Active — Not RecruitingNot Applicable

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

Denmark60 participantsStarted 2022-11-17

Plain-language 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.

Who can participate

Age range

8 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in gastrointestinal symptoms assessed by PedsQL Gastro Symptom Scales

Timeframe: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]

Change in gastrointestinal symptoms rated by parents assessed by PedsQL Gastro Symptom Scales

Timeframe: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]

Trial details

NCT IDNCT05486585

SponsorAarhus University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06

View on ClinicalTrials.gov More Functional Abdominal Pain Syndrome trials