Internet-delivered Psychological Interventions for Pediatric Disorders of Gut-brain Interaction - a Randomised Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Sachs Children's Hospital
RECRUITING
Stockholm
Contact Information
Primary
Tea Soini, MD PhD
tea.soini@ki.se
+46 766457611
Backup
Frida Andersson, MSc
forskningsprojekt-pippi@ki.se
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2030-03
Participants
Target number of participants: 200
Treatments
Experimental: Gut-directed hypnotherapy via audiofiles
12-week self-administered hypnotherapy programme. Participants gain access to five different hypnotherapy exercises via audio files and are instructed to listen to them at least once a day.
Experimental: Internet-delivered cognitive behavioral therapy
The participants receive access to a 10-week cognitive behavioral therapy (CBT) -programme.
Sponsors
Leads: Karolinska Institutet
Collaborators: Region Stockholm

This content was sourced from clinicaltrials.gov