NCT06666452Completed
COMFI - a COMbined Fatigue Intervention
The Feasibility Test of a COMbined Fatigue Intervention (COMFI) for People With Inflammatory Athritis
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 15 Oct 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 2 Mar 2026
- Lead sponsor
- The Danish Center for Expertise in Rheumatology
- Diseases
- Psoriasis, Psoriatic arthritis, Rheumatoid arthritis
- NCT number
- NCT06666452
What you commit to
- Study type: Interventional
- Participants enrolled: 39
- From 1 Oct 2024 to the primary completion date, 2 Mar 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A medical condition that would make the proposed interventions unsuitable/impossible for group participation or hinder the ability to give informed consent:
- Unstable psychiatric illness
- Dementia or other severe cognitive problems
- Hearing loss/use of hearing aids (it must be clarified how the person feels about being in a group setting)
- Other physical or mental conditions with the above effect
- Conditions that may be the primary cause of fatigue:
- Long-term effects after COVID-19
- Chronic fatigue syndrome
Lab values
- Critical/serious illness:
- Diseases with an expected survival of \< 2 years (e.g., cancer)
- Heart failure with NYHA class 3 or 4
- Kidney failure with eGFR \< 30
- Severe anemia - hemoglobin ≤ 5.0 mmol/L
- Clarification of known diseases, which must be well-treated or in remission:
- Diabetes: HbA1c \>53 mmol/mol is excluded if dysregulated
- Thyroid disease: TSH: 0.4-4.0 mE/L. Excluded if dysregulated
Other
- Pregnant or breastfeeding
- Participation in another research project that could affect fatigue (WORK-ON, INSELMA, SPINCODE)
- Participation in the fatigue program for hospitalized patients or support in another way specifically related to fatigue
- The participant must not have a planned rehabilitation stay (e.g., Danish Rheumatism Hospital, Sano, Montebello) or another program elsewhere that works with fatigue
- If the participant cannot commit to attending on the scheduled dates in one of the two programs.
Who the study is looking for
- Current fatigue level (VAS-Fatigue: The VAS-fatigue has to be 60 or above.
- Must have experienced fatigue as a challenge for at least the last 3 months
- A rheumatologist-confirmed diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Spondyloarthritis
- The patient is in a stable phase regarding disease activity. This means no current plans to adjust pharmacological treatment, and no changes in treatment in the last 3 months (DMARDs or steroids) incl. steroid injections.
- Must be affiliated with the Danish Hospital of Rheumatic Diseases or Skaane University Hospital in Lund.
- Age ≥18 years.
- Must be able to speak and write Danish or Swedish well enough to participate in group discussions without an interpreter.
- The participant must be interested in actively participating and making changes to daily life to improve their condition.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Danish Hospital for Rheumatic Diseases Coordinator of this site? Confirm its status | Sønderborg | Denmark | Unknown status |
| Skåne University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.