i-CBT Functional Gastrointestinal Disorders in Youth: the Impact of Negative Illness Understanding and Parental Illness Worries

Irritable Bowel Syndrome Clinical Trial

Official title:

Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders in Youth: the Impact of Negative Illness Understanding and Parental Illness Worries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05486585
• Other study ID #: FGID pilot test
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Aarhus University Hospital
• Contact: Eva Nielsen, MD
• Phone: +45 23882426
• Email: eniels[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current study, embedded in The Danish FGID Treatment Study, is to test Danish versions of Swedish i-CBT programs for children and adolescents with FGID in a Danish clinical context and to further evaluate the presence and impact of important psychological and parental factors.

Description:

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.

Parental behavior can significantly influence the young person's perception of bodily symptoms, which are thought to be part of development and maintenance of symptoms FGID. So are cognitive biases which are distortions in attention, memory and interpretation.

The programs involve both the youth and their parents, which provides a unique possibility, to examine illness-related cognitive biases and the effectiveness of graded exposure in youths with FGID with an additional focus on parental distress and illness worries for treatment adherence and outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• 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-diarrheal 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

• Abdominal Pain
• Digestive System Diseases
• Functional Abdominal Pain Syndrome
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Irritable Bowel Syndrome
• Syndrome

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 Modified Experience of Service Questionnaire	10 items rated either true, partly true, not true or don't know and 3 open end questions	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	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, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]
Secondary	Changes in cognitive biases in interpretation and memory of stimuli related to gastrointestinal themes, leisure and school: Picture Task.	Online experimental task with a picture task, with 15 pictures rated on emotional valence (0 negative, 100 positive), physical reaction (1 nota at all, 7 very much) and relatability to own life (1 not at all, 7 very much). Pictures are then recalled and rated on emotional valence (0 negative, 100 positive) and physical reaction (1 nota at all, 7 very much). Lastly pictures are recognised from unfamiliar pictures and rated on difficulty (1 not at all, 7 very much) and confidence (1 not at all, 7 very much).	At baseline and 10-weeks of treatment (end of treatment)
Secondary	Changes in cognitive biases in interpretation and memory of stimuli related to gastrointestinal themes, leisure and school: Health Norms sorting Task.	Online experimental task with FGID-specific version of the Health Norms Sorting Task, Participants sort 20 words as healthy or no longer healthy, recall as many words as possible and lastly recognise from previously unfamiliar words while rating on difficulty (1 not at all, 7 very much) and confidence (1 not at all, 7 very much).	At baseline and 10-weeks of treatment (end of treatment)
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, 5 weeks of treatment (mid-treatment), 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)	Time Frame: At baseline, 5 weeks of treatment (mid-treatment), 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, 5 weeks of treatment (mid-treatment), 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, 5 weeks of treatment (mid-treatment), 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, 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, 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	A 19 item-questionnaire answered on a 4 point scale from 0(never) to 3 (always)	At baseline, 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, 5 weeks of treatment (mid-treatment), 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, 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 Measured by the self-report questionnaire Brief Illness perception Questionnaire	A questionnaire with 11 items answered on a scale from 0 - 10	At baseline, 5 weeks of treatment (mid-treatment), 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 fear-factor domain of the questionnaire is used, it consists of 11 items, answers: never, sometimes or always	At baseline, 5 weeks of treatment (mid-treatment), 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, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (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, 5 weeks of treatment (mid-treatment), 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 consists 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, 5 weeks of treatment (mid-treatment), 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 report for children aged 8-12 years, self-report for adolescents aged 13-17 years, self-report for parents	At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)