A 3-day Course for Adults With Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Physical function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The intervention group vs. waiting list control group status will be known to the participants and the personnel delivering the 3-day course. However, the investigator and outcome assessor will be masked to the conditions.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Physical function
时间窗: 10 weeks after the 3-day course
Measured through the Short Form Health Survey (SF-36), physical function, a scale that measures physical function with questions relating to ability to perform physical activity. The instrument contains 10 items with three options on each question. The score range is 0 -100, where 100 is equivalent to no disability.
次要结局
- Fatigue(6 months after the 3-day course)
- Overall improvement(6 months after the 3-day course)
- Sick leave(24 months after the 3-day course)
- Pain on a daily basis(6 months after the 3-day course)
- Post-Exertional Malaise(6 months after the 3-day course)
- Mental wellbeing(6 months after the 3-day course)