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

NCT ID: NCT05945251

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-01-31

Brief Summary

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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?

Detailed Description

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Conditions

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Functional Abdominal Pain Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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FAPDs

Children 8-17 years with FAPDs

Internet-delivered cognitive behavioral therapy

Intervention Type 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.

Controls

Children 8-17 years without FAPDs

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Child and Adolescent Psychiatry, Stockholm

INDUSTRY

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Maria Lalouni

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Lalouni, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, Karolinska Institutet, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Maria Lalouni, PhD

Role: CONTACT

+46709473148

Viktor Vadenmark, MSc

Role: CONTACT

+46707220594

Facility Contacts

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Maria Lalouni, PhD

Role: primary

+46709473148

Viktor Vadenmark, MSc

Role: backup

+707220594

Other Identifiers

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20223238

Identifier Type: -

Identifier Source: org_study_id

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