Actively Recruiting
The Feasibility Test of a Combined Fatigue Intervention (COMFI) for People With Inflammatory Arthritis
Led by The Danish Center for Expertise in Rheumatology · Updated on 2025-08-15
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Danish Center for Expertise in Rheumatology
Lead Sponsor
S
Skaane University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new combined fatigue intervention (COMFI) for people with inflammatory arthritis (IA), including rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Fatigue is a common and severe problem in IA patients, affecting their quality of life and ability to work. This study aims to test if combining a cognitive behavioral approach and physical activity can reduce fatigue severity and impact in patients from Denmark and Sweden. The COMFI intervention is a 24-week outpatient program consisting of six group sessions based on cognitive behavioral approaches covering topics such as fatigue, physical activity, energy management, and peer support. A seventh booster group session is held at week 24, along with an optional individual session between weeks 6 and 9, and a support line available from weeks 13 to 23. Participants join groups of 8-10 people, with the intervention tested in four groups across two sites. Participants will complete patient-reported fatigue outcome measures at baseline, 3, 6, and 12 months, using questionnaires and databases. Physical activity and fitness will be measured at baseline and 6 months. Attendance and time use will be recorded by health professionals. The study also includes two focus group interviews for qualitative evaluation. Data confidentiality and ethical standards are maintained throughout the study, which will provide insights into the feasibility and meaningfulness of the intervention for IA patients.
CONDITIONS
Brief Title
COMFI - a COMbined Fatigue Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current fatigue level of 60 or above on a visual analog scale
- Fatigue has been a challenge for at least the last 3 months
- Rheumatologist-confirmed diagnosis of rheumatoid arthritis, psoriatic arthritis, or spondyloarthritis
- Stable disease phase with no planned or recent changes in pharmacological treatment in last 3 months
- Affiliated with the Danish Hospital of Rheumatic Diseases or Skaane University Hospital in Lund
- Age 18 years or older
- Able to speak and write Danish or Swedish well enough to participate in group discussions
- Interested in actively participating and making changes to improve their condition
You will not qualify if you...
- Pregnant or breastfeeding
- Serious illnesses with expected survival under 2 years, including cancer
- Heart failure classified as NYHA class 3 or 4
- Kidney failure with estimated glomerular filtration rate below 30
- Severe anemia with hemoglobin 5.0 mmol/L or less
- Poorly controlled diabetes (HbA1c over 53 mmol/mol)
- Poorly controlled thyroid disease (TSH outside 0.4-4.0 mE/L)
- Unstable psychiatric illness
- Dementia or severe cognitive problems
- Hearing loss or use of hearing aids affecting group participation
- Other physical or mental conditions affecting consent or participation
- Conditions causing fatigue such as long-term effects after COVID-19 or chronic fatigue syndrome
- Participation in other research affecting fatigue
- Participation in fatigue programs for hospitalized patients or other specific fatigue support
- Planned rehabilitation stays or other programs working with fatigue
- Inability to commit to attending scheduled program dates
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 24 weeks
Participants take part in the COMFI intervention, a 24-week group-based outpatient fatigue program combining a cognitive behavioral approach and physical activity support to help manage fatigue.
6 group sessions, 1 optional individual session between weeks 6-9, 1 booster group session at week 24, and a support line available during weeks 13-23
Duration - Up to 28 weeks after intervention (week 24 to week 52)
Participants complete follow-up assessments to evaluate fatigue and related outcomes after the intervention ends.
Assessments at week 52 via questionnaires and physical measurements
Trial Site Locations
Total: 2 locations
1
The Danish Hospital for Rheumatic Diseases
Sønderborg, Denmark, Denmark, 6400
Completed
2
Skåne University Hospital
Lund, Sweden, Sweden
Actively Recruiting
Research Team
A
Astrid J Damgaard, PhD-student
J
Jette Primdahl, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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