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

Not Applicable

Recruiting

• Conditions: Work-Related Stress

• Registration Number: NCT06799403
• Lead Sponsor: Lea Nørgaard Sørensen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Study First Posted: 2025-01-29
• Study Start: 2025-03-27
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-17
• Primary Completion: 2027-01
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Return-to-work	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
Perceived stress (T1)	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.
Obejctive cognitive functioning measures by ICAT (T2)	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)

Secondary Outcome Measures

Name	Time	Method
Perceived Stress (T2)	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.
Perceived Stress (T3)	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.
Cognitive functioning (T1)	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.
Working environment (T1)	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.
Working environment (T2)	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.
Work ability (T2)	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
Work ability (T3)	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
Work ability (T1)	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

Trial Locations

Locations (2)

Department of Occupational and Environmental Medicine, Aarhus University Hospital; 🇩🇰 Aarhus, Central Region Denmark, Denmark

Department of Occupational and Environmental Medicine, Gødstrup Hospital; 🇩🇰 Herning, Central Region Denmark, Denmark