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

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

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?

Study Overview

• Status: Recruiting
• Conditions: Functional Abdominal Pain Syndrome
• Intervention / Treatment: Other: Internet-delivered cognitive behavioral therapy

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Maria Lalouni, PhD; Phone Number: +46709473148; Email: maria.lalouni@ki.se
• Study Contact Backup: Name: Viktor Vadenmark, MSc; Phone Number: +46707220594; Email: viktor.vadenmarklundqvist@ki.se

Study Locations

• Sweden
  • Karolinska Institutet
    • Stockholm, Karolinska Institutet, Sweden, 17177
      • Recruiting
      • Karolinska Institutet
      • Contact: Maria Lalouni, PhD; Phone Number: +46709473148; Email: maria.lalouni@ki.se
      • Contact: Viktor Vadenmark, MSc; Phone Number: +707220594; Email: viktor.vadenmark.lundqvist@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FAPDs; Children 8-17 years with FAPDs	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.
Controls; Children 8-17 years without FAPDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Child and Adolescent Psychiatry, Stockholm
• Investigators: Principal Investigator: Maria Lalouni, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: 20223238

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No