Pain in Pediatric Patients - Internet Interventions for Disorders of Gut-brain Interaction
PIPPI
Internet-delivered Psychological Interventions for Pediatric Disorders of Gut-brain Interaction - a Randomised Controlled Study
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2025
CompletedFirst Submitted
Initial submission to the registry
December 7, 2025
CompletedFirst Posted
Study publicly available on registry
January 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
January 6, 2026
December 1, 2025
4.2 years
December 7, 2025
December 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peds QL gastro
Description: Short questionnaire gastrointestinal symptom scale. Minimum value 0, maximum value 100, higher score means better outcome.
Assessments will be collected at baseline, after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6-month follow-up
Secondary Outcomes (8)
Pain frequency
Assessments will be collected at baseline, after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6- and 24- month follow-up.
Pain intensity
Assessments will be collected at baseline, after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6- and 24- month follow-up.
Stress
Assessments will be collected after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6-month follow-up
Gastrointestinal symtom -related anxiety
Assessments will be collected at baseline, after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6-month follow-up.
GI symptom specific anxiety
Assessments will be collected after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6-month follow-up
- +3 more secondary outcomes
Other Outcomes (1)
Utilisation of health-care resources
The TIC-P will be administered at baseline, post-intervention, and at 6- and 24-month follow-up for both treatment arms (hypnotherapy and internet-based CBT).
Study Arms (2)
Gut-directed hypnotherapy via audiofiles
EXPERIMENTAL12-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.
Internet-delivered cognitive behavioral therapy
EXPERIMENTALThe participants receive access to a 10-week cognitive behavioral therapy (CBT) -programme.
Interventions
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.
The programme aims to alleviate gastrointestinal symptoms through deep relaxation and positive suggestions to alter the imagery related to the gut.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Region Stockholmcollaborator
Study Sites (1)
Sachs Children's Hospital
Stockholm, 17164, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ola Olén, Professor
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 7, 2025
First Posted
January 6, 2026
Study Start
December 1, 2025
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
March 1, 2030
Last Updated
January 6, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share