CompletedNot Applicable

Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders

Sweden20 participantsStarted 2014-04

Plain-language summary

The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.

Who can participate

Age range

8 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 8-12 years * A diagnosis of a functional gastrointestinal disorder by a treating physician Exclusion Criteria: * Concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder. * Psychiatric disorder more urgent to treat than the abdominal pain. * On-going psychological treatment. * Absence from school more than 40 %. * Ongoing maltreatment, violence or severe parental psychiatric illness. * Pronounced language or learning difficulties that hinder the child to benefit from the treatment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks

Timeframe: Baseline and 10 weeks

Change in Faces Pain Rating Scale (FACES) from baseline to 8 months.

Timeframe: Baseline and 8 months.

Trial details

NCT IDNCT02113605

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-11

View on ClinicalTrials.gov More Functional Gastrointestinal Disorders (FGID) trials