Treatment of severely fatigued adolescents with an immune dysregulation disorder

Pilot study: web-based treatment of severe fatigue among adolescent patients with an immune dysregulation disorder: a single-case experimental design with multiple measurements

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12612526

Enrollment

Registered

2017-04-11

Start date

2016-08-02

Completion date

Unknown

Last updated

2017-05-08

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

Conditions

Immune dysregulation disorder Haematological Disorders Immune dysregulation disorder

Interventions

All participants will be randomized to receive the web-based cognitive behaviour therapy intervention after 7, 8, 10, 11, 13 (3x), 16, 18 or 24 weeks of randomization (the participants are their own c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age of 11.5 - 18 years old 2. Able to speak, read, and write Dutch 3. Diagnosed with JIA, JDM or CVID 4. Being severely fatigued for at least 3 months (CIS fatigue = 40) 5. Physical functioning subscale (Child Health Questionnaire) score = 85 and/or school absence > 10% 6. At least 3 months before treatment on stable medication (type and dosage) 7. Diagnosed with unexplained fatigue by the general paediatrician

Exclusion criteria

Exclusion criteria: 1. Suspicion of active disease requiring adaptation of treatment (at the time of inclusion) or a possible visit to the paediatric rheumatologist (during treatment) 2. Cognitive impairment, estimated IQ <70 3. 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 4. An anxiety score above 44 on the Spielberger State-Trait Anxiety Inventory for Children (STAIC), (average score of Dutch healthy adolescents plus 2 SD) 5. A depression score above 15 on the Children’s Depression Inventory (CDI), (average score of Dutch healthy adolescents plus 2 SD) 6. Presence of suicidal risk, as assessed by CDI and general paediatrician 7. Receiving treatment for a psychiatric disorder at time of inclusion 8. No availability of computer with internet access

Design outcomes

Primary

Measure	Time frame
Fatigue severity is measured with the fatigue severity scale of the CIS-20 weekly from baseline assessment the end of follow up (four weeks).	—

Secondary

Measure	Time frame
1. School presence is expressed in attended hours / obliged hours * 100% last two weeks measured weekly from baseline assessment the end of follow up (four weeks) 2. Physical functioning is measured with the physical functioning scale of the CHQ weekly from baseline assessment the end of follow up (four weeks) 3. Pain is measured with the with the VAS scores for pain (with scores ranging from 0-100 mm) weekly from baseline assessment the end of follow up (four weeks)	—

Measure

Time frame

1. School presence is expressed in attended hours / obliged hours * 100% last two weeks measured weekly from baseline assessment the end of follow up (four weeks) 2. Physical functioning is measured with the physical functioning scale of the CHQ weekly from baseline assessment the end of follow up (four weeks) 3. Pain is measured with the with the VAS scores for pain (with scores ranging from 0-100 mm) weekly from baseline assessment the end of follow up (four weeks)

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026