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

NCT ID: NCT02475096

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-11-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-delivered CBT

Children and parents will receive 10 weekly modules of internet-delivered CBT (Cognitive Behavior Therapy). Parents will also receive 10 weekly specific modules for parents. Main components in the modules directed at children and parents are exposure for symptoms, feared stimuli and situations. The parents modules contain information on how they can support their children in the treatment and is based on social learning theory. Therapist support is provided through written messages within the secure platform. Therapists are trained CBT-psychologists.

Group Type: EXPERIMENTAL

Internet-delivered CBT

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children between 8-12 years (until their 13th birthday) who have been diagnosed with any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional abdominal pain according to the Rome III criteria.
• Any psychopharmacological medication should be stable since 1 month.
• Parents and children need to master Swedish, have access to a computer with internet access, and be willing to participate in 10 weeks of treatment with homework.

Exclusion Criteria

• Simultaneous presence of serious somatic disease and / or if the child meets the criteria for other organic disease which better explains the symptoms.
• Psychiatric or social problems that are considered serious and in need of a more intense treatment than ICBT leads to exclusion. Children with higher school absenteeism than 40% will not be included. Neither will children who have an ongoing psychological treatment be included,

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Ola Olen

PhD MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ola Olén, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Child and Adolescent Psychiatry in Stockholm

Stockholm, Stockholms Lans Landsting, Sweden

Child and Adolescent Psychiatry in Stockholm

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

Pilot child ICBT FGID

Identifier Type: -

Identifier Source: org_study_id