Internet-delivered gut-directed hypnotherapy versus iCBT for stomach pain in children and teens
Internet-delivered Psychological Interventions for Pediatric Disorders of Gut-brain Interaction - a Randomised Controlled Study
This trial will test whether online gut-directed hypnotherapy or internet-based cognitive behavioral therapy helps children and adolescents (8–17) with IBS, functional abdominal pain, or functional dyspepsia reduce stomach pain and improve daily life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT07319078 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal participants are Swedish-speaking children and adolescents aged 8–17 with a Rome IV diagnosis of IBS, functional abdominal pain (FAP‑NOS), or functional dyspepsia who have completed basic medical testing and have a parent willing to engage in the online program.
Not a fit: Patients whose pain is better explained by an organic disease, who cannot use Swedish-language online materials, who cannot commit to regular homework or parent involvement, or who have recent changes in psychiatric medication are unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, this could give families a widely accessible, home-based treatment that reduces abdominal symptoms, improves quality of life, and shortens waits for care.
How similar studies have performed: Prior international trials, particularly from the Netherlands, have shown promising short- and long-term results for gut-directed hypnotherapy and have found home-based audio interventions to be as effective as face-to-face treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stockholm
- Sachs Children's Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Tea Soini, MD PhD
- Email: tea.soini@ki.se
- Phone: +46 766457611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.