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NCT Number: NCT05945251

ICBT for Children With FAPDs - 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?

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Key information

Conditions

Functional Abdominal Pain Syndrome

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Internet-delivered cognitive behavioral therapy

Other

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.

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Lalouni, PhD

CONTACT

[email protected]

+46709473148

Viktor Vadenmark, MSc

CONTACT

[email protected]

+46707220594

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Child and Adolescent Psychiatry, Stockholm

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2023
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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