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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLea Nørgaard Sørensen

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Therapist-assisted online stress management

    Behavioral

    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.

  • Group-based face-to-face stress management

    Behavioral

    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

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Therapist-assisted online delivery formatExperimental treatment 1 intervention
Group B: Group-based face-to-face delivery formatActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Post intervention: 3 months from baseline
2

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)

Time frame
Follow-up: 6 months from baseline
3

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

Time frame
Participants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-up

Secondary outcomes

1

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.

Time frame
Follow-up: 6 months from baseline
2

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.

Time frame
Follow-up: 12 months from baseline
3

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.

Time frame
Post intervention: 3 months from baseline
4

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.

Time frame
Post intervention: 3 months from baseline

Other outcomes

1

Utilizations of psychotropic drug prescriptions

Derived from the Danish national Register of Medical Products Statistics. Includes presciptions on antidepressants, anxiolytics, sedatives and anagesics.

Time frame
Participants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-up
2

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.

Time frame
Follow-up: 12 months from baseline
3

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.

Time frame
Follow-up: 6 months from baseline
4

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.

Time frame
Post intervention: 3 months from baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lea Nørgaard Sørensen

Lead sponsor

Aarhus University Hospital

Sponsor institution

Gødstrup Hospital

Collaborator