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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

For all subjects:
• Age of 12-29 years old
• Able to speak, read, understand and write Dutch

Inclusion criteria for QFS-patients:
• Diagnosed with QFS according to the Dutch Guidelines
• Fatigue lasting for at least 6 months
• Debilitating fatigue which started before the age of 18, 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:
• CFS/ME diagnosis according to the CDC criteria before the age of 18
• No diagnosis of QFS
• Fatigue severity subscale (CIS8) score >39

Inclusion criteria for JIA:
• 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 before the age of 18
• CIS8 score >34 (mean + 1 SD)
• Being fatigued for at least 3 months

Siblings/friends (healthy individuals):
• Not severely fatigued (CIS8 < 40)
• The status of C. Burnetii serology will be assessed after inclusion

Exclusion Criteria

• Diagnosis of chronic Q-fever ánd 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)
• No smartphone

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Objective 1: Biological parameters (e.g. immunological profile, HPA axis,<br /><br>mitochondrial dysfunctioning, gut microbiome)<br /><br><br /><br>Objective 2: Fatigue severity based on the weekly outcome measurements on the<br /><br>smartphone is the primary outcome.<br /><br><br /><br>Objective 3: Fatigue severity based on the weekly outcome measurements on the<br /><br>smartphone.<br /><br><br /><br>Objective 4: Fatigue and all (personalized) fatigue associated factors assessed<br /><br>in the personalized EMA questionnaires.<br /><br><br /><br>Objective 5: Fatigue severity based on the weekly outcome measurements on the<br /><br>smartphone and change in the biological profile at interval T0, T2, T4. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Objective 1: none.<br /><br>Objective 2: quality of life and self-efficacy based on questionnaires at T0-T4.<br /><br>Objective 3: quality of life and self-efficacy based on VAS-items of weekly<br /><br>smartphone measurement.<br /><br>Objective 4: none.<br /><br>Objective 5: none.</p><br>