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Functional Abdominal Pain SyndromeNCT05486585

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

A study testing Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders in people with Functional Abdominal Pain Syndrome and Functional Gastrointestinal Disorders, run by Aarhus University Hospital at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 8 to 17 years
What is being tested?
Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteDenmark
Study dates
17 Nov 2022to Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry

    Aarhus

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders
Medical subject headings
Gastrointestinal Diseases, Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet delivered cognitive behavioural therapy for functional gastrointestinal disordersOther

    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.

Study groups in NCT05486585
Study groupRoleWhat they receive
Children and AdolescentsExperimental30 children aged 8-12 years old and their parents, 30 adolescents aged 13-17 years old and their parents
Receives: Other: Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]

  2. 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)

    Measured: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]

Secondary outcomes (21)

  1. 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).

    Measured: At baseline and 10-weeks of treatment (end of treatment)

  2. 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).

    Measured: At baseline and 10-weeks of treatment (end of treatment)

  3. 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)

    Measured: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  4. 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)

    Measured: Time Frame: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  5. 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),

    Measured: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  6. 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),

    Measured: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]

  7. 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")

    Measured: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  8. 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")

    Measured: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  9. 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

    Measured: At baseline, 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  10. 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)

    Measured: At baseline, 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  11. 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)

    Measured: At baseline, 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)]

  12. 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)

    Measured: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  13. 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)

    Measured: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  14. 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

    Measured: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  15. 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

    Measured: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  16. 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

    Measured: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  17. 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)

    Measured: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  18. 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").

    Measured: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  19. 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)

    Measured: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  20. 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)

    Measured: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

  21. 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

    Measured: At baseline, 5 weeks of treatment (mid-treatment), 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2022
  2. Study start17 Nov 2022
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
An open end pilot study including 30 children and 30 adolescents and their parents (n=60)
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05486585
Sponsor's protocol ID
FGID pilot test
Status last verified
Jan 2025
First submitted
6 Jul 2022
Last updated
11 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nielsen ES, Kallesoe KH, Frostholm L, Jonsson IM, Johansen KB, Lalouni M, Bonnert M, Rask CU. Internet-delivered cognitive behavioral therapy for pediatric functional abdominal pain disorders: Parental factors in treatment response. Internet Interv. 2026 Apr 20;44:100941. doi: 10.1016/j.invent.2026.100941. eCollection 2026 Jun.

    PubMed 42057915

  • 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.

    PubMed 39773759

Questions about this trial

What is this clinical trial studying?

A study testing Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders in people with Functional Abdominal Pain Syndrome and Functional Gastrointestinal Disorders, run by Aarhus University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in gastrointestinal symptoms assessed by PedsQL Gastro Symptom Scales (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)]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05486585, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.

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