PILOT STUDY: WEB-BASED TREATMENT OF SEVERE FATIGUE AMONG ADOLESCENT PATIENTS WITH AN IMMUNE DYSREGULATION DISORDER: A SINGLE-CASE EXPERIMENTAL DESIGN WITH MULTIPLE MEASUREMENTS.

Completed

Conditions: Het betreft immuun-dysregulatiestoornissen zoals JIA, JDM, CVID, MCTD, SLE, Syndroom van Sjögren etc
Immune dysregulation disorders / (auto)immune diseases
10027665

Registration Number: NL-OMON47565

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 11

Inclusion Criteria

- Age of 11,5 - 18 years old
- Able to speak, read, and write Dutch
- Diagnosed with an immune dysregulation disorder (i.g. JIA, JDM, CVID, MCTD, SLE etc)
- Being severely fatigued for at least 3 months (CIS fatigue * 40)
- Physical functioning subscale (Child Health Questionnaire) score * 85 and/or school absence > 10%
- At least 3 months on stable medication (type and dosage)
- Diagnosed with unexplained fatigue by the general paediatrician

Exclusion Criteria

- Suspicion of active disease requiring adaptation of treatment (at the time of inclusion) or a possible visit to the paediatric rheumatologist (during treatment)
- Cognitive impairment, estimated IQ <70
- A somatic cause assessed by the general paediatrician or co-morbid psychiatric disorder based on questionnaires that can explain fatigue at baseline assessment before the start of CBT
- An anxiety score above 44 on the Spielberger State-Trait Anxiety Inventory for Children (STAIC)
- A depression score above 15 on the Children*s Depression Inventory (CDI)
- Presence of suicidal risk, as assessed by CDI and general paediatrician
- Receiving treatment for a psychiatric disorder at time of inclusion
- No availability of computer with internet access

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Fatigue severity, measured with the fatigue severity scale of the CIS-20<br /><br>questionnaire.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. School presence, expressed in attended hours / obliged hours * 100% last two<br /><br>weeks<br /><br>2. Physical functioning, measured with the physical functioning scale of the CHQ<br /><br>3. Pain, measured with the with the VAS scores for pain (with scores ranging<br /><br>from 0-100 mm)</p><br>