Functional Abdominal Pain SyndromeNCT05945251
ICBT for Children With FAPDs - the Child's Pain Regulation
An observational study of Functional Abdominal Pain Syndrome, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Functional abdominal pain disorders (FAPDs) in children are common (14%) and abdominal pain has increased rapidly in children during the last ten years in Sweden. Many children with FAPDs have low quality of life, missed school days, and about 30-40% suffer from psychiatric comorbidity. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Abdominal Pain Syndrome
- What is being tested?
- Internet-delivered cognitive behavioral therapy
- How many people
- 84 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2023to 1 Sep 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child
Study population: Children (n=40) aged 8-17 with FAPDs who are patients at BUP Internetbehandling within the Child and Adolescent Psychiatry in Stockholm will be included in the study. Their behavioral and neural pain mechanisms will be assessed before and after Internet-CBT. We will also recruit healthy control children (n=40) aged 8-17 to compare the pain regulation between the groups. First, we will ask whether there are healthy siblings to the participating children with FAPDs that are willing to participate. If we don't get enough children by asking siblings, social media will be used in the recruitment.
Who may be able to join
- Children 8-17 years with FAPDs: Have been offered treatment at BUP Internetbehandling for FAPDs.
- Children 8-17 years without FAPDs: Not affected by recurrent (every week) or persistant pain during the last year.
Who cannot join
- Contraindication for MR (metal implant or metal object in body, claustrophobia, pregnancy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualized Online Cognitive Behavioral Therapy for Children With Functional Abdominal Pain Disorders - the Child's Pain Regulation
Functional abdominal pain disorders (FAPDs) in children are common (14%) and abdominal pain has increased rapidly in children during the last ten years in Sweden. Many children with FAPDs have low quality of life, missed school days, and about 30-40% suffer from psychiatric comorbidity. FAPDs are often sustained into adulthood and a large Swedish cohort study showed that abdominal pain during childhood is an independent strong predictor anxiety and depression later in life. Internet-cognitive behavioral therapy (Internet-CBT) can improve FAPD symptoms, but a significant number of children does not respond to the treatment.
We will here determine the pain regulation in children with FAPDs, compared with healthy controls, and assess:
Read more
What aspects of the child's pain regulation is related to improvement for children with FAPDs engaging in Internet-CBT?
Does some aspects of the child's pain regulation change during treatment?
- Conditions
- Functional Abdominal Pain Syndrome
- Being tested
- Internet-delivered cognitive behavioral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered cognitive behavioral therapyOther
Ten weekly modules for children and ten weekly modules for parents. Exposure-based cognitive behavioral therapy delivered online with asynchronous support via text messages from psychologists.
| Study group | Role | What they receive |
|---|---|---|
| FAPDs | Children 8-17 years with FAPDs Receives: Other: Internet-delivered cognitive behavioral therapy | |
| Controls | Children 8-17 years without FAPDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold on navel
Algometer pressure (in kPa) for the pain threshold
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Unpleasantness of pressure pain threshold on navel
Children rate their unpleasantness on a scale 0-10
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Secondary outcomes (11)
Pressure pain threshold on thigh
Algometer pressure (in kPa) for the pain threshold
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Unpleasantness of pressure pain threshold on thigh
Children rate their unpleasantness on a scale 0-10
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Conditioned pain modulation
Conditioned pain: hand in 10°C cold water, test pain: presseure pain thresholds by algometer on the participant's thigh. Difference in pressure pain thresholds with and without the simultaneous conditioned stimuli
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Temporal summation
Pinprick stimuli of low pain, one time, then repeated 10 times. Pain after repeated stimulus minus pain for the single stimulus.
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Sensory attenuation of pain
Pressure pain thresholds (kPa) applied by the child or the experimenter. Sensory attenuation = difference in pain threshold between self-induced and experimenter induced
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Resting state fMRI
Differences in network connectivity (Yeo networks + subcortical areas) and between seed (trunk in the somatosensory cortex) to Yeo brain networks + subcortical areas).
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
fMRI during low pain compared with non-painful tactile stimulus
Differences in network connectivity (Yeo networks + subcortical areas) and between seed (trunk in the somatosensory cortex) to Yeo brain networks + subcortical areas).
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Pediatric Quality of Life Inventory Gastrointestinal Symptom Scale (PedsQL Gastro)
Self-assessed questionnaire of abdominal symptoms
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Faces Pain Rating Scale (FACES)
Self-assessed questionnaire of pain intensity
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Visceral sensitivity Index, child-adapted short version (VSI-C)
Self-assessed questionnaire of gastrointestinal-specific anxiety
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Irritable bowel syndrome-behavioral responses questionnaire, child-adapted short version (BRQ-C)
Self-assessed questionnaire of gastrointestinal-specific avoidance and controlling behaviors
Measured: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Nov 2023
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Abdominal Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Child and Adolescent Psychiatry, Stockholm
- Responsible party
- Principal investigator, Maria Lalouni, Karolinska Institutet
- Investigators
- Maria Lalouni, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945251
- Sponsor's protocol ID
- 20223238
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Online Cognitive Behavioral Therapy for Children With Functional Abdominal Pain Disorders - the Child's Pain Regulation
- ClinicalTrials.gov ID
- NCT05945251
- Acronym / sponsor ID
- 20223238
- Conditions
- Functional Abdominal Pain Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Child and Adolescent Psychiatry, Stockholm
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 14 Jul 2023 (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 abdominal pain disorders (FAPDs) in children are common (14%) and abdominal pain has increased rapidly in children during the last ten years in Sweden. Many children with FAPDs have low quality of life, missed school days, and about 30-40% suffer from psychiatric comorbidity. FAPDs are often sustained into adulthood and a large Swedish cohort study showed that abdominal pain during childhood is an independent strong predictor anxiety and depression later in life. Internet-cognitive behavioral therapy (Internet-CBT) can improve FAPD symptoms, but a significant number of children does not respond to the treatment.
We will here determine the pain regulation in children with FAPDs, compared with healthy controls, and assess:
What aspects of the child's pain regulation is related to improvement for children with FAPDs engaging in Internet-CBT?
Does some aspects of the child's pain regulation change during treatment?
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAPDs | – | Other: Internet-delivered cognitive behavioral therapyChildren 8-17 years with FAPDs |
| Controls | – | –Children 8-17 years without FAPDs |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children (n=40) aged 8-17 with FAPDs who are patients at BUP Internetbehandling within the Child and Adolescent Psychiatry in Stockholm will be included in the study. Their behavioral and neural pain mechanisms will be assessed before and after Internet-CBT. We will also recruit healthy control children (n=40) aged 8-17 to compare the pain regulation between the groups. First, we will ask whether there are healthy siblings to the participating children with FAPDs that are willing to participate. If we don't get enough children by asking siblings, social media will be used in the recruitment.
Key inclusion criteria (2 listed)
- Children 8-17 years with FAPDs: Have been offered treatment at BUP Internetbehandling for FAPDs.
- Children 8-17 years without FAPDs: Not affected by recurrent (every week) or persistant pain during the last year.
Key exclusion criteria (1 listed)
- Contraindication for MR (metal implant or metal object in body, claustrophobia, pregnancy)
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 behavioral therapyTen weekly modules for children and ten weekly modules for parents. Exposure-based cognitive behavioral therapy delivered online with asynchronous support via text messages from psychologists. | Other | FAPDs |
Primary outcome
Pressure pain threshold on navel
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Algometer pressure (in kPa) for the pain threshold
Unpleasantness of pressure pain threshold on navel
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Children rate their unpleasantness on a scale 0-10
11 secondary outcomes
Pressure pain threshold on thigh
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Unpleasantness of pressure pain threshold on thigh
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Conditioned pain modulation
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Temporal summation
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Sensory attenuation of pain
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Resting state fMRI
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
fMRI during low pain compared with non-painful tactile stimulus
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Pediatric Quality of Life Inventory Gastrointestinal Symptom Scale (PedsQL Gastro)
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Faces Pain Rating Scale (FACES)
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Visceral sensitivity Index, child-adapted short version (VSI-C)
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Irritable bowel syndrome-behavioral responses questionnaire, child-adapted short version (BRQ-C)
Time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
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 9 Oct 2026.
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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.
Maria Lalouni, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Abdominal Pain Syndrome, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 1 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 9 Oct 2026. 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 Sweden. 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?
Pressure pain threshold on navel (time frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)). 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?
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 9 Oct 2026.