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

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed
    • Enrollment target: estimated 80 to confirmed 84
    • Primary and study completion dates changed from estimate of Sep 2026 to Sep 1, 2026
    • Secondary endpoints: details revised at 11 of 11 entries
  2. Primary and study completion pushed from Jan 2026 to Sep 2026
    • Enrollment closed, study ongoing
    • Site details revised
    v4
  3. Primary and study completion dates: Sep 2025 to Jan 2026v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2023 to Nov 1, 2023
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT05945251
Lead Sponsor Karolinska Institutet
Collaborators: Child and Adolescent Psychiatry, Stockholm
Conditions
(from sponsor)		 Functional Abdominal Pain Syndrome
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov