Clinical Trial

A Longitudinal Study on Longstanding Complicated Fatigue

Active, Not Recruiting
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Summary
The purpose of the study is to investigate if there are common biopsychosocial vulnerability factors for developing and maintaining fatigue, regardless of the diagnosis. The investigators also believe that subgroups differ in terms of these factors. Participating patients with ME/CFS, burnout syndrome and post-covid fatigue complete a web form at inclusion and after 1, 2, 4, 6, 12, 18 and 24 months. There is no upper limit for the number of participants in the web survey. 150 participants are asked to submit blood samples at a local laboratory in connection with the questionnaires for analysis of inflammatory markers and one urine sample for analysis of nutritional markers. Two control groups are included, 150 patients with rheumatoid arthritis and 50 healthy individuals. The longitudinal design makes it possible to investigate how inflammatory markers, nutritional status, symptom burden, health related quality of life co-vary over time and how work ability and sick leave is affected.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-07-05; most recent amendment 2025-05-19.
Status change: Recruiting → Active, Not Recruiting 2025-05-19
Status change: Not Yet Recruiting → Recruiting 2021-11-08
Trial Details
NCT Number NCT04955587
Lead Sponsor Stockholm University
Collaborators: Karolinska University Hospital, Karolinska Institutet, Linkoeping University
Conditions Chronic Fatigue Syndrome, Burnout, Covid19
Enrollment 150 participants
Start Date 2021-08-24
Primary Completion 2026-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2025-05-22