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ICBT for Children With FAPDs - the Child's Pain Regulation

Individualized Online Cognitive Behavioral Therapy for Children With Functional Abdominal Pain Disorders - the Child's Pain Regulation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05945251
Enrollment
80
Registered
2023-07-14
Start date
2023-11-01
Completion date
2026-09-01
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Abdominal Pain Syndrome

Brief 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. 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?

Interventions

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.

Sponsors

Karolinska Institutet
Lead SponsorOTHER
Child and Adolescent Psychiatry, Stockholm
CollaboratorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

Contraindication for MR (metal implant or metal object in body, claustrophobia, pregnancy)

Design outcomes

Primary

MeasureTime frameDescription
Pressure pain threshold on navelBaseline 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 navelBaseline 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

Secondary

MeasureTime frameDescription
Pressure pain threshold on thighBaseline 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 thighBaseline 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
Conditioned pain modulationBaseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)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
Temporal summationBaseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)Pinprick stimuli of low pain, one time, then repeated 10 times. Pain after repeated stimulus minus pain for the single stimulus.
Sensory attenuation of painBaseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)Pressure pain thresholds (kPa) applied by the child or the experimenter. Sensory attenuation = difference in pain threshold between self-induced and experimenter induced
Resting state fMRIBaseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)Differences in network connectivity (Yeo networks + subcortical areas) and between seed (trunk in the somatosensory cortex) to Yeo brain networks + subcortical areas).
fMRI during low pain compared with non-painful tactile stimulusBaseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)Differences in network connectivity (Yeo networks + subcortical areas) and between seed (trunk in the somatosensory cortex) to Yeo brain networks + subcortical areas).
Pediatric Quality of Life Inventory Gastrointestinal Symptom Scale (PedsQL Gastro)Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)Self-assessed questionnaire of abdominal symptoms
Faces Pain Rating Scale (FACES)Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)Self-assessed questionnaire of pain intensity
Visceral sensitivity Index, child-adapted short version (VSI-C)Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)Self-assessed questionnaire of gastrointestinal-specific anxiety
Irritable bowel syndrome-behavioral responses questionnaire, child-adapted short version (BRQ-C)Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)Self-assessed questionnaire of gastrointestinal-specific avoidance and controlling behaviors

Countries

Sweden

Contacts

PRINCIPAL_INVESTIGATORMaria Lalouni, PhD

Karolinska Institutet

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026