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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorKarolinska Institutet

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Gut-directed hypnotherapy
  • Cognitive-behavioral therapy

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Karolinska Institutet

Lead sponsor

Region Stockholm

Collaborator