CompletedNot Applicable

Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study

Sweden29 participantsStarted 2012-03

Plain-language summary

This pilot-study aims to evaluate the treatment effects and feasibility of an internet-delivered CBT-program for adolescents with functional gastrointestinal disorders.

Who can participate

Age range

13 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: * age between 13 and 17 years old. * a diagnosis of a functional gastrointestinal disorder by treating physician, e.g. IBS, FD or FAP. * adolescent and one parent should have easy access to the Internet, some computer experience and good Swedish language skills. Exclusion Criteria: * concurrent serious medical conditions or gastrointestinal symptoms likely caused by an organic disorder. * psychiatric diagnosis more urgent to treat than the abdominal pain. * on-going psychological treatment. * absence from school more than 20%. * on-going maltreatment, violence or severe parental psychiatric illness in the family. * pronounced language and learning difficulties depending on whether the youth was expected to benefit from the treatment or not.

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 gastrointestinal symptoms from baseline to 8 weeks, and from baseline to 6 months after treatment.

Timeframe: Baseline to 8 weeks, baseline to 8 months.

Trial details

NCT IDNCT02033161

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-06

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials

Who can participate

Age range

13 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.