Neural Mechanisms of Treatment Response to ADAPT
Completed · Not applicable
Conditions studied: Functional Abdominal Pain Syndrome, Anxiety
In brief
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.
Key facts
- Study ID
- NCT03518216
- Run by
- Michigan State University
- People needed
- 49
- Starts
- 2018-07-03
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2025-10-30
Who can join
Age: 11 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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. orthodontia).
- Female participants who report current/suspected pregnancy.
- Participants with evidence of claustrophobia.
Where it is running
- Michigan State University — Grand Rapids, Michigan, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.