Actively Recruiting
A 3-day Course for Adults With Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): a Randomized Controlled Trial
Led by Norwegian University of Science and Technology · Updated on 2025-11-26
100
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
N
Norwegian University of Science and Technology
Lead Sponsor
U
University of Oslo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the potential effects of a 3-day course called the Lightning Process (LP) for adults with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). CFS/ME is a serious condition causing heavy symptoms, low function, and significant impact on work and social life. The study aims to explore both positive and negative effects on symptoms, disability, quality of life, and long-term work participation, addressing a challenging health and societal problem in Norway. The study randomly assigns about 100 adults with CFS/ME to either participate in the 3-day LP course or receive treatment as usual initially. The LP course includes teaching on stress theory, Positive Psychology, and techniques to regulate thoughts, feelings, and behavior to influence physiology positively. Those initially on the waiting list receive the LP course after 10 weeks. Adverse events during or after the course are monitored and managed according to protocol. Participants will be followed up with assessments including physical function at 10 weeks after the course and fatigue, pain, post-exertional malaise, mental wellbeing, overall improvement at 6 months. Work participation and sick leave are tracked at 24 months. The study involves questionnaires and evaluations to measure these outcomes, aiming to provide evidence-based knowledge for better CFS/ME care. The study runs until December 2028.
CONDITIONS
Brief Title
A 3-day Course for CFS/ME
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CFS/ME based on the Canada Consensus Criteria
- At least 50% out of school or work
- Readiness to change corresponding to the preparation phase in the transtheoretical model
- Given informed consent
You will not qualify if you...
- Underlying physical illness or mental disorder that may explain symptoms, as assessed by a General Practitioner
- Suicide risk or previous suicide attempts
- Pregnancy
- Bedridden and needing continuous care
- Insufficient Norwegian speaking or writing skills to participate and complete questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants attend a 3-day course that includes teaching in basic psychology, stress physiology, and practice of a specific technique with self-instructions and visualization in a group setting.
3 consecutive days of group sessions
Duration - Up to 24 months after the course
Participants are followed up to assess physical function, fatigue, pain, post-exertional malaise, mental wellbeing, overall improvement, and sick leave after the course.
Assessments at 10 weeks, 6 months, and 24 months after the course
Trial Site Locations
Total: 1 location
1
Department of Psychology, NTNU
Trondheim, Norway
Actively Recruiting
Research Team
L
Leif Edward Ottesen Kennair, PhD prof
L
Live Landmark
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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