ICBT for Children With FAPDs - the Child's Pain Regulation
ConditionFunctional Abdominal Pain Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-17
SponsorKarolinska Institutet
About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Children (n=40) aged 8-17 with FAPDs who are patients at BUP Internetbehandling within the Child and Adolescent Psychiatry in Stockholm will be included in the study. Their behavioral and neural pain mechanisms will be assessed before and after Internet-CBT. We will also recruit healthy control children (n=40) aged 8-17 to compare the pain regulation between the groups. First, we will ask whether there are healthy siblings to the participating children with FAPDs that are willing to participate. If we don't get enough children by asking siblings, social media will be used in the recruitment.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Internet-delivered cognitive behavioral therapy
Other interventionTen 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: FAPDs1 intervention
Group B: Controls0 interventions
Trial outcomes
Primary outcomes
1
Pressure pain threshold on navel
Algometer pressure (in kPa) for the pain threshold
Time frame
Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)2
Unpleasantness of pressure pain threshold on navel
Children rate their unpleasantness on a scale 0-10
Time frame
Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)Secondary outcomes
1
Pressure pain threshold on thigh
Algometer pressure (in kPa) for the pain threshold
Time frame
Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)2
Unpleasantness of pressure pain threshold on thigh
Children rate their unpleasantness on a scale 0-10
Time frame
Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)3
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
Time frame
Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)4
Temporal summation
Pinprick stimuli of low pain, one time, then repeated 10 times. Pain after repeated stimulus minus pain for the single stimulus.
Time frame
Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Child and Adolescent Psychiatry, Stockholm
Collaborator
Source ClinicalTrials.gov