Active — Not RecruitingNot Applicable

ICBT for Children With FAPDs - the Child's Pain Regulation

Sweden80 participantsStarted 2023-11-01

Plain-language summary

Functional abdominal pain disorders (FAPDs) in children are common (14%) and abdominal pain has increased rapidly in children during the last ten years in Sweden. Many children with FAPDs have low quality of life, missed school days, and about 30-40% suffer from psychiatric comorbidity. FAPDs are often sustained into adulthood and a large Swedish cohort study showed that abdominal pain during childhood is an independent strong predictor anxiety and depression later in life. Internet-cognitive behavioral therapy (Internet-CBT) can improve FAPD symptoms, but a significant number of children does not respond to the treatment. We will here determine the pain regulation in children with FAPDs, compared with healthy controls, and assess: What aspects of the child's pain regulation is related to improvement for children with FAPDs engaging in Internet-CBT? Does some aspects of the child's pain regulation change during treatment?

Who can participate

Age range

8 Years – 17 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: Children 8-17 years with FAPDs: Have been offered treatment at BUP Internetbehandling for FAPDs. Children 8-17 years without FAPDs: Not affected by recurrent (every week) or persistant pain during the last year. Exclusion Criteria: Contraindication for MR (metal implant or metal object in body, claustrophobia, pregnancy)

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

Pressure pain threshold on navel

Timeframe: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)

Unpleasantness of pressure pain threshold on navel

Timeframe: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)

Trial details

NCT IDNCT05945251

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Functional Abdominal Pain Syndrome trials

Plain-language summary

Who can participate

Age range

8 Years – 17 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.

What they're measuring

Pressure pain threshold on navel

Timeframe: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)

Unpleasantness of pressure pain threshold on navel

Timeframe: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)