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Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders

NCT ID: NCT02113605

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-11-30

Brief Summary

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The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.

Detailed Description

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Conditions

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Functional Gastrointestinal Disorders (FGID) FGID According to the Rome III Criteria Irritable Bowel Syndrome (IBS) Functional Abdominal Pain Functional Dyspepsia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive behavior therapy

All included children are treated with a face-to-face exposure-based cognitive behaviour therapy for 10 weeks. There will be no comparison arm.

Group Type EXPERIMENTAL

Cognitive behavior therapy

Intervention Type OTHER

Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment

Interventions

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Cognitive behavior therapy

Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 8-12 years
* A diagnosis of a functional gastrointestinal disorder by a treating physician

Exclusion Criteria

* Concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder.
* Psychiatric disorder more urgent to treat than the abdominal pain.
* On-going psychological treatment.
* Absence from school more than 40 %.
* Ongoing maltreatment, violence or severe parental psychiatric illness.
* Pronounced language or learning difficulties that hinder the child to benefit from the treatment.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Ola Olen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ola Olén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Child and Adolescent Psychiatry in Stockholm

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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FGID Child Pilot-0

Identifier Type: -

Identifier Source: org_study_id