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Internet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot Study

NCT02475096 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-03-03

No results posted yet for this study

Summary

This pilot-study aims to evaluate the effect size and feasibility of internet-delivered cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant functional gastrointestinal disorders (e.g. irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria). The main component investigated in this study is exposure for gastrointestinal symptoms and for feared stimuli and situations. Children will participate along with one of their parents in the treatment. The parents will also receive specific modules with information on how to support their child in the treatment.

Conditions

  • Functional Gastrointestinal Disorders

Interventions

BEHAVIORAL

Internet-delivered CBT

The treatment is based on an internet-delivered CBT-treatment for adults with IBS and on the adapted version for adolescents with functional gastrointestinal disorders. The protocol has been tested in an open face-to-face CBT study of children aged 8-12 years (n=20) with promising results. Main component in the treatment is exposure for symptoms. The purpose of the treatment is to reduce fearful and anxious responses to symptoms and lessen avoidance of symptoms in the child, and to teach the parents how parental behavior can influence symptoms in children as well as how to support exposure. 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.

Sponsors & Collaborators

Principal Investigators

  • Ola Olén, MD PhD · Karolinska Institutet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02475096 on ClinicalTrials.gov