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.
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
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
Parallel
Gut-directed hypnotherapy
BehavioralThe programme aims to alleviate gastrointestinal symptoms through deep relaxation and positive suggestions to alter the imagery related to the gut.
Cognitive-behavioral therapy
BehavioralThe programme is therapist-led and delivered via the internet. It includes exposure-based exercises that aim to improve gastrointestinal symptoms by decreasing avoidance behavior.
Peds QL gastro
Description: Short questionnaire gastrointestinal symptom scale. Minimum value 0, maximum value 100, higher score means better outcome.
Pain frequency
Assessed by asking participants how many minutes or hours they have experienced abdominal pain during each day of the same 7-day period. This will give an estimate of the overall duration of pain episodes in addition to their intensity.
Pain intensity
Assessed with the Wong-Baker FACES Pain Rating Scale, a validated tool for children. At each measurement point, participants will rate their pain once daily for seven consecutive days, providing a weekly average of pain intensity.
Stress
PAS pediatric stress questionnare. Minimum value 0, maximum value 44, higher score means worse outcome
Gastrointestinal symtom -related anxiety
BRQ-C questionnare. Minimum value 11, maximum value 77, higher score means worse outcome.
Utilisation of health-care resources
Resource use will be assessed using the Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P), which measures direct medical, non-medical, and productivity-related costs over the preceding four weeks. A comprehensive health economic evaluation will be conducted, adopting a societal perspective to capture all relevant costs and consequences.
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Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
