Characterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care (NCT06786832) | Clinical Trial Compass
RecruitingNot Applicable
Characterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care
Sweden190 participantsStarted 2025-02-06
Plain-language 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.
Who can participate
Age range18 Years – 67 Years
SexALL
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Inclusion criteria
✓. age 18-67
✓. enrollment at a primary care clinic in Region Stockholm
✓. severe, functionally disabling fatigue as a central symptom for at least 3 months
✓. The fatigue has an identifiable start and hence has not been life-long;
✓. 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
✓. regular access to a computer and to the Internet
✓. ability to read and write in Swedish.
✓. 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
✕. substance abuse disorder in the past 6 months
✕
What they're measuring
1
Self-rated fatigue severity
Timeframe: Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline))
✕. 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)
✕. elevated risk for suicide
✕. deliberate self harm in the past 6-months (e.g., cutting, burning, poisoning);
✕. BMI\>40
✕. Initiated or changed psychopharmacological medication (e.g., for depression or anxiety disorders) in the past month