Understanding and treating fatigue in primary care patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.