CompletedNot Applicable

Internet-delivered CBT for Irritable Bowel Syndrome in Adolescents

Sweden101 participantsStarted 2013-11

Plain-language summary

This randomized controlled trial aims to evaluate the treatment effects of an internet-delivered CBT-program for adolescents with irritable bowel syndrome.

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 13-17 at inclusion date. * fulfilling Rome III-criteria for IBS with a written statement from patient's physician confirming a diagnosis of IBS and negative required tests (Blood samples: C-reactive protein or erythrocyte sedimentation rate, Blood count and IgA-Transglutaminase. Stool: f-Calprotectin). Exclusion Criteria: * concurrent serious medical conditions. * a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain. * on-going psychological treatment. * absence from school exceeding an average of 2 days a week is a cause for exclusion since high absence demands more intensive interventions than can be offered in ICBT. * on-going abuse or severe parental psychiatric illness in the family. * since treatment format assumes normal reading and writing skills, pronounced language skill deficits and learning difficulties lead to exclusion from the study. * lack of regular internet-access.

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

Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).

Timeframe: Baseline to 10 weeks.

Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).

Timeframe: Baseline to 9 months.

Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).

Timeframe: Baseline to 15 months.

Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).

Timeframe: Baseline to 27 months.

Trial details

NCT IDNCT02306369

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

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.

What they're measuring

Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).

Timeframe: Baseline to 10 weeks.

Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).

Timeframe: Baseline to 9 months.

Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).

Timeframe: Baseline to 15 months.

Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).

Timeframe: Baseline to 27 months.