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

Официальное название

Stop for Stress - En Sammenligning af Online og Gruppebaseret Behandling for Arbejdsrelateret Stress

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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

Первичные конечные точки

• Perceived stress (T1) [Срок оценки: Post intervention: 3 months from baseline]
• Obejctive cognitive functioning measures by ICAT (T2) [Срок оценки: Follow-up: 6 months from baseline]
• Return-to-work [Срок оценки: Participants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-up]

Вторичные конечные точки (8)

• Perceived Stress (T2) [Срок оценки: Follow-up: 6 months from baseline]
• Perceived Stress (T3) [Срок оценки: Follow-up: 12 months from baseline]
• Cognitive functioning (T1) [Срок оценки: Post intervention: 3 months from baseline]
• Working environment (T1) [Срок оценки: Post intervention: 3 months from baseline]
• Working environment (T2) [Срок оценки: Follow-up: 6 months from baseline]
• Work ability (T1) [Срок оценки: Post intervention: 3 months from baseline]
• Work ability (T2) [Срок оценки: Follow-up: 6 months from baseline]
• Work ability (T3) [Срок оценки: Follow-up: 12 months from baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Дания · 2 центра

• Department of Occupational and Environmental Medicine, Aarhus University Hospital — Aarhus
• Department of Occupational and Environmental Medicine, Gødstrup Hospital — Herning

Публикации

• 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

Идентификаторы

NCT: NCT06799403 · 1-10-72-108-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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