Stop for Stress - a Randomized Controlled Trial Comparing an Online and a Group-based Format of an Intervention for Work-related Stress
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Therapist-assisted online stress management, Group-based face-to-face stress management.
- Who it may be relevant to
- Registry conditions: Work-Related Stress. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Stop for Stress - En Sammenligning af Online og Gruppebaseret Behandling for Arbejdsrelateret Stress
Overview
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
- 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. - 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
Primary outcome measures
- Perceived stress (T1) [Time frame: Post intervention: 3 months from baseline]
- Obejctive cognitive functioning measures by ICAT (T2) [Time frame: Follow-up: 6 months from baseline]
- Return-to-work [Time frame: Participants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-up]
Secondary outcome measures (8)
- Perceived Stress (T2) [Time frame: Follow-up: 6 months from baseline]
- Perceived Stress (T3) [Time frame: Follow-up: 12 months from baseline]
- Cognitive functioning (T1) [Time frame: Post intervention: 3 months from baseline]
- Working environment (T1) [Time frame: Post intervention: 3 months from baseline]
- Working environment (T2) [Time frame: Follow-up: 6 months from baseline]
- Work ability (T1) [Time frame: Post intervention: 3 months from baseline]
- Work ability (T2) [Time frame: Follow-up: 6 months from baseline]
- Work ability (T3) [Time frame: Follow-up: 12 months from baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Denmark · 2 centers
- Department of Occupational and Environmental Medicine, Aarhus University Hospital — Aarhus
- Department of Occupational and Environmental Medicine, Gødstrup Hospital — Herning
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. PMID 21057736
Identifiers
NCT: NCT06799403 · 1-10-72-108-24