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Clinical Trials in Denmark / NCT05486585
Active, not recruiting Not applicable

i-CBT Functional Gastrointestinal Disorders in Youth: the Impact of Negative Illness Understanding and Parental Illness Worries

NCT05486585 · tracked via the Priya Life Science Denmark tracker
Sponsor
Aarhus University Hospital
Phase
Not applicable
Started
2022-11-17
Last updated
2025-05-11

Condition(s) studied

Functional Abdominal Pain SyndromeFunctional Gastrointestinal DisordersIrritable Bowel Syndrome

Investigational drug(s) / intervention(s)

Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders

Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders: The offered treatment will be the Danish versions of the Swedish i-CBT programs for children. The child i-CBT program consists of 10 modules for the child and 10 for parents. The adolescent i-CBT program consists of 10 modules for the adolescent and 5 modules for the parents. Child and adolescents modules compose of exposure exercises for symptoms, behavioural analyses and affect labelling and are adjusted for the specific age group. Parent modules aim at supporting parents in helping their child to engage in the challenging exposure exercises. The family needs to select one parent to participate in the parent program. The participants will be expected to use approximately 4 hours per week. The programs will be delivered over ten weeks, and therapist support will be provided on a weekly basis.

Study summary

The aim of the current study, embedded in The Danish FGID Treatment Study, is to test Danish versions of Swedish i-CBT programs for children and adolescents with FGID in a Danish clinical context and to further evaluate the presence and impact of important psychological and parental factors.

Eligibility

Sex
ALL
Min age
8 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Child age: 8-12 years, adolescents: 13 - 17 years * A primary diagnosis according to the ROME-IV criteria of one of the FGID sub-types: Irritable bowel syndrome (IBS) or functional abdominal pain not-otherwise-specified (FAP-NOS) * The diagnosis should be documented by their regular physician in the somatic setting, and recommended routine medical investigations should be evaluated as normal or without clinical significance (include growth; blood samples including TSH, total IgA, IgA tissue transglutaminase, complete blood count, C-reactive protein analysis, liver enzymes; and fecal calprotectin) * Stable dosage of FGID-related medication such as laxatives, anti-diarrheal medication or pain-modulating psychopharmacological medication during the past month. Exclusion Criteria: * Another disease that explains the symptoms; * Severe psychiatric or social problems (e.g., high level of suicidal ideation or ongoing abuse); * Ongoing psychological treatment; * Insufficient language or computer skills (patients and parents); * Severe family problems (e.g. child abuse, parental substance abuse or severe psychiatric illness, ongoing custody fight) * School absence of more than 40% over the past month.

Primary outcome measure(s)

  • Change in gastrointestinal symptoms assessed by PedsQL Gastro Symptom Scales — At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]
    The self-report questionnaire revised version of PedsQL Gastro Symptom Scales, with 9 items. Answered on a 5 point scale from 0 ("never") to 4 ("almost always)
  • Change in gastrointestinal symptoms rated by parents assessed by PedsQL Gastro Symptom Scales — At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]
    The parent-report questionnaire revised version of PedsQL Gastro Symptom Scales, with 9 items. Answered on a 5 point scale from 0 ("never") to 4 ("almost always)

Trial sites (1)

FacilityCityRegionStatus
Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry Aarhus Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05486585 on ClinicalTrials.gov ↗ ← All trials in Denmark