Can talk therapy plus exercise beat arthritis fatigue?
NCT ID NCT06666452
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests a new 24-week program called COMFI that combines a cognitive behavioral approach with physical activity to help people with inflammatory arthritis manage fatigue. Participants attend group sessions, an optional individual session, and a booster session, and they wear an activity monitor. The study measures fatigue through questionnaires at several points over a year. The goal is to see if the program is practical and meaningful for people living with fatigue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- COMFI, a 24-week group-based program combining cognitive behavioral approach and physical activity
- What this could lead to
- If it works, this could lead to a practical, non-drug program that helps people with inflammatory arthritis manage fatigue better in daily life.
- What could go wrong
- This is a small feasibility study, so it may not show clear benefits or may not work for everyone. The program requires time and effort, and results may not apply beyond the study groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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39 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Current fatigue level (VAS-Fatigue: The VAS-fatigue has to be 60 or above. 2. Must have experienced fatigue as a challenge for at least the last 3 months 3. A rheumatologist-confirmed diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Spondyloarthritis 4. 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. 5. Must be affiliated with the Danish Hospital of Rheumatic Diseases or Skaane University Hospital in Lund. 6. Age ≥18 years. 7. Must be able to speak and write Danish or Swedish well enough to participate in group discussions without an interpreter. 8. The participant must be interested in actively participating and making changes to daily life to improve their condition. Exclusion Criteria: 1. Pregnant or breastfeeding 2. 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 3. 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 4. 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 5. Conditions that may be the primary cause of fatigue: * Long-term effects after COVID-19 * Chronic fatigue syndrome 6. Participation in another research project that could affect fatigue (WORK-ON, INSELMA, SPINCODE) 7. Participation in the fatigue program for hospitalized patients or support in another way specifically related to fatigue 8. The participant must not have a planned rehabilitation stay (e.g., Danish Rheumatism Hospital, Sano, Montebello) or another program elsewhere that works with fatigue 9. If the participant cannot commit to attending on the scheduled dates in one of the two programs.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Skåne University Hospital
Lund, Sweden, Sweden
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The Danish Hospital for Rheumatic Diseases
Sønderborg, Denmark, 6400, Denmark
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