Internet-delivered CBT for Irritable Bowel Syndrome in Adolescents

Karolinska Institute

Status: Completed

Conditions: Irritable Bowel Syndrome; Functional Gastrointestinal Disorders

Treatments: Behavioral: Internetdelivered exposure-based CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT02306369

ibs 13-17 år 2013

Details and patient eligibility

About

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

Full description

Irritable bowel syndrome (IBS) is prevalent and associated with low quality of life in adolescents. Medical or dietary treatments lack evident efficiency, while psychosocial interventions, i.e. cognitive behavior therapy (CBT)has shown promising effects in face-to-face treatments. Therapists trained to deliver CBT for IBS are scarce, leading to a situation where very few adolescents with IBS receive the only evidence-based intervention. Exposure-based internet-delivered CBT (ICBT) for adults with IBS has shown strong stable effects and cost-efficency. Our aim is to develop a treatment that enhances the availability to evidence-based treatment for children and adolescents with IBS. Such a treatment could swiftly be implemented in regular health care for this large population. The main purpose of this study is to compare the effectiveness of exposure-based ICBT to treatment as usual (wait-list) for adolescents with IBS.

Enrollment: 101 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Treatment as usual

No Intervention group

Description:

A wait-list control.

Internetdelivered exposure-based CBT

Experimental group

Description:

10 sessions of ICBT during 10 weeks for the adolescents. 5 session of parent training during 10 weeks for parents. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists.

Treatment:

Behavioral: Internetdelivered exposure-based CBT