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Recruiting NCT05945251

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

— Observational Functional Abdominal Pain Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Internet-delivered cognitive behavioral therapy.
Who it may be relevant to
Registry conditions: Functional Abdominal Pain Syndrome. Basic parameters: 8 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Internet-delivered cognitive behavioral therapy
    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.

Primary outcome measures

  • 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)]
  • 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)]
Secondary outcome measures (11)
  • 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Sweden · 1 center
  • Karolinska Institutet — Stockholm

Identifiers

NCT: NCT05945251 · 20223238

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗