Working environment (T3)
timeFrame: Follow-up: 12 months from baseline
measure: Cognitive functioning (T2)
timeFrame: Follow-up: 6 months from baseline
measure: Symptoms of depression and anxiety (T1)
timeFrame: Post intervention: 3 months from baseline
measure: Symptoms of depression and axiety (T2)
timeFrame: Follow-up: 6 months from baseline
measure: Symptoms of depression and anxiety (T3)
timeFrame: Follow-up: 12 months from baseline
measure: Daily functioning (T3)
timeFrame: Follow-up: 12 months from baseline
measure: Daily functioning (T2)
timeFrame: Follow-up: 6 months from baseline
measure: Daily functioning (T1)
timeFrame: Post intervention: 3 months from baseline
measure: Cognitive functioning (T3)
timeFrame: Follow-up: 12 months from baseline
measure: Sleep quality (T1)
timeFrame: Post intervention: 3 months from baseline
measure: Sleep quality (T2)
timeFrame: Follow-up: 6 months from baseline
measure: Sleep quality (T3)
timeFrame: Follow-up: 12 months from baseline
Locations:
city: Aarhus
country: Denmark
facility: Department of Occupational and Environmental Medicine, Aarhus University Hospital
state: Central Region Denmark
city: Herning
country: Denmark
facility: Department of Occupational and Environmental Medicine, Gødstrup Hospital
state: Central Region Denmark
Study officials:
affiliation: Department of Occupational and Environmental Medicine, Danish Ramazzini Centre, Aarhus University Hospital
name: Zara A Stokholm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.