Neural Mechanisms of Treatment Response to ADAPT (NCT03518216) | Clinical Trial Compass
CompletedNot Applicable
Neural Mechanisms of Treatment Response to ADAPT
United States49 participantsStarted 2018-07-03
Plain-language summary
Complex functional abdominal pain disorders (FAPD) with co-occurring anxiety are highly prevalent in children, can be very disabling, and are not responsive to currently available treatments. This research aims to better understand the neural mechanisms involved in a promising nonpharmacological treatment for FAPD to ultimately guide the development of more targeted treatment approaches for afflicted youth.
Who can participate
Age range11 Years – 16 Years
SexALL
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Inclusion Criteria
* Children (boys and girls) between 11 and 16 years of age and their parent/primary caregiver.
* Meets criteria for FAPD based on physician diagnosis of FAPD and ROME IV FAPD criteria
* Meets criteria for presence of clinically significant anxiety (based on the Generalized Anxiety Disorders-7 \[GAD-7\] cut-off score ≥10).
* Sufficient English language ability necessary to complete study measures and protocol.
Exclusion Criteria
* Children with significant medical condition(s) with an identifiable organic cause including those that may include abdominal pain symptoms (e.g., Inflammatory Bowel Diseases).
* Children with a documented developmental delays, autism spectrum disorder, a previously diagnosed thought disorder (i.e., psychosis), or bipolar disorder.
* Significant visual, hearing, or speech impairment.
* Organic brain injury.
* Participants who are currently in psychological therapy for pain or anxiety.
* Participants with severe depressive symptoms (cut-score ≥20) on the Patient Health Questionnaire 9 \[PHQ-9\] or active suicidal ideation.
* Exclusionary criteria specific to the fMRI component of the study:
* Participants with an implant such as a cochlear implant device, a pacemaker or neurostimulator containing electrical circuitry or generating magnetic signals. Participants with any significant ferrous material in their body that could pose the potential for harm in the fMRI environment or cause signal suppression of key regions (i.e. orthodon…
What they're measuring
1
Functional Connectivity of Amygdala with the Prefrontal Cortex
Timeframe: through study completion, an average of 9 weeks