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i-CBT Functional Gastrointestinal Disorders in Youth: the Impact of Negative Illness Understanding and Parental Illness Worries

A

Aarhus University Hospital

Status

Enrolling

Conditions

Irritable Bowel Syndrome
Functional Gastrointestinal Disorders
Functional Abdominal Pain Syndrome

Treatments

Other: Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders

Study type

Interventional

Funder types

Other

Identifiers

NCT05486585
FGID pilot test

Details and patient eligibility

About

The aim of the current study, embedded in The Danish FGID Treatment Study, is to test Danish versions of Swedish i-CBT programs for children and adolescents with FGID in a Danish clinical context and to further evaluate the presence and impact of important psychological and parental factors.

Full description

Functional gastrointestinal disorders (FGID) are common among children and adolescents. They affect quality of life, cause functional disability, school absence and high health care use.

Parental behavior can significantly influence the young person's perception of bodily symptoms, which are thought to be part of development and maintenance of symptoms FGID. So are cognitive biases which are distortions in attention, memory and interpretation.

The programs involve both the youth and their parents, which provides a unique possibility, to examine illness-related cognitive biases and the effectiveness of graded exposure in youths with FGID with an additional focus on parental distress and illness worries for treatment adherence and outcome.

Enrollment

60 estimated patients

Sex

All

Ages

8 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Child age: 8-12 years, adolescents: 13 - 17 years
  • A primary diagnosis according to the ROME-IV criteria of one of the FGID sub-types: Irritable bowel syndrome (IBS) or functional abdominal pain not-otherwise-specified (FAP-NOS)
  • The diagnosis should be documented by their regular physician in the somatic setting, and recommended routine medical investigations should be evaluated as normal or without clinical significance (include growth; blood samples including TSH, total IgA, IgA tissue transglutaminase, complete blood count, C-reactive protein analysis, liver enzymes; and fecal calprotectin)
  • Stable dosage of FGID-related medication such as laxatives, anti-diarrheal medication or pain-modulating psychopharmacological medication during the past month.

Exclusion criteria

  • Another disease that explains the symptoms;
  • Severe psychiatric or social problems (e.g., high level of suicidal ideation or ongoing abuse);
  • Ongoing psychological treatment;
  • Insufficient language or computer skills (patients and parents);
  • Severe family problems (e.g. child abuse, parental substance abuse or severe psychiatric illness, ongoing custody fight)
  • School absence of more than 40% over the past month.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Children and Adolescents
Experimental group
Description:
30 children aged 8-12 years old and their parents, 30 adolescents aged 13-17 years old and their parents
Treatment:
Other: Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders

Trial contacts and locations

1

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Central trial contact

Eva Nielsen, MD; Karen Hansen Kallesøe, MD, PhD

Data sourced from clinicaltrials.gov

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