Pain in Pediatric Patients - Internet Interventions for Disorders of Gut-brain Interaction

Recruiting now · Not applicable

Conditions studied: Irritable Bowel Disease, Functional Abdominal Pain - Not Otherwise Specified (FAP-NOS), Functional Dyspepsia

In brief

Many children and adolescents often experience long-lasting stomach pain. In many cases, this is due to disorders of gut-brain interaction (DGBI), such as irritable bowel syndrome (IBS), functional abdominal pain, and functional dyspepsia. These conditions are caused by disrupted communication between the brain and the gut. They are linked to significant suffering, reduced quality of life, and higher school absenteeism. Psychological treatments such as cognitive behavioral therapy (CBT) have shown good effect, but waiting times within healthcare are often long. Therefore, there is a need for more accessible and cost-effective treatment alternatives. The goal of this clinical trial is to explore whether gut-directed hypnotherapy, already used successfully in the Netherlands, can be implemented as a new treatment option in Swedish healthcare. In addition, the study will compare gut-directed hypnotherapy with internet-based CBT (iCBT) to learn which digital treatment works best for children and adolescents with DGBI. Participants will: Be children or adolescents between 8 and 17 years old. First take part in a 4-week online education program called the "gut-school," which explains the stomach, the brain, and how symptoms can be managed. If symptoms remain after the gut-school, be randomly assigned to one of two digital treatments: iCBT (internet-based cognitive behavioral therapy). 10 week long. Gut-directed hypnotherapy, delivered as audio recordings to be used at home. 12 week long. Answer online survey questions before, during, and after treatment so researchers can follow their progress. These two treatments have never been directly compared. By comparing them, researchers hope to learn not only which treatment works best overall, but also which treatment is most suitable for different participants. The long-term aim is to make gut-directed hypnotherapy, already successful in the Netherlands, available as a treatment option in Sweden.

Key facts

Study ID: NCT07319078
Run by: Karolinska Institutet
People needed: 200
Starts: 2025-12-01
Expected to finish: 2030-03-01
Last updated by the study team: 2026-01-06

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Sachs Children's Hospital — Stockholm, Sweden (enrolling)

Full record on ClinicalTrials.gov

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