Internet-delivered CBT for Irritable Bowel Syndrome in Adolescents

NCT ID: NCT02306369

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2017-11-18

Brief Summary

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

Detailed 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.

Conditions

Irritable Bowel Syndrome; Functional Gastrointestinal Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment as usual

A wait-list control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Internetdelivered exposure-based CBT

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.

Group Type: EXPERIMENTAL

Internetdelivered exposure-based CBT

Intervention Type: BEHAVIORAL

The Internet-delivered exposure treatment is based on the well-established internet-delivered CBT-treatment for IBS in adults, and adapted for adolescents and their parents. The feasibility of the treatment were tested in a pilot study during 2012. Components in the treatment are exposure for symptoms and parent training. The purpose of the treatment is to reduce fearful and anxious responses to symptoms and lessen avoidance of symptoms in the adolescents, and to teach the parents how parental behavior can influence symptoms in children. Detailed behaviour analysis is made for each individual and instruction is given on how to gradually expose to symptoms to lessen fear for symptoms and widen the behavioral repertoire.

Interventions

Internetdelivered exposure-based CBT

The Internet-delivered exposure treatment is based on the well-established internet-delivered CBT-treatment for IBS in adults, and adapted for adolescents and their parents. The feasibility of the treatment were tested in a pilot study during 2012. Components in the treatment are exposure for symptoms and parent training. The purpose of the treatment is to reduce fearful and anxious responses to symptoms and lessen avoidance of symptoms in the adolescents, and to teach the parents how parental behavior can influence symptoms in children. Detailed behaviour analysis is made for each individual and instruction is given on how to gradually expose to symptoms to lessen fear for symptoms and widen the behavioral repertoire.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Brjann Ljotsson

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brjánn Ljótsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Departement of Clinical neuropsychology, Karolinska Institutet

Locations

Child and Adolescent Psychiatry (CAP) Research Center

Stockholm, County of Stockholm, Sweden

Countries

Sweden

References

Sampaio F, Bonnert M, Olen O, Hedman E, Lalouni M, Lenhard F, Ljotsson B, Ssegonja R, Serlachius E, Feldman I. Cost-effectiveness of internet-delivered cognitive-behavioural therapy for adolescents with irritable bowel syndrome. BMJ Open. 2019 Jan 24;9(1):e023881. doi: 10.1136/bmjopen-2018-023881.

Reference Type: DERIVED

PMID: 30679293 (View on PubMed)

Other Identifiers

ibs 13-17 år 2013

Identifier Type: -

Identifier Source: org_study_id