A 3-day Course for CFS/ME

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Fatigue Syndrome, Myalgic Encephalomyelitis

Intervention / Treatment
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* Behavioral: A 3-day course
* Behavioral: Waiting list


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or to the waiting list control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A 3-day course<br>The course consists of teaching in basic psychology, stress physiology and practice of a specific technique with self-instructions and visualization in a group setting by non-health personnel | Behavioral: A 3-day course<br>* 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.<br>|
| Active Comparator: Waiting list<br>Treatment as usual (TAU) | Behavioral: Waiting list<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function | 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. | 10 weeks after the 3-day course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Measured through the Chalder Fatigue Questionnaire, an instrument that measures fatigue severity, both on mental and physical fatigue in the last month. The instrument contains 11 items with four different response options in each question. The scale ranges from 0-33, where higher score indicates greater fatigue. | 6 months after the 3-day course | 
| Pain on a daily basis | Measured through the Brief Pain Inventory, an instrument measuring pain and its allied aspects. The instrument contains 11 items with numeric rating from 0-10, where higher score indicates more severe pain. | 6 months after the 3-day course | 
| Post-Exertional Malaise | Measured through A Brief Questionnaire to Assess Post-Exertional Malaise, an instrument that measures symptoms after activity. The instrument contains 10 items, with options ranging from 0-4, where a higher score indicates more severity. | 6 months after the 3-day course | 
| Mental wellbeing | Measured trough the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), an instrument that measures mental wellbeing. The instrument contains 14 items, with 5 response categories, summed to provide a single score. Higher score indicates better wellbeing. | 6 months after the 3-day course | 
| Overall improvement | Measured through the Patient Global Impression of Change (PGIC) with one single item that measures change in function, symptoms and quality of life. The instrument has seven possible options ranging from very much better to very much worse. | 6 months after the 3-day course | 
| Sick leave | Register data from the Norwegian Labour and Welfare Administration (NAV) on sick leave, benefits, diagnoses from 12 months before the 3-day course and 24 months after the 3-day course. | 24 months after the 3-day course | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health education, Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME), RCT, 3-day Course, Physical function, Fatigue, Cognitive techniques, Behavioral activation