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A 3-day Course for CFS/ME

Без фазы С лечением Chronic Fatigue Syndrome Myalgic Encephalomyelitis

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: A 3-day course, Waiting list.
Кому может быть актуально
Состояния в реестре: Chronic Fatigue Syndrome, Myalgic Encephalomyelitis. Базовые параметры: 18 лет — 65 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
Норвегия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A 3-day Course for Adults With Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): a Randomized Controlled Trial

Обзор

Chronic fatigue syndrome/Myalgic encephalomyelitis (CFS/ME) can be a serious and disabling condition with a heavy symptom burden and low function. Work disability is common, and social life dramatically affected. CFS/ME is a challenging health problem as well as a societal problem. In recent years, a doubling of the number of patients with a CFS/ME diagnoses has been reported in Norway. The patient group represents a challenge for the health care system, the municipality, and the Norwegian Labour and Welfare Organization (NAV). According to new figures, the NAV pays 100 million Norwegian Kroner (NOK) each month in permanently incapacitated expenses for people with CFS/ME. Municipalities have expenses in form of care, rehabilitation and other measures. There is a lack of effective treatment for CFS/ME. Evidence-based knowledge is highly needed. If the 3-day course shows promising effects, this could have positive consequences for patients, relatives and health personnel, but also financially for the society and the municipality.

Подробное описание

This is a randomized controlled trial (RCT) to investigate potential effects (positive and negative) of a 3-day course with follow-up for 100 adults with CFS/ME.

The 3-day course used in this trial is named the Lightning Process (LP). The course is built on the LP manual (Parker, 2013) and includes stress theory, Positive Psychology and knowledge about regulating thoughts, feelings and behavior, and through that positively influencing physiology.

Positive and negative effects of the course on symptoms, disability and quality of life will be investigated, and a long-term follow-up of work participation conducted.

Any adverse events experienced during or after the 3-day course will be handled according to protocol.

Вмешательства

  • Поведенческое A 3-day course
    The course is built on the LP manual (Parker, 2013) and includes stress theory, Positive Psychology and knowledge about regulating thoughts, feelings and behavior, and through that positively influencing physiology.
  • Поведенческое Waiting list
    Treatment as usual (TAU) in the first 10 weeks. After 10 weeks: Behavioural: A 3-day course. The course is built on the LP manual (Parker, 2013) and includes stress theory, Positive Psychology and knowledge about regulating thoughts, feelings and behavior, and through that positively influencing physiology.

Первичные конечные точки

  • Physical function [Срок оценки: 10 weeks after the 3-day course]
Вторичные конечные точки (6)
  • Fatigue [Срок оценки: 6 months after the 3-day course]
  • Pain on a daily basis [Срок оценки: 6 months after the 3-day course]
  • Post-Exertional Malaise [Срок оценки: 6 months after the 3-day course]
  • Mental wellbeing [Срок оценки: 6 months after the 3-day course]
  • Overall improvement [Срок оценки: 6 months after the 3-day course]
  • Sick leave [Срок оценки: 24 months after the 3-day course]

Критерии участия

Критерии включения

  • CFS/ME diagnosis based on the Canada Consensus Criteria.
  • At least 50% out of school/work.
  • Readiness to change (corresponding to the preparation phase in transtheoretical model)
  • Has given informed consent.

Критерии исключения

  • Assessed by a General Practitioner (GP):
  • Underlying physical illness or mental disorder that may explain the symptoms.
  • Suicide risk/previous suicide attempts.
  • Pregnancy.
  • Bedridden and in need of continuous care.
  • Insufficient Norwegian speaking or writing skills to participate in the 3-day course and fill out questionnaires.

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

Норвегия · 1 центр
  • Department of Psychology, NTNU — Trondheim

Идентификаторы

NCT: NCT05236465 · 394844

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗