Status:
COMPLETED
Internet-delivered CBT for Functional Gastrointestinal Disorders (FGID) in Youth: a Single Case Experimental Design
Lead Sponsor:
Aarhus University Hospital
Collaborating Sponsors:
Karolinska Institutet
Conditions:
Functional Gastrointestinal Disorders
Eligibility:
All Genders
8-17 years
Phase:
NA
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 ...
Detailed Description
A non-concurrent multi-variate baseline single-case experimental design study (SCED) will be conducted. It will consist of a baseline phase, a treatment phase and a follow up phase, including 6 childr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05237882
Start Date
August 1 2022
End Date
June 15 2023
Last Update
December 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry
Aarhus, Denmark