A 3-day Course for CFS/ME
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNorwegian University of Science and Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Underlying physical illness or mental disorder that may explain the symptoms.
Suicide risk/previous suicide attempts.
Pregnancy.
Bedridden and in need of continuous care.
Trial design
Design model
Parallel
Treatments tested in this trial
A 3-day course
BehavioralThe 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.
Waiting list
BehavioralTreatment 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: A 3-day courseExperimental treatment 1 intervention
Group B: Waiting listActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 weeks after the 3-day courseSecondary outcomes
1
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.
Time frame
6 months after the 3-day course2
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.
Time frame
6 months after the 3-day course3
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.
Time frame
6 months after the 3-day course4
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.
Time frame
6 months after the 3-day courseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Norwegian University of Science and Technology
Lead sponsor
University of Oslo
Collaborator
Haukeland University Hospital
Collaborator
Lørenskog municipality
Collaborator
The Research Council of Norway
Collaborator
Source ClinicalTrials.gov