Pain in Pediatric Patients - Internet Interventions for Disorders of Gut-brain Interaction
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 17 years old?
Source: NCT07319078, who can take part
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- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- Karolinska Institutet
- Trial code
- NCT07319078
- Record updated
- 6 January 2026
- Original description
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.Read full original descriptionShow less
Internet-delivered Psychological Interventions for Pediatric Disorders of Gut-brain Interaction - a Randomised Controlled Study
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.
Inclusion: 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: 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.