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

Sponsor
Karolinska Institutet (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05945251
Collaborator
Child and Adolescent Psychiatry, Stockholm (Industry)
80
24

Study Details

Study Description

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 Phase
  • Other: Internet-delivered cognitive behavioral therapy

Study Design

Study Type:
Observational
Anticipated 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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Pressure pain threshold on navel [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 [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 [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 [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 [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 [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 [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 [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 [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) [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) [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) [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) [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

Criteria

Ages Eligible for Study:
8 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

No locations specified.

Sponsors and Collaborators

  • Karolinska Institutet
  • Child and Adolescent Psychiatry, Stockholm

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Lalouni, Assistant Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT05945251
Other Study ID Numbers:
  • 20223238
First Posted:
Jul 14, 2023
Last Update Posted:
Jul 14, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2023