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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-67
SponsorKarolinska Institutet

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

190 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Karolinska Institutet

Lead sponsor

Region Stockholm

Collaborator