A 3-day course for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
A 3-day Course for Adults With Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): a Randomized Controlled Trial
NA · Norwegian University of Science and Technology · NCT05236465
This study is testing if a 3-day program called the Lightning Process can help adults with Chronic Fatigue Syndrome feel better and improve their daily lives.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Norwegian University of Science and Technology (other) |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT05236465 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a 3-day course called the Lightning Process on adults diagnosed with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). The course incorporates elements of stress theory and Positive Psychology to help participants regulate their thoughts, feelings, and behaviors, potentially improving their symptoms and quality of life. The study will assess both positive and negative outcomes, including disability and work participation, with a follow-up to evaluate long-term effects. Adverse events will be monitored and managed according to established protocols.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with CFS/ME who are at least 50% out of school or work and are ready to engage in a change process.
Not a fit: Patients with underlying physical or mental disorders that explain their symptoms, those at risk of suicide, or those who are bedridden will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and functional capacity of patients with CFS/ME.
How similar studies have performed: While there is limited evidence on the effectiveness of the Lightning Process specifically, similar interventions focusing on psychological approaches have shown promise in managing CFS/ME symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Trondheim
- Department of Psychology, NTNU — Trondheim, Norway (RECRUITING)
Study contacts
- Principal investigator: Leif Edward Ottesen Kennair, PhD prof — NTNU, Department of Psychology
- Study coordinator: Leif Edward Ottesen Kennair, PhD prof
- Email: kennair@ntnu.no
- Phone: +47 90557004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Health education, Chronic Fatigue Syndrome/Myalgic Encephalopathy, RCT, 3-day Course, Physical function, Fatigue