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L'essai clinique NCT06799403 pour Stress lié au travail est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Stop for Stress - a Randomized Controlled Trial Comparing an Online and a Group-based Format of an Intervention for Work-related Stress
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L'étude clinique NCT06799403 est un essai interventionnel pour Stress lié au travail. Son statut actuel est : en recrutement. L'étude a débuté le 27 mars 2025 et vise à recruter 220 participants. Dirigé par Lea Nørgaard Sørensen, l'essai devrait être terminé d'ici le 1 août 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 17 juin 2025.
Résumé succinct
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.
Titre officiel
Stop for Stress - En Sammenligning af Online og Gruppebaseret Behandling for Arbejdsrelateret Stress
Conditions
Stress lié au travailPublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'essai
- 1-10-72-108-24
Numéro NCT
Date de début (réel)
2025-03-27
Dernière mise à jour publiée
2025-06-17
Date de fin (estimée)
2027-08
Inscription (estimée)
220
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
work-related stress
online intervention
group intervention
return-to-work
online intervention
group intervention
return-to-work
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalTherapist-assisted online delivery format 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. | 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. |
Comparateur actifGroup-based face-to-face delivery format 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 | 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 |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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. | Post intervention: 3 months from baseline |
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) | Follow-up: 6 months from baseline |
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 | Participants are followed continously from 5 yeras prior to enrollment (baseline) and until 12 months follow-up |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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. | Follow-up: 6 months from baseline |
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. | Follow-up: 12 months from baseline |
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. | Post intervention: 3 months from baseline |
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. | Post intervention: 3 months from baseline |
Working environment (T2) | 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. | Follow-up: 6 months from baseline |
Work ability (T1) | Self-report measure using the Work Ability Index (WAI), 1 item scale ranging from 0-10 with higher scores indicating better work ability | Post intervention: 3 months from baseline |
Work ability (T2) | Self-report measure using the Work Ability Index (WAI), 1 item scale ranging from 0-10 with higher scores indicating better work ability | Follow-up: 6 months from baseline |
Work ability (T3) | Self-report measure using the Work Ability Index (WAI), 1 item scale ranging from 0-10 with higher scores indicating better work ability | Follow-up: 12 months from baseline |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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
- 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
Lea Nørgaard SørensenGødstrup HospitalPartie responsable de l'essai
Lea Nørgaard Sørensen, Promoteur-Investigateur, PhD student, Aarhus University Hospital
Contact central de l'essai
Contact: Lea N Sørensen, MSc Psychology, +45 61369464, [email protected]
Contact: Zara A Stokholm, MD, PhD, +45 61369464, [email protected]
2 Centres de l'essai dans 1 pays
Central Region Denmark
Department of Occupational and Environmental Medicine, Aarhus University Hospital, Aarhus, Central Region Denmark, 8200, Denmark
Lea N Sørensen, MSc Psychology, Contact, +45 61369464, [email protected]
Zara A Stokholm, MD, PhD, Contact, +45 61369464, [email protected]
En recrutement
Department of Occupational and Environmental Medicine, Gødstrup Hospital, Herning, Central Region Denmark, 7400, Denmark
Marianne Kyndi, MD, PhD, Contact, +45 20949919, [email protected]
Pas encore en recrutement