Can talk therapy plus exercise beat arthritis fatigue?

NCT ID NCT06666452

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

39 people

The number who actually took part.

Started

Oct 2024

Finished

Mar 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Skåne University Hospital

    Lund, Sweden, Sweden

  • The Danish Hospital for Rheumatic Diseases

    Sønderborg, Denmark, 6400, Denmark

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