NCT05237882

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

Internet-delivered CBT for Functional Gastrointestinal Disorders (FGID) in Youth - A Single Case Experimental Design Study Embedded in The Danish FGID Treatment Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

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 children and 6 adolescents with their parents. Participants will be randomly assigned to a baseline length with a duration between 5-15 days. The design, using a multi-variate baseline, enables each participant to form their own control as outcomes during the baseline are compared with outcomes during treatment. This means that if treatment is effectual a change in outcome measures will show during the treatment period no matter when the treatment period was started. Outcome will be assessed daily from baseline to end of treatment using electronic self-report questionnaire, with a last, one week long, daily assessment at 3-month follow-up. The questionnaire is designed for this specific study and consist of 8 items (modified to a daily question) from validated questionnaires, the scale is changed to an 11 point scale from 0(not at all) to 10(all the time) Outcome are: abdominal symptoms (2 items from PedsQL Gastro 9 items questionnaire), symptom catastrophizing (2 items from Visceral Short sensitivity Index questionnaire), avoidance and control behavior (2 items from IBS Behavioural Response Questionnaire), and symptom acceptance(2 items from Chronic Pain Acceptance Questionnaire for Adolescents 8-items) In addition, a more comprehensive battery of questionnaires will be completed by the children and adolescents and the parent, respectively, at baseline, mid-treatment, end of treatment and at 3-month follow-up.

Conditions

• Functional Gastrointestinal Disorders

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2022-02-14
• Last updated: 2023-12-14

Locations

1 site across 1 country: Denmark