Micro-choice-based Intervention for Multicausal Fatigue

Официальное название

Micro-choice-based Intervention for Multicausal Fatigue: Proof of Concept Study

Обзор

This proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.

Подробное описание

The intervention of this study includes a preparation phase, a four-day intensive group treatment, and a follow-up phase to support the integration of new behaviors into daily life. As no comparable program currently exists in Switzerland, this project addresses a significant gap in care. If found to be feasible, the intervention has the potential to improve quality of life, support reintegration into daily and professional activities, and reduce the risk of disability and long-term work incapacity, thereby also contributing to lower healthcare costs.

Вмешательства

• Поведенческое Micro-choice-based intervention
  The intervention consists of three phases: (1) a preparation phase including a preparatory webinar about the concept of micro-choices; active decision to participate; (2) a concentrated four-day group intervention based on the micro-choice model, delivered by an interdisciplinary team (psychosomatics, internal medicine, physiotherapy, occupational therapy); and (3) a follow-up phase over three weeks, during which participants are supported in integrating behavioral changes into everyday life thr

Первичные конечные точки

• Retention rate [Срок оценки: up to 6 month]

Вторичные конечные точки (10)

• Patient satisfaction [Срок оценки: up to 6 month]
• Fatigue [Срок оценки: up to 6 month]
• Somatic Symptom Severity [Срок оценки: up to 6 month]
• Somatic Distress [Срок оценки: up to 6 month]
• Depressive Symptoms [Срок оценки: up to 6 month]
• Anxiety Symptoms [Срок оценки: up to 6 month]
• Functional capacity [Срок оценки: up to 6 month]
• Change in Quality of life [Срок оценки: up to 6 month]
• Work ability [Срок оценки: up to 6 month]
• Work and Social Adjustment [Срок оценки: up to 6 months]

Критерии участия

Критерии включения

\- Experiencing persistent fatigue with a significant impact on daily functioning (Chalder Fatigue- Scale bimodal ≥ 4)

Критерии исключения

• Have insufficient proficiency in German to complete study-related questionnaires
• Lack the cognitive capacity to understand study procedures (e.g. due to dementia)
• Present with severe medical conditions that may interfere with participation (e.g., advanced organ failure, uncontrolled inflammatory or autoimmune diseases, or severe psychiatric disorders)
• Have active cancer or are currently undergoing cancer treatment
• Are deemed incompatible with group participation during the preparation phase, based on a team assessment. Reasons for exclusion based on group incompatibility include:

• Need for a level of individual therapeutic support that exceeds what can be provided in a group setting; b) Refusal to engage in group-based therapy; c) Personality traits that are considered incompatible with group dynamics; d) Failure to attend the mandatory preparatory webinar (no-show is considered a no-go); e) Other significant reasons as determined by the therapeutic team)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• University Hospital Basel — Basel

Идентификаторы

NCT: NCT07726082 · 2025-01861; th25meinlschmidt2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗