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

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.

Conditions

• Irritable Bowel Disease
• Functional Abdominal Pain - Not Otherwise Specified (FAP-NOS)
• Functional Dyspepsia

Interventions

BEHAVIORAL

Gut-directed hypnotherapy

The programme aims to alleviate gastrointestinal symptoms through deep relaxation and positive suggestions to alter the imagery related to the gut.

BEHAVIORAL

Cognitive-behavioral therapy

The programme is therapist-led and delivered via the internet. It includes exposure-based exercises that aim to improve gastrointestinal symptoms by decreasing avoidance behavior.

Sponsors & Collaborators

• Region Stockholm

  collaborator OTHER_GOV

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Ola Olén, Professor · Karolinska Institutet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2030-03-31

Completion

2030-03-31

Countries

• Sweden

Study Locations