Internet-delivered CBT for Functional Gastrointestinal Disorders (FGID) in Youth: a Single Case Experimental Design

NCT05237882 | Completed

• 1 other identifier: FGID Single case
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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. Despite this there is a lack in treatment options. The aim of the current study, embedded in The Danish FGID Treatment Study, is to investigate the detailed course of efficacy of Danish versions of Swedish Internet based cognitive behavioural therapy (i-CBT) programs for children and adolescents with FGID in a Danish clinical context. This will be done using a single case design study. Along with this, the impact of parental illness worries will be investigated.

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (3)

• Single Case Design Outcome: Change in gastrointestinal symptoms measured via Daily Items as part of self-report SCED-Questionnaire

  The SCED-Questionnaire consists of 8 daily items about Gastrointestinal symptoms, catastrophizing, Avoidance and control, acceptance. Answered on a 11 point scale from 0 ("not at all") to 10 ("all the time")

  Everyday during baseline (5-15 days before treatment start) and treatment (10 weeks) and during one week at 3 months follow-up

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

Secondary Outcomes (20)

• Single Case Design Outcome: Change in catastrophizing, avoidance and control and acceptance via Daily Items, measured as part of self-report SCED-Questionnaire

  Everyday during baseline (5-15 days before treatment start) and treatment (10 weeks) and during one week at 3 months follow-up

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

  At baseline, after 5 weeks of treatment (mid-treatment), after 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

  At baseline, after 5 weeks of treatment (mid-treatment), after 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)

• Changes in Pain intensity rated by parents Measured by the parent-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

  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

6 children aged 8-12 years old, 6 adolescents aged 13-17 years old, fulfilling inclusion criteria will be included

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-diarreal 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 (2)

• Nielsen ES, Kallesoe K, Lalouni M, Carlsen AH, Frostholm L, Bonnert M, Rask CU. Trajectories of change in pediatric functional abdominal pain disorders during Internet cognitive behavior therapy: A single case experimental study. J Pain. 2025 Jun;31:105407. doi: 10.1016/j.jpain.2025.105407. Epub 2025 Apr 25.

  PMID: 40288508 DERIVED

• 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

Condition Hierarchy (Ancestors)

Digestive System 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: A non-concurrent multi-variate baseline single-case experimental design (SCED) including 6 children and 6 adolescents with their parents. Baseline periods randomized between 5-15 days

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: August 1, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

DK (1)