Clinical Trial

COMFI - a COMbined Fatigue Intervention

Study acronym: COMFI
Recruiting
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Record status
This record was last updated August 15, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
Background: Inflammatory arthritis (IA) encompasses autoimmune rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Fatigue is highly prevalent in people with IA with 41-57% suffering from severe fatigue. Patients describe fatigue as overwhelming, unpredictable, challenging to manage, and affecting all areas of everyday life, including the ability to work. Studies have shown that interventions with physical activity or a cognitive behavioral approach can significantly reduce fatigue severity and/or impact in people with IA compared to usual care. To date, no studies have investigated the combined effect of CBA and PA on fatigue severity and impact in patients with IA. Therefore, the goal of this study is to test the feasibility of a newly developed fatigue intervention that combines a cognitive behavioral approach and physical activity (COMFI) in patients with inflammatory arthritis, who experience fatigue as a challenge in their everyday lives in Denmark and Sweden. The intervention will be tested in 4 groups (2 in Denmark and 2 in Sweden), and the participants will participate in 7 group sessions and 2 focusgroups interview in the evaluation. The primary outcome for the participants is fatigue, measured through patient-reported outcomes at baseline, 3, 6, and 12 months after baseline. This study will show if the intervention is feasible in practice and meaningful for the participants.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-29.
Trial Details
NCT Number NCT06666452
Lead Sponsor The Danish Center for Expertise in Rheumatology
Collaborators: Skane University Hospital, Odense Patient Data Explorative Network, The Danish Rheumatism Association, Region of Southern Denmark, University of Southern Denmark, Bristol Royal Infirmary
Conditions Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Spondyloarthritis (SpA), Inflammatory Arthritis
Enrollment 40 participants
Start Date 2024-10-01
Primary Completion 2026-04 (estimated)
Study Completion 2026-04 (estimated)
Updated on ClinicalTrials.gov 2025-08-15