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

Lea Nørgaard Sørensen

Status: Enrolling

Conditions: Work-Related Stress

Treatments: Behavioral: Therapist-assisted online stress management; Behavioral: Group-based face-to-face stress management

Study type: Interventional

Funder types: Other

Identifiers

NCT06799403

1-10-72-108-24

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

Therapist-assisted online delivery format

Experimental group

Description:

Participants will 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.

Treatment:

Behavioral: Therapist-assisted online stress management

Group-based face-to-face delivery format

Active Comparator group

Description:

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:

Behavioral: Group-based face-to-face stress management