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

NCT05486585 | Active Not Recruiting

• 1 other identifier: FGID pilot test
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Functional Abdominal Pain Syndrome; Functional Gastrointestinal Disorders; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Change in gastrointestinal symptoms assessed by PedsQL Gastro Symptom Scales

  The self-report questionnaire revised version of PedsQL Gastro Symptom Scales, with 9 items. Answered on a 5 point scale from 0 ("never") to 4 ("almost always)

  At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]

• Change in gastrointestinal symptoms rated by parents assessed by PedsQL Gastro Symptom Scales

  The parent-report questionnaire revised version of PedsQL Gastro Symptom Scales, with 9 items. Answered on a 5 point scale from 0 ("never") to 4 ("almost always)

  At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]

Secondary Outcomes (21)

• Changes in cognitive biases in interpretation and memory of stimuli related to gastrointestinal themes, leisure and school: Picture Task.

  At baseline and 10-weeks of treatment (end of treatment)

• Changes in cognitive biases in interpretation and memory of stimuli related to gastrointestinal themes, leisure and school: Health Norms sorting Task.

  At baseline and 10-weeks of treatment (end of treatment)

• Changes in Quality of life assessed by the Pediatric Quality of Life Inventory

  At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

• Changes in Quality of life rated by parents assessed by Pediatric Quality of Life Inventory

  Time Frame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

• Changes in Pain intensity measured by the self-report rating scale, Faces pain scale, revised

  At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

Other Outcomes (2)

• Treatment satisfaction by the self-report questionnaire Modified Experience of Service Questionnaire Modified Experience of Service Questionnaire

  At 10 weeks of treatment (End of treatment)

• Adverse events

  At 10 weeks of treatment (End of treatment)

Study Arms (1)

Children and Adolescents

EXPERIMENTAL

30 children aged 8-12 years old and their parents, 30 adolescents aged 13-17 years old and their parents

Other: Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders

Interventions

Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders OTHER

The offered treatment will be the Danish versions of the Swedish i-CBT programs for children. The child i-CBT program consists of 10 modules for the child and 10 for parents. The adolescent i-CBT program consists of 10 modules for the adolescent and 5 modules for the parents. Child and adolescents modules compose of exposure exercises for symptoms, behavioural analyses and affect labelling and are adjusted for the specific age group. Parent modules aim at supporting parents in helping their child to engage in the challenging exposure exercises. The family needs to select one parent to participate in the parent program. The participants will be expected to use approximately 4 hours per week. The programs will be delivered over ten weeks, and therapist support will be provided on a weekly basis.

Children and Adolescents

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry

Aarhus, Denmark

Location

Related Publications (1)

• Skovslund Nielsen E, Kallesoe K, Bennedsen Gehrt T, Bjerre-Nielsen E, Lalouni M, Frostholm L, Bonnert M, Rask CU. Trajectories of Change, Illness Understanding, and Parental Worries in Children and Adolescents Undergoing Internet-Delivered Cognitive-Behavioral Therapy for Functional Abdominal Pain Disorders: Protocol for a Single-Case Design and Explorative Pilot Study. JMIR Res Protoc. 2025 Jan 7;14:e58563. doi: 10.2196/58563.

  PMID: 39773759 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases

Study Officials

• Charlotte Ulrikka Rask, Professor, MD, PhD

  Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-Student, Medical doctor

Model Details: An open end pilot study including 30 children and 30 adolescents and their parents (n=60)

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 3, 2022
• Study Start: November 17, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-01

Locations

DK (1)