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

Study Overview
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Brief Summary
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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?

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

Conditions
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Functional Abdominal Pain Syndrome

Intervention / Treatment
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* Other: Internet-delivered cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FAPDs<br>Children 8-17 years with FAPDs | Other: Internet-delivered cognitive behavioral therapy<br>* 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.<br>|
| Controls<br>Children 8-17 years without FAPDs | |

What is the study measuring?
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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) |