Actively Recruiting
Pain in Pediatric Patients - Internet Interventions for Disorders of Gut-brain Interaction
Led by Karolinska Institutet · Updated on 2026-01-06
200
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
R
Region Stockholm
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pain in Pediatric Patients - Internet Interventions for Disorders of Gut-brain Interaction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 8 and 17 years
- Completed basic somatic tests including CRP/ESR, TGA, complete blood count, and fecal calprotectin
- Confirmed diagnosis of DGBI: irritable bowel syndrome, functional abdominal pain, or functional dyspepsia per Rome IV criteria
- Constipation, if present, treated per guidelines with stable laxative dose for at least one month before referral
- For celiac disease, adherence to gluten-free diet for at least six months with normalized TGA values
- For neuropsychiatric diagnosis with medication, at least two months since last dose change
- At least one parent and the child/adolescent fluent in Swedish and willing to participate in education, treatment, homework, and questionnaires
You will not qualify if you...
- Presence of other organic diseases better explaining gastrointestinal symptoms
- Psychiatric symptoms or social problems at referral that are more severe than gastrointestinal issues and require extensive care beyond the study's scope
- Previous completion of gut-directed hypnotherapy or cognitive behavioral therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sachs Children's Hospital
Stockholm, Sweden, 17164
Actively Recruiting
Research Team
T
Tea Soini, MD PhD
CONTACT
F
Frida Andersson, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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