Clinical trial NCT05486585: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Functional Abdominal Pain Syndrome
Functional Gastrointestinal Disorders
Irritable Bowel Syndrome
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2022-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An open end pilot study including 30 children and 30 adolescents and their parents (n=60)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in gastrointestinal symptoms assessed by PedsQL Gastro Symptom Scales
timeFrame: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]
measure: Change in gastrointestinal symptoms rated by parents assessed by PedsQL Gastro Symptom Scales
timeFrame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]
Secondary outcomes:
measure: Changes in cognitive biases in interpretation and memory of stimuli related to gastrointestinal themes, leisure and school: Picture Task.
timeFrame: At baseline and 10-weeks of treatment (end of treatment)
measure: Changes in cognitive biases in interpretation and memory of stimuli related to gastrointestinal themes, leisure and school: Health Norms sorting Task.
timeFrame: At baseline and 10-weeks of treatment (end of treatment)
measure: Changes in Quality of life assessed by the Pediatric Quality of Life Inventory
timeFrame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in Quality of life rated by parents assessed by Pediatric Quality of Life Inventory
timeFrame: Time Frame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in Pain intensity measured by the self-report rating scale, Faces pain scale, revised
timeFrame: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in Pain intensity rated by parents Measured by the parent-report rating scale, Faces pain scale, revised
timeFrame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]
measure: Changes in Overall symptom load measured by the self-report questionnaire Children somatization inventory , short (CSI)
timeFrame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in Overall symptom load rated by parents measured by the parent-report questionnaire Children somatization inventory (parent report), short
timeFrame: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in Depression symptoms measured by the self-report questionnaire Mood and Feelings Questionnaire short
timeFrame: At baseline, 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in General Anxiety symptoms measured by the self- report questionnaire Spence Children Anxiety Scale short
timeFrame: At baseline, 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in General Anxiety rated by parents, Measured by the parent- report questionnaire Spence Children Anxiety Scale short, parent report
timeFrame: At baseline, 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]
measure: Changes in Specific Gastrointestinal Anxiety, Measured by the self-report questionnaire Visceral Sensitivity Index -Short
timeFrame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in Avoidance and control behaviour measured by the self-report questionnaire irritable bowel syndrome behavioural response questionnaire
timeFrame: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in Illness perception Measured by the self-report questionnaire Brief Illness perception Questionnaire
timeFrame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in Illness perception rated by parents, measured by the parent-report questionnaire Illness perception regarding child's symptoms Questionnaire
timeFrame: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in Illness worry Measured by the self-report questionnaire Childhood Illness Attitude Scale
timeFrame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in Acceptance, measured by the self-report questionnaire Chronic pain Acceptance Questionnaire -adolescents
timeFrame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in PARENTAL Illness Worry measured by the self-report The Health Anxiety by Proxy Scale (HAPYS) questionnaire
timeFrame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in PARENTAL Emotional distress measured by the self-report questionnaire Symptom Check List (SCL-8)
timeFrame: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in Adult Response to Child's Symptoms - PARENTS by the self-report questionnaire Adult Response to Children's Symptoms
timeFrame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
measure: Changes in School absence / Work absence parent
timeFrame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Other outcomes:
measure: Treatment satisfaction by the self-report questionnaire Modified Experience of Service Questionnaire Modified Experience of Service Questionnaire
timeFrame: At 10 weeks of treatment (End of treatment)
measure: Adverse events
timeFrame: At 10 weeks of treatment (End of treatment)
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry
Study officials:
affiliation: Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry
name: Charlotte Ulrikka Rask, Professor, MD, PhD
role: STUDY_CHAIR
References: