Internet-delivered CBT for Functional Gastrointestinal Disorders (FGID) in Youth: a Single Case Experimental Design
NCT ID: NCT05237882
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2022-08-01
2023-06-15
Brief Summary
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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
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Children and Adolescents
6 children aged 8-12 years old, 6 adolescents aged 13-17 years old, fulfilling inclusion criteria will be included
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
8 Years
17 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Aarhus University Hospital
OTHER
Responsible Party
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Eva Skovslund Nielsen
PhD-Student, Medical doctor
Principal Investigators
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Charlotte Ulrikka Rask, Professor, MD, PhD
Role: STUDY_CHAIR
Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry
Locations
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Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry
Aarhus, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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FGID Single case
Identifier Type: -
Identifier Source: org_study_id