About this trial
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
Qualifiers
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;
Disqualifiers
substance abuse disorder in the past 6 months
Current or past psychosis or bipolar disorder
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
Trial design
Treatments tested in this trial
- Cognitive behavioral therapy for persistent fatigue
- Care as usual
Treatment groups
Sponsors and collaborators
Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator