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

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ClinicalTrials.gov Identifier: NCT05945251
Recruitment Status : Recruiting
First Posted : July 14, 2023
Last Update Posted : March 5, 2024
Sponsor:
Collaborator:
Child and Adolescent Psychiatry, Stockholm
Information provided by (Responsible Party):
Maria Lalouni, Karolinska Institutet

Study Description
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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?


Condition or disease Intervention/treatment
Functional Abdominal Pain Syndrome Other: Internet-delivered cognitive behavioral therapy

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Individualized Online Cognitive Behavioral Therapy for Children With Functional Abdominal Pain Disorders - the Child's Pain Regulation
Actual Study Start Date : November 1, 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pressure pain threshold on navel [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    Algometer pressure (in kPa) for the pain threshold

  2. Unpleasantness of pressure pain threshold on navel [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    Children rate their unpleasantness on a scale 0-10


Secondary Outcome Measures :
  1. Pressure pain threshold on thigh [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    Algometer pressure (in kPa) for the pain threshold

  2. Unpleasantness of pressure pain threshold on thigh [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    Children rate their unpleasantness on a scale 0-10

  3. Conditioned pain modulation [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    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

  4. Temporal summation [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    Pinprick stimuli of low pain, one time, then repeated 10 times. Pain after repeated stimulus minus pain for the single stimulus.

  5. Sensory attenuation of pain [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    Pressure pain thresholds (kPa) applied by the child or the experimenter. Sensory attenuation = difference in pain threshold between self-induced and experimenter induced

  6. Resting state fMRI [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    Differences in network connectivity (Yeo networks + subcortical areas) and between seed (trunk in the somatosensory cortex) to Yeo brain networks + subcortical areas).

  7. fMRI during low pain compared with non-painful tactile stimulus [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    Differences in network connectivity (Yeo networks + subcortical areas) and between seed (trunk in the somatosensory cortex) to Yeo brain networks + subcortical areas).

  8. Pediatric Quality of Life Inventory Gastrointestinal Symptom Scale (PedsQL Gastro) [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    Self-assessed questionnaire of abdominal symptoms

  9. Faces Pain Rating Scale (FACES) [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    Self-assessed questionnaire of pain intensity

  10. Visceral sensitivity Index, child-adapted short version (VSI-C) [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    Self-assessed questionnaire of gastrointestinal-specific anxiety

  11. Irritable bowel syndrome-behavioral responses questionnaire, child-adapted short version (BRQ-C) [ Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children) ]
    Self-assessed questionnaire of gastrointestinal-specific avoidance and controlling behaviors


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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.
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)

Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05945251


Contacts
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Contact: Maria Lalouni, PhD +46709473148 maria.lalouni@ki.se
Contact: Viktor Vadenmark, MSc +46707220594 viktor.vadenmarklundqvist@ki.se

Locations
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Sweden
Karolinska Institutet Recruiting
Stockholm, Karolinska Institutet, Sweden, 17177
Contact: Maria Lalouni, PhD    +46709473148    maria.lalouni@ki.se   
Contact: Viktor Vadenmark, MSc    +707220594    viktor.vadenmark.lundqvist@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Child and Adolescent Psychiatry, Stockholm
Investigators
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Principal Investigator: Maria Lalouni, PhD Karolinska Institutet
More Information
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Responsible Party: Maria Lalouni, Assistant Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT05945251    
Other Study ID Numbers: 20223238
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: March 5, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive