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

Functional Abdominal Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945251
• Other study ID #: 20223238
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Maria Lalouni, PhD
• Phone: +46709473148
• Email: maria.lalouni[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Pain
• Functional Abdominal Pain Syndrome

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm	Karolinska Institutet

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Child and Adolescent Psychiatry, Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

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