A 3-day Course for CFS/ME
A 3-day Course for Adults With Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): a Randomized Controlled Trial
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2022
CompletedFirst Posted
Study publicly available on registry
February 11, 2022
CompletedStudy Start
First participant enrolled
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
November 26, 2025
November 1, 2025
4.8 years
February 4, 2022
November 25, 2025
Conditions
Keywords
Outcome Measures
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.
10 weeks after the 3-day course
Secondary Outcomes (6)
Fatigue
6 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
Overall improvement
6 months after the 3-day course
- +1 more secondary outcomes
Study Arms (2)
A 3-day course
EXPERIMENTALThe 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
Waiting list
ACTIVE COMPARATORTreatment as usual (TAU)
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- University of Oslocollaborator
- Haukeland University Hospitalcollaborator
- Lørenskog municipalitycollaborator
- The Research Council of Norwaycollaborator
Study Sites (1)
Department of Psychology, NTNU
Trondheim, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leif Edward Ottesen Kennair, PhD prof
NTNU, Department of Psychology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2022
First Posted
February 11, 2022
Study Start
March 21, 2022
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
November 26, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The study protocol and the intervention protocol will be publicly available upon study completion.
- Access Criteria
- Anonymized data involving self-report data will be shared upon reasonable request from other researchers for use in specific research projects on CFS/ME when the main analyses are completed and published.
The study protocol, along with the intervention protocol, will be published and publicly available. Registry data will not be shared as this is not allowed to share according to Norwegian law. However, Anonymized data can be shared with other researchers on reasonable request for use in specific research projects on CFS/ME after this study has been published. Due to privacy concerns, the complete data files will not be shared online.