Skip to content

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

PILOT STUDY: WEB-BASED TREATMENT OF SEVERE FATIGUE AMONG ADOLESCENT PATIENTS WITH AN IMMUNE DYSREGULATION DISORDER: A SINGLE-CASE EXPERIMENTAL DESIGN WITH MULTIPLE MEASUREMENTS. - Treatment of severely fatigued adolescents with an IDD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47565
Enrollment
11
Registered
2016-06-15
Start date
2016-08-22
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Participants will receive web-based CBT for fatigue in addition to usual care for their primary disease. The CBT treatment consists of 20 interactive treatment modules, over a period of six months.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Fatigue severity, measured with the fatigue severity scale of the CIS-20 questionnaire.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)