Internet-delivered gut-directed hypnotherapy versus iCBT for stomach pain in children and teens

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares two digitally delivered psychological treatments — a gut-directed hypnotherapy program adapted from successful Dutch protocols and an internet-based cognitive behavioral therapy (iCBT) program — using a secure Swedish online platform. Participants and at least one parent complete educational modules, regular homework, and outcome questionnaires, with treatments delivered as home-based audio and web content. The research builds on a Swedish pilot and international evidence showing benefits of hypnotherapy for disorders of gut–brain interaction, and outcomes include symptom scales such as the PedsQL Gastro and measures of function and school attendance. Clinical eligibility requires confirmed DGBI diagnosis (Rome IV), basic medical work-up, language fluency in Swedish, and stable management of comorbid conditions prior to enrollment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 8-17 years
* Basic somatic work-up completed (CRP/ESR, TGA, complete blood count, fecal calprotectin)
* Confirmed DGBI diagnosis: IBS, functional abdominal pain, or functional dyspepsia (according to Rome IV criteria)
* Any constipation must be treated according to current clinical guidelines, with stable laxative dosing for at least one month prior to referral
* In cases of celiac disease, the participant must have followed a gluten-free diet for at least six months and TGA values must have normalized
* For participants with a neuropsychiatric diagnosis treated with medication, at least two months must have passed since the last dose adjustment
* At least one parent and the child/adolescent must be fluent in Swedish and willing to participate in both the educational program and treatment (regardless of randomization outcome), complete homework assignments, and respond to questionnaires

Exclusion Criteria:

* Other organic disease that better explains the gastrointestinal symptoms
* At referral assessment, psychiatric symptoms or psychosocial problems - such as severe bullying, high school absenteeism, or difficult family circumstances - are judged to be more prominent than the gastrointestinal problems and require more extensive, multiprofessional care than what the study can offer
* Participants who have already completed gut-directed hypnotherapy or CBT

Where it's running

• Sachs Children's Hospital
  Stockholm, Sweden Recruiting

Study contacts

• Study coordinator: Tea Soini, MD PhD
• Email: tea.soini@ki.se
• Phone: +46 766457611

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.