NCT06786832 Characterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care

Eligibility & Interventions

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This trial targets 190 participants in total. It began in 2025-02-06 with a primary completion date of 2027-06.

Brief Summary

The overarching purpose of this project is to further the understanding of fatigue as a symptom in primary care patients, and to build evidence for a highly accessible treatment targeting fatigue that can be readily implemented in primary care clinics. Data will be collected within a randomized controlled superiority trial. The primary aim is to evaluate the effectiveness of a transdiagnostic cognitive behavioral therapy (tCBT) for fatigued patients as compared to care as usual (CAU). Primary outcome will be change in fatigue severity (as measured by the Checklist Individual Strengths, fatigue subscale) pre- to post-treatment (6 months), with long-term controlled follow-up after 12 months. A register-based follow-up will be conducted up to 60 months post baseline. Moderators and mechanisms of treatment effect will be investigated with the aim to identify potential subgroups of fatigued individuals across and within diagnostic categories that may respond differently to treatment. Lastly, a health economic evaluation of long-term treatment effects will be conducted, which incorporates much needed detailed mapping of care as usual for fatigued patients.

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

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