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

NCT ID: NCT05486585

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-17
• Study Completion Date: 2025-06-30

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.

Detailed 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.

Conditions

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

Study Design

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

Study Groups

Children and Adolescents

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

Group Type: EXPERIMENTAL

Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders

Intervention Type: 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.

Interventions

Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eva Skovslund Nielsen

PhD-Student, Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charlotte Ulrikka Rask, Professor, MD, PhD

Role: STUDY_CHAIR

Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry

Locations

Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry

Aarhus, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 39773759 (View on PubMed)

Other Identifiers

FGID pilot test

Identifier Type: -

Identifier Source: org_study_id