Understanding and treating fatigue in primary care patients
Characterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care
This study is testing a new online therapy for fatigue to see if it helps people in primary care feel better compared to regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years to 67 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Stockholm, Gustavsberg) |
| Trial ID | NCT06786832 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance the understanding of fatigue as a symptom in primary care patients and to develop an accessible treatment targeting fatigue. It involves a randomized controlled trial with 500 participants to evaluate the effectiveness of a novel internet-delivered cognitive behavioral therapy (iFAS) compared to standard care. The primary outcome will measure changes in fatigue severity over a 6-month period, with long-term follow-up extending up to 60 months. The study will also investigate moderators and mechanisms of treatment effects to identify subgroups of fatigued individuals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-67 with severe, functionally disabling fatigue lasting at least 3 months, who are enrolled in a primary care clinic in Region Stockholm.
Not a fit: Patients with active disease processes or primary psychiatric disorders that require immediate evidence-based treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment for patients suffering from persistent fatigue, improving their quality of life.
How similar studies have performed: Other studies have shown promise in using cognitive behavioral therapy for fatigue, suggesting that this approach could be effective, although this specific application may be novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm, Gustavsberg
- Gustavsberg University Primary Care Clinic — Stockholm, Gustavsberg, Sweden (Recruiting)
Study contacts
- Principal investigator: Elin Lindsäter, PhD, Ass. Prof — Region Stockholm and Karolinska Institutet
- Study coordinator: Frank Svärdman, PhD-student
- Email: frank.svardman@ki.se
- Phone: +46 702308870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.