Individualized Online Cognitive Behavioral Therapy for Children With Functional Abdominal Pain Disorders - the Child's Pain Regulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Unpleasantness of pressure pain threshold on navel
Study Overview
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?
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 8 Years to 17 Years (Child)
- Sex
- 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)
Arms & Interventions
FAPDs
Children 8-17 years with FAPDs
Intervention: Internet-delivered cognitive behavioral therapy (Other)
Controls
Children 8-17 years without FAPDs
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- 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))
- Conditioned pain modulation(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)(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(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Sensory attenuation of pain(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)(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Temporal summation(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Resting state fMRI(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)(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)(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- 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))
Investigators
Maria Lalouni
Assistant Professor
Karolinska Institutet