Clinical trial NCT05945251: ICBT for Children With FAPDs - the Child's Pain Regulation
Official title: Individualized Online Cognitive Behavioral Therapy for Children With Functional Abdominal Pain Disorders - the Child's Pain Regulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Functional Abdominal Pain Syndrome
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Child and Adolescent Psychiatry, Stockholm
First posted: 2023-07-14
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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?


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)

Primary outcomes:
measure: Pressure pain threshold on navel
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
measure: Unpleasantness of pressure pain threshold on navel
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Secondary outcomes:
measure: Pressure pain threshold on thigh
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
measure: Unpleasantness of pressure pain threshold on thigh
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
measure: Conditioned pain modulation
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
measure: Temporal summation
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
measure: Sensory attenuation of pain
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
measure: Resting state fMRI
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
measure: fMRI during low pain compared with non-painful tactile stimulus
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
measure: Pediatric Quality of Life Inventory Gastrointestinal Symptom Scale (PedsQL Gastro)
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
measure: Faces Pain Rating Scale (FACES)
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
measure: Visceral sensitivity Index, child-adapted short version (VSI-C)
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
measure: Irritable bowel syndrome-behavioral responses questionnaire, child-adapted short version (BRQ-C)
timeFrame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Maria Lalouni, PhD
role: PRINCIPAL_INVESTIGATOR
References: