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Набор скоро начнётся NCT07079709

Returning to Work After Stress-Related Sick Leave: An Effectiveness Trial of Work-Focused Treatments in Primary Care

Без фазы С лечением Clinical Burnout Exhaustion Disorder Adjustment Disorder With Work Inhibition

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Workfocused CBT, Standard Care (in control arm).
Кому может быть актуально
Состояния в реестре: Clinical Burnout, Exhaustion Disorder, Adjustment Disorder With Work Inhibition. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to learn if work-focused cognitive behaviour (WCBT) works to treat patients on sick leave due to non-traumatic long-term stress-related disorders. The main questions it aims to answer are: * Is WCBT more effective in improving work ability compared to standard care? * Do participants in WCBT have less sick leave days than those in standard care? * Is WCBT more effective in improving health outcomes and function than standard care? * Is WCBT a more cost-effective treatment option than standard care? Researchers will compare WCBT to standad care to see if there are differences in effect. Participants will participate in: * WCBT * Standard care

Вмешательства

  • Поведенческое Workfocused CBT
    In WCBT, the central idea is that CBT techniques can be applied in a work context with the aim of achieving both usual treatment goals related to symptoms and RTW. To ensure positive effects at both symptomatic and functional levels, a work perspective must be fully integrated into the intervention to optimize the treatment effect which demands collaboration with the sick leave prescribing doctor and the patient's employer. The protocol is based on principles of increasing return-to-work self-ef
  • Другое Standard Care (in control arm)
    Standard Care is defined as care by the sick leave prescribing physician and the rehab coordinator. Other interventions such as psychological treatment, physiotherapy etc. may also be included in this arm.

Первичные конечные точки

  • Work Ability Index (WAI) including Work Ability Score (WAS) [Срок оценки: WAI: Baseline, 6 months, 1- and 2 year follow-up. WAS: every two weeks during the first six months.]
Вторичные конечные точки (12)
  • Sick leave [Срок оценки: The time horizon is two years prior to and five years after the date for inclusion in the study.]
  • Current work status and sick leave [Срок оценки: Baseline, every two weeks until 6 months, 1- and 2-year follow-up.]
  • Shirom-Melamed Burnout Questionnaire (SMBQ-6) [Срок оценки: Baseline, every two weeks during 6 months, 1- and 2-year follow-up.]
  • Insomnia Severy Index (ISI) [Срок оценки: Baseline, 6 months, 1- and 2 year follow-up.]
  • Checklist Individual Strength [Срок оценки: Baseline, 6 months, 1- and 2 year follow-up.]
  • Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline, 6 months, 1- and 2 year follow-up.]
  • Generalized Anxiety Disorder Assessment (GAD-7) [Срок оценки: Baseline, 6 months, 1- and 2 year follow-up.]
  • Short Form Survey (SF-12) [Срок оценки: Baseline, 6 months, 1- and 2 year follow-up.]
  • Return to work Self-efficacy Scale [Срок оценки: Baseline, 6 months, 1- and 2 year follow-up.]
  • Work Phobia Questionnaire - short version [Срок оценки: Baseline, every two weeks until 6 months, 1- and 2 year follow-up.]
  • Perceived Competence Scale [Срок оценки: Baseline, 6 months, 1- and 2 year follow-up.]
  • Psychological avoidance of stress - The psychological inflexibility in stress scale [Срок оценки: Baseline, every two weeks during 6 months, 1- and 2 year follow-up.]

Критерии участия

Критерии включения

  • be on sick leave at least 50%
  • be diagnosed with a primary diagnosis adjustment disorder (F43.2-F.43.9) including exhaustion disorder (F43.8A)
  • be of working age (18-60 years)
  • be able to understand verbal and written Swedish or English
  • give informed consent

Критерии исключения

  • other psychiatric conditions that require prioritization for immediate or simultaneous treatment: specifically, a current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or organic mental disorder; current high risk of suicide; or recent (within 3 months) history of substance use disorder)
  • other ongoing or recent (within 6 months) psychological treatment for stress-related disorders

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07079709 · 2025-01713-01 · 2023-01487

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗