Functional Gastrointestinal DisordersNCT05237882
Internet-delivered CBT for Functional Gastrointestinal Disorders (FGID) in Youth: a Single Case Experimental Design
A study testing Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders in people with Functional Gastrointestinal Disorders, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Functional Gastrointestinal Disorders
- 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
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2022to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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-diarreal 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
About this study
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
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.
Read the detailed 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.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders
- Medical subject headings
- Gastrointestinal Diseases
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 group | Role | What they receive |
|---|---|---|
| Children and Adolescents | Experimental | 6 children aged 8-12 years old, 6 adolescents aged 13-17 years old, fulfilling inclusion criteria will be included 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.
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")
Measured: Everyday during baseline (5-15 days before treatment start) and treatment (10 weeks) and during one week at 3 months follow-up
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)
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, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Secondary outcomes (20)
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")
Measured: Everyday during baseline (5-15 days before treatment start) and treatment (10 weeks) and during one week at 3 months follow-up
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, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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)
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, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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)
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, after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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, after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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)
Measured: At baseline, after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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, mid-treatment, end-treatment and 3-months follow-up
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, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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)
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
Measured: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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, mid-treatment, end-treatment and 3-months follow-up
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, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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)
Measured: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
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
Measured: At baseline, after 5 weeks of treatment (mid-treatment), after 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.
- First posted14 Feb 2022
- Study start1 Aug 2022
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- A non-concurrent multi-variate baseline single-case experimental design (SCED) including 6 children and 6 adolescents with their parents. Baseline periods randomized between 5-15 days
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Eva Skovslund Nielsen, Aarhus University Hospital
- Investigators
- Charlotte Ulrikka Rask, Professor, MD, PhD, Study chair, Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237882
- Sponsor's protocol ID
- FGID Single case
- Status last verified
- Dec 2023
- First submitted
- 3 Feb 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nielsen ES, Kallesoe K, Lalouni M, Carlsen AH, Frostholm L, Bonnert M, Rask CU. Trajectories of change in pediatric functional abdominal pain disorders during Internet cognitive behavior therapy: A single case experimental study. J Pain. 2025 Jun;31:105407. doi: 10.1016/j.jpain.2025.105407. Epub 2025 Apr 25.
PubMed 40288508Skovslund 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05237882
- Acronym / sponsor ID
- FGID Single case
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A non-concurrent multi-variate baseline single-case experimental design (SCED) including 6 children and 6 adolescents with their parents. Baseline periods randomized between 5-15 days
| Arm | Type | Receives |
|---|---|---|
| Children and Adolescents | Experimental | Other: Internet delivered cognitive behavioural therapy for functional gastrointestinal disorders6 children aged 8-12 years old, 6 adolescents aged 13-17 years old, fulfilling inclusion criteria will be included |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet delivered cognitive behavioural therapy for functional gastrointestinal disordersThe 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. | Other | Children and Adolescents |
Primary outcome
Single Case Design Outcome: Change in gastrointestinal symptoms measured via Daily Items as part of self-report SCED-Questionnaire
Time frame: Everyday during baseline (5-15 days before treatment start) and treatment (10 weeks) and during one week at 3 months follow-up
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")
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 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
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 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)
20 secondary outcomes
Single Case Design Outcome: Change in catastrophizing, avoidance and control and acceptance via Daily Items, measured as part of self-report SCED-Questionnaire
Time frame: Everyday during baseline (5-15 days before treatment start) and treatment (10 weeks) and during one week at 3 months follow-up
Changes in Quality of life assessed by the Pediatric Quality of Life Inventory
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)
Changes in Quality of life rated by parents assessed by Pediatric Quality of Life Inventory
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)
Changes in Pain intensity measured by the self-report rating scale, Faces pain scale, revised
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)
Changes in Pain intensity rated by parents Measured by the parent-report rating scale, Faces pain scale, revised.
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)
Changes in Overall symptom load measured by the self-report questionnaire Children somatization inventory , short (CSI)
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)
Changes in Overall symptom load rated by parents measured by the parent-report questionnaire Children somatization inventory (parent report), short
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)
Changes in Depression symptoms measured by the self-report questionnaire Mood and Feelings Questionnaire short
Time frame: At baseline, after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Changes in General Anxiety symptoms measured by the self- report questionnaire Spence Children Anxiety Scale short
Time frame: At baseline, after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Changes in General Anxiety rated by parents, Measured by the parent- report questionnaire Spence Children Anxiety Scale short, parent report
Time frame: At baseline, after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
Changes in Specific Gastrointestinal Anxiety, Measured by the self-report questionnaire Visceral Sensitivity Index - Short
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)
Changes in Avoidance and control behaviour measured by the self-report questionnaire irritable bowel syndrome-behavioural response questionnaire
Time frame: At baseline, mid-treatment, end-treatment and 3-months follow-up
Changes in Illness perception Measured by the self-report questionnaire Brief Illness perception Questionnaire
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)
Changes in Illness perception rated by parents, measured by the parent-report questionnaire Illness perception regarding child's symptoms Questionnaire
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)
Changes in Illness worry Measured by the self-report questionnaire Childhood Illness Attitude Scale
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)
Changes in Acceptance, measured by the self-report questionnaire Chronic pain Acceptance Questionnaire -adolescents
Time frame: At baseline, mid-treatment, end-treatment and 3-months follow-up
Changes in PARENTAL Illness Worry measured by the self-report The Health Anxiety by Proxy Scale (HAPYS) questionnaire
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)
Changes in PARENTAL Emotional distress measured by the self-report questionnaire Symptom Check List (SCL-8)
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)
Changes in Adult Response to Child's Symptoms - PARENTS by the self-report questionnaire Adult Response to Children's Symptoms
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)
Changes in School absence / Work absence parent
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Derived from this study: PubMed 40288508Nielsen ES, Kallesoe K, Lalouni M, Carlsen AH, Frostholm L, Bonnert M, Rask CU. Trajectories of change in pediatric functional abdominal pain disorders during Internet cognitive behavior therapy: A single case experimental study. J Pain. 2025 Jun;31:105407. doi: 10.1016/j.jpain.2025.105407. Epub 2025 Apr 25.
- Derived from this study: PubMed 39773759Skovslund 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Ulrikka Rask, Professor, MD, PhD study chair
Aarhus University and Aarhus University Hospital, Child and Adolescents Psychiatry
1 site in 1 country: see every site and its status.
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 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: finished, as of the sponsor's last update on 14 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Single Case Design Outcome: Change in gastrointestinal symptoms measured via Daily Items as part of self-report SCED-Questionnaire (time frame: Everyday during baseline (5-15 days before treatment start) and treatment (10 weeks) and during one week at 3 months follow-up). The study lists 3 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 NCT05237882, 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 14 Dec 2023.