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

Karolinska Institute logo

Karolinska Institute

Status

Completed

Conditions

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

Treatments

Other: Cognitive behavior therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02113605
FGID Child Pilot-0

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

8 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Cognitive behavior therapy
Experimental group
Description:
All included children are treated with a face-to-face exposure-based cognitive behaviour therapy for 10 weeks. There will be no comparison arm.
Treatment:
Other: Cognitive behavior therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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