Characterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care

Launched by KAROLINSKA INSTITUTET · Jan 19, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding and treating fatigue in patients who visit primary care clinics. The study aims to test a new online therapy called iFAS (Internet-delivered treatment of Fatigue Across Syndromes) to see if it helps reduce fatigue compared to usual care. Researchers will recruit 500 participants aged 18 to 67 who have been experiencing severe fatigue for at least three months, but not due to an active illness or specific medication. Participants will need to have regular internet access and be able to read and write in Swedish, and they should be able to visit a study center for assessments and therapy sessions.

If you join the study, you can expect to either receive the new online therapy or continue with your usual care, and your fatigue levels will be measured before and after treatment, as well as at follow-up points up to five years later. The trial aims to identify different groups of people who may respond better to the treatment and also evaluate the overall cost-effectiveness of the new therapy. This research could lead to better support and treatment options for those struggling with fatigue in primary care settings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. age 18-67
• • 2. enrollment at a primary care clinic in Region Stockholm
• • 3. severe, functionally disabling fatigue as a central symptom for at least 3 months
• • 4. The fatigue has an identifiable start and hence has not been life-long;
• • 5. The fatigue is not a direct effect of an active disease process motivating another treatment (e.g., hypo-/hyperthyroidism, anemia, cancer, dementia) or the effect of medication
• • 6. regular access to a computer and to the Internet
• • 7. ability to read and write in Swedish.
• • 8. ability to visit a study center for participation in potential assessments and treatment sessions (maximum 60 minutes) and to take part of written material via the internet.
• Exclusion Criteria:
• • 1. substance abuse disorder in the past 6 months
• • 2. Current or past psychosis or bipolar disorder
• • 3. Primary psychiatric disorder of such severity that it merits evidence-based treatment (e.g., obsessive compulsive disorder, moderate to severe depression, post-traumatic stress disorder, anorexia nervosa)
• • 4. elevated risk for suicide
• • 5. deliberate self harm in the past 6-months (e.g., cutting, burning, poisoning);
• • 6. BMI\>40
• • 7. Initiated or changed psychopharmacological medication (e.g., for depression or anxiety disorders) in the past month
• • 8. ongoing chemotherapy
• • 9. intellectual disability (e.g., severe autism) that affects ability to work with the treatment
• • 10. pregnancy
• • 11. life circumstances that complicate or make treatment impossible (e.g., domestic violence, ongoing legal disputes, disputes with social insurance agency, planed or on-going work capacity assesment regarding permanent work disability pension or planed surgery)
• • 12. ongoing psychological treatment and/or multimodal rehabilitation.
• • 13. working night shifts