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

Functional Gastrointestinal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05237882
• Other study ID #: FGID Single case
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: June 15, 2023

Study information

• Verified date: December 2023
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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-diarreal 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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment satisfaction by the self-report questionnaire Modified Experience of Service Questionnaire	10 items rated either true, partly true, not true or don't know and 3 open end questions about experience of treatment,	At 10 weeks of treatment (End of treatment)
Other	Adverse events	Open end questions. Parents to children aged 8-12 years will answer on behalf of their children and adolescents aged 13-17 years will answer themselves.	At 10 weeks of treatment (End of treatment)
Primary	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
Primary	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)
Primary	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	Single Case Design Outcome: Change in catastrophizing, avoidance and control and acceptance via Daily Items, measured as part of self-report SCED-Questionnaire	Measured as part of self-report SCED-Questionnaire 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
Secondary	Changes in Quality of life assessed by the Pediatric Quality of Life Inventory	The self-report questionnaire Pediatric Quality of Life Inventory 8-12-year version for children, 13-18-year version for adolescents. 23 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	Changes in Quality of life rated by parents assessed by Pediatric Quality of Life Inventory	The parent-report questionnaire Pediatric Quality of Life Inventory for parents, (Parent report for children aged 8-12 years, and parent report for adolescents aged 13-17 years) . 23 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	Changes in Pain intensity measured by the self-report rating scale, Faces pain scale, revised	The scale consists of 6 faces representing least to most pain, and each face is connected to a number from 0 (no pain) - 10 (most pain),	At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary	Changes in Pain intensity rated by parents Measured by the parent-report rating scale, Faces pain scale, revised.	The scale consists of 6 faces representing least to most pain, and each face is connected to a number from 0 (no pain) - 10 (most pain),	At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary	Changes in Overall symptom load measured by the self-report questionnaire Children somatization inventory , short (CSI)	The questionnaire consist of 24 items Answered on a 5 point scale from 0 ("not at all") to 4 ("a whole lot")	At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary	Changes in Overall symptom load rated by parents measured by the parent-report questionnaire Children somatization inventory (parent report), short	The questionnaire consists of 24 items Answered on a 5 point scale from 0 ("not at all") to 4 ("a whole lot")	At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary	Changes in Depression symptoms measured by the self-report questionnaire Mood and Feelings Questionnaire short	The questionnaire consists of 13 items, answered on a 3 point scale: not true / sometimes true / true	At baseline, after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary	Changes in General Anxiety symptoms measured by the self- report questionnaire Spence Children Anxiety Scale short	A 19 item-questionnaire answered on a 4 point scale from 0(never) to 3 (always)	At baseline, after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary	Changes in General Anxiety rated by parents, Measured by the parent- report questionnaire Spence Children Anxiety Scale short, parent report	a19 item-questionnaire answered on a 4 point scale from 0(never) to 3 (always)	At baseline, after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary	Changes in Specific Gastrointestinal Anxiety, Measured by the self-report questionnaire Visceral Sensitivity Index - Short	A 7 item-questionnaire answered on a 5 point scale from 0 (don't agree at all) to 5 (totally agree)	At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary	Changes in Avoidance and control behaviour measured by the self-report questionnaire irritable bowel syndrome-behavioural response questionnaire	A 11 item-questionnaire answered on a 7 point likert scale from 1(never) to 7(always)	At baseline, mid-treatment, end-treatment and 3-months follow-up
Secondary	Changes in Illness perception Measured by the self-report questionnaire Brief Illness perception Questionnaire	A questionnaire with 11 items answered on a scale from 0 - 10	At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary	Changes in Illness perception rated by parents, measured by the parent-report questionnaire Illness perception regarding child's symptoms Questionnaire	A questionnaire with 11 items answered on a scale from 0 - 10	At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary	Changes in Illness worry Measured by the self-report questionnaire Childhood Illness Attitude Scale	The cognitive domain of the questionnaire is used, it consists of 11 items, answers: never, sometimes or 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	Changes in Acceptance, measured by the self-report questionnaire Chronic pain Acceptance Questionnaire -adolescents	Two items from the self-report questionnaire Chronic pain Acceptance Questionnaire -adolescents are used. 2 selected items, answered on a 5-point scale from 0 (never true) to 4 (always true)	At baseline, mid-treatment, end-treatment and 3-months follow-up
Secondary	Changes in PARENTAL Illness Worry measured by the self-report The Health Anxiety by Proxy Scale (HAPYS) questionnaire	Parental illness worry for their child, measured by the self-report The questionnaire covers 26 items about health anxiety by proxy, rated on a five-point scale (from "not at all"/"never" to "a whole lot"/"most of the time"). And five items about the impact of the worries rated on a four-point scale (from "no" to "yes, severely").	At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary	Changes in PARENTAL Emotional distress measured by the self-report questionnaire Symptom Check List (SCL-8)	The questionnaire consist of 8 items answered on a 5 point scale from 0 (not at all) to 4 (a whole lot)	At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary	Changes in Adult Response to Child's Symptoms - PARENTS by the self-report questionnaire Adult Response to Children's Symptoms	Protect and Monitor scale from the the questionnaire Adult Response to Children's Symptoms used, 15 items answered on a 5 point scale from 0(never) to 4 (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	Changes in School absence / Work absence parent	Question about Hours / Days missed from school/work last month. Parental rated for children aged 8-12 years, self-rated for adolescents aged 13-17 years, self-rated for parents	At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)