A study focused at identifying disrupted biological factors and patient-tailored interventions for adolescents with Q-Fever Fatigue Syndrome

• Conditions: Q-fever fatigue syndrome (QFS), Juvenile Idiopathic Arthritis (JIA) and Chronic Fatigue Syndrome (CFS/ME).

• Registration Number: NL-OMON24476
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

All subjects must meet the following criteria:
• Age of 12-25 years old
• Able to speak, read, understand and write Dutch

Inclusion criteria for QFS-patients:
• (Suspected) diagnosis with QFS according to the Dutch Guidelines.
• Fatigue lasting for at least 6 months.
• Debilitating fatigue, with detrimental effects on daily functioning (work and/or private situation).
• Seropositive for C. Burnetii.
• No diagnoses of chronic Q-fever, recent diagnostics (<3 months ago) showing a IgG fase 1 titer <1:1024 (or 1:512 in the case of immunocompromised patients or patients with vascular prosthesis or heart defect).
• No somatic of psychiatric comorbidity that can explain fatigue at baseline.
• No history of fatigue before infection with C. Burnetii, or fatigue critically increased in severity after infection with C. Burnetii.
• For CBT: Fatigue severity subscale (CIS8) score>39

Inclusion criteria for CFS/ME patients:
• (Suspected) CFS/ME diagnosis according to the CDC criteria.
• No diagnosis of QFS.
• Fatigue severity subscale (CIS8) score >39.

Inclusion criteria for JIA patients:
• Diagnosed with JIA, at least 3 months on stable medication and a stable disease activity score (JADAS-criteria).
• No diagnosis of QFS.
• Expressing fatigue as a major complaint and CIS8 score >34 (mean +1SD).
• Being fatigued for at least 3 months.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Diagnosis of chronic Q-fever and active disease.
• Cognitive impairment, estimated IQ<70.
• Concomitant diagnoses that may explain the fatigue.
• Any current and predominated psychiatric comorbidity with could explain fatigue (i.e. major depression disorder, presence of suicidal risk).
• Owns no smartphone.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue severity

Secondary Outcome Measures

Name	Time	Method
Self-efficacy and quality of life