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

NCT05945251 | Recruiting

• 1 other identifier: 20223238
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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?

Conditions

Functional Abdominal Pain Syndrome

Outcome Measures

Primary Outcomes (2)

• Pressure pain threshold on navel

  Algometer pressure (in kPa) for the pain threshold

  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

  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

  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

  Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)

• Conditioned pain modulation

  Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)

• Temporal summation

  Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)

• Sensory attenuation of pain

  Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)

Study Arms (2)

FAPDs

Children 8-17 years with FAPDs

Other: Internet-delivered cognitive behavioral therapy

Controls

Children 8-17 years without FAPDs

Interventions

Internet-delivered cognitive behavioral therapy OTHER

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.

FAPDs

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Child and Adolescent Psychiatry, Stockholm: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Karolinska Institutet, 17177, Sweden

RECRUITING

Study Officials

• Maria Lalouni, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Lalouni, PhD

CONTACT

+46709473148; maria.lalouni@ki.se

Viktor Vadenmark, MSc

CONTACT

+46707220594; viktor.vadenmarklundqvist@ki.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

SE (1)