Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06666452

COMFI - a COMbined Fatigue Intervention

Led by The Danish Center for Expertise in Rheumatology · Updated on 2025-08-15

40

Participants Needed

2

Research Sites

78 weeks

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

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.

CONDITIONS

Official Title

COMFI - a COMbined Fatigue Intervention

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Current fatigue level of 60 or above on the VAS-Fatigue 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 activity with no planned or recent (last 3 months) changes in pharmacological treatment including DMARDs or steroids
  • 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 without an interpreter
  • Interested in actively participating and making changes to daily life to improve their condition
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Serious illness with expected survival less than 2 years (e.g., cancer)
  • Heart failure with NYHA class 3 or 4
  • Kidney failure with eGFR below 30
  • Severe anemia with hemoglobin 5.0 mmol/L or less
  • Dysregulated diabetes with HbA1c above 53 mmol/mol
  • Dysregulated thyroid disease with TSH outside 0.4-4.0 mE/L
  • Unstable psychiatric illness
  • Dementia or severe cognitive problems
  • Hearing loss or use of hearing aids that affect group participation
  • Other physical or mental conditions preventing informed consent or group participation
  • Fatigue primarily caused by long-term effects after COVID-19 or chronic fatigue syndrome
  • Participation in other research projects affecting fatigue (WORK-ON, INSELMA, SPINCODE)
  • Participation in fatigue programs for hospitalized patients or related support
  • Planned rehabilitation stays or other fatigue programs elsewhere
  • Unable to commit to attending scheduled program dates

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

A

Astrid J Damgaard, PhD-student

CONTACT

J

Jette Primdahl, Professor

CONTACT

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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