Back to resultsi-CBT Functional Gastrointestinal Disorders in Youth: the Impact of Negative Illness Understanding and Parental Illness Worries
Primary Purpose
Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders, Irritable Bowel Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders
Sponsored by
About this trial
This is an interventional treatment trial for Functional Abdominal Pain Syndrome
Eligibility Criteria
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.
Sites / Locations
- Aarhus University and Aarhus University Hospital, Child and Adolescents PsychiatryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Children and Adolescents
Arm Description
30 children aged 8-12 years old and their parents, 30 adolescents aged 13-17 years old and their parents
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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).
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).
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)
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)
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),
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),
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")
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")
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
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)
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)
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)
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)
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
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
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
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)
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").
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)
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)
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
Full Information
NCT ID
NCT05486585
First Posted
July 6, 2022
Last Updated
November 23, 2022
Sponsor
Aarhus University Hospital
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT05486585
Brief Title
i-CBT Functional Gastrointestinal Disorders in Youth: the Impact of Negative Illness Understanding and Parental Illness Worries
Official Title
Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders in Youth: the Impact of Negative Illness Understanding and Parental Illness Worries
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders, Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An open end pilot study including 30 children and 30 adolescents and their parents (n=60)
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Children and Adolescents
Arm Type
Experimental
Arm Description
30 children aged 8-12 years old and their parents, 30 adolescents aged 13-17 years old and their parents
Intervention Type
Other
Intervention Name(s)
Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in gastrointestinal symptoms assessed by PedsQL Gastro Symptom Scales
Description
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)
Time Frame
At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]
Title
Change in gastrointestinal symptoms rated by parents assessed by PedsQL Gastro Symptom Scales
Description
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)
Time Frame
At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]
Secondary Outcome Measure Information:
Title
Changes in cognitive biases in interpretation and memory of stimuli related to gastrointestinal themes, leisure and school: Picture Task.
Description
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).
Time Frame
At baseline and 10-weeks of treatment (end of treatment)
Title
Changes in cognitive biases in interpretation and memory of stimuli related to gastrointestinal themes, leisure and school: Health Norms sorting Task.
Description
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).
Time Frame
At baseline and 10-weeks of treatment (end of treatment)
Title
Changes in Quality of life assessed by the Pediatric Quality of Life Inventory
Description
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)
Time Frame
At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in Quality of life rated by parents assessed by Pediatric Quality of Life Inventory
Description
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
Time Frame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in Pain intensity measured by the self-report rating scale, Faces pain scale, revised
Description
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),
Time Frame
At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in Pain intensity rated by parents Measured by the parent-report rating scale, Faces pain scale, revised
Description
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),
Time Frame
At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]
Title
Changes in Overall symptom load measured by the self-report questionnaire Children somatization inventory , short (CSI)
Description
The questionnaire consist of 24 items Answered on a 5 point scale from 0 ("not at all") to 4 ("a whole lot")
Time Frame
At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in Overall symptom load rated by parents measured by the parent-report questionnaire Children somatization inventory (parent report), short
Description
The questionnaire consists of 24 items Answered on a 5 point scale from 0 ("not at all") to 4 ("a whole lot")
Time Frame
At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in Depression symptoms measured by the self-report questionnaire Mood and Feelings Questionnaire short
Description
The questionnaire consists of 13 items, answered on a 3 point scale: not true / sometimes true / true
Time Frame
At baseline, 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in General Anxiety symptoms measured by the self- report questionnaire Spence Children Anxiety Scale short
Description
A 19 item-questionnaire answered on a 4 point scale from 0(never) to 3 (always)
Time Frame
At baseline, 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in General Anxiety rated by parents, Measured by the parent- report questionnaire Spence Children Anxiety Scale short, parent report
Description
A 19 item-questionnaire answered on a 4 point scale from 0(never) to 3 (always)
Time Frame
At baseline, 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]
Title
Changes in Specific Gastrointestinal Anxiety, Measured by the self-report questionnaire Visceral Sensitivity Index -Short
Description
A 7 item-questionnaire answered on a 5 point scale from 0 (don't agree at all) to 5 (totally agree)
Time Frame
At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in Avoidance and control behaviour measured by the self-report questionnaire irritable bowel syndrome behavioural response questionnaire
Description
A 11 item-questionnaire answered on a 7 point likert scale from 1(never) to 7(always)
Time Frame
At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in Illness perception Measured by the self-report questionnaire Brief Illness perception Questionnaire
Description
A questionnaire with 11 items answered on a scale from 0 - 10
Time Frame
At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in Illness perception rated by parents, measured by the parent-report questionnaire Illness perception regarding child's symptoms Questionnaire
Description
A questionnaire with 11 items answered on a scale from 0 - 10
Time Frame
At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in Illness worry Measured by the self-report questionnaire Childhood Illness Attitude Scale
Description
The fear-factor domain of the questionnaire is used, it consists of 11 items, answers: never, sometimes or always
Time Frame
At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in Acceptance, measured by the self-report questionnaire Chronic pain Acceptance Questionnaire -adolescents
Description
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)
Time Frame
At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in PARENTAL Illness Worry measured by the self-report The Health Anxiety by Proxy Scale (HAPYS) questionnaire
Description
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").
Time Frame
At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in PARENTAL Emotional distress measured by the self-report questionnaire Symptom Check List (SCL-8)
Description
The questionnaire consists of 8 items answered on a 5 point scale from 0 (not at all) to 4 (a whole lot)
Time Frame
At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in Adult Response to Child's Symptoms - PARENTS by the self-report questionnaire Adult Response to Children's Symptoms
Description
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)
Time Frame
At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Title
Changes in School absence / Work absence parent
Description
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
Time Frame
At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Other Pre-specified Outcome Measures:
Title
Treatment satisfaction by the self-report questionnaire Modified Experience of Service Questionnaire Modified Experience of Service Questionnaire
Description
10 items rated either true, partly true, not true or don't know and 3 open end questions
Time Frame
At 10 weeks of treatment (End of treatment)
Title
Adverse events
Description
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.
Time Frame
At 10 weeks of treatment (End of treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Nielsen, MD
Phone
+45 23882426
Email
eniels@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Hansen Kallesøe, MD, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Ulrikka Rask, Professor, MD, PhD
Organizational Affiliation
Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Skovslund Nielsen
12. IPD Sharing Statement
Learn more about this trial
i-CBT Functional Gastrointestinal Disorders in Youth: the Impact of Negative Illness Understanding and Parental Illness Worries
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