About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Therapist-assisted online stress management
BehavioralParticipants 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.
Group-based face-to-face stress management
BehavioralThe 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
Treatment groups
Trial outcomes
Primary outcomes
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.
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)
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
Secondary outcomes
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.
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.
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.
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.
Other outcomes
Utilizations of psychotropic drug prescriptions
Derived from the Danish national Register of Medical Products Statistics. Includes presciptions on antidepressants, anxiolytics, sedatives and anagesics.
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.
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.
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.
Sponsors and contacts
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Lea Nørgaard Sørensen
Lead sponsor
Aarhus University Hospital
Sponsor institution
Gødstrup Hospital
Collaborator