ICBT for Children With FAPDs - the Child's Pain Regulation
- Conditions
- Functional Abdominal Pain Syndrome
- Interventions
- Other: Internet-delivered cognitive behavioral therapy
- Registration Number
- NCT05945251
- Lead Sponsor
- Karolinska Institutet
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
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.
Contraindication for MR (metal implant or metal object in body, claustrophobia, pregnancy)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description FAPDs Internet-delivered cognitive behavioral therapy Children 8-17 years with FAPDs
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method 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
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
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
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
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
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.
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).
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
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
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
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).
Trial Locations
- Locations (1)
Karolinska Institutet
🇸🇪Stockholm, Karolinska Institutet, Sweden