Back to Search Start Over

Study protocol for a pilot clinical trial to understand neural mechanisms of response to a psychological treatment for pain and anxiety in pediatric functional abdominal pain disorders (FAPD).

Authors :
Natoshia R Cunningham
Michelle A Adler
Brittany N Barber Garcia
Taylor Abounader
Alaina K Miller
Mariela Monzalvo
Ismaeel Hashemi
Ryan Cox
Samantha L Ely
Yong Zhou
Mark DeLano
Todd Mulderink
Mathew J Reeves
James L Peugh
Susmita Kashikar-Zuck
Robert C Coghill
Judith E Arnetz
David C Zhu
Source :
PLoS ONE, Vol 19, Iss 3, p e0299170 (2024)
Publication Year :
2024
Publisher :
Public Library of Science (PLoS), 2024.

Abstract

BackgroundFunctional abdominal pain disorders (FAPD) are the most common chronic pain conditions of childhood and are made worse by co-occurring anxiety. Our research team found that the Aim to Decrease Pain and Anxiety Treatment (ADAPT), a six-session coping skills program using cognitive behavioral therapy strategies, was effective in improving pain-related symptoms and anxiety symptoms compared to standard care. In follow-up, this current randomized clinical trial (RCT) aims to test potential neural mechanisms underlying the effect of ADAPT. Specifically, this two-arm RCT will explore changes in amygdalar functional connectivity (primary outcome) following the ADAPT protocol during the water loading symptom provocation task (WL-SPT). Secondary (e.g., changes in regional cerebral blood flow via pulsed arterial spin labeling MRI) and exploratory (e.g., the association between the changes in functional connectivity and clinical symptoms) outcomes will also be investigated.MethodsWe will include patients ages 11 to 16 years presenting to outpatient pediatric gastroenterology care at a midwestern children's hospital with a diagnosis of FAPD plus evidence of clinical anxiety based on a validated screening tool (the Generalized Anxiety Disorder-7 [GAD-7] measure). Eligible participants will undergo baseline neuroimaging involving the WL-SPT, and assessment of self-reported pain, anxiety, and additional symptoms, prior to being randomized to a six-week remotely delivered ADAPT program plus standard medical care or standard medical care alone (waitlist). Thereafter, subjects will complete a post assessment neuroimaging visit similar in nature to their first visit.ConclusionsThis small scale RCT aims to increase understanding of potential neural mechanisms of response to ADAPT.Trial registrationClinicalTrials.gov registration: NCT03518216.

Subjects

Subjects :
Medicine
Science

Details

Language :
English
ISSN :
19326203
Volume :
19
Issue :
3
Database :
Directory of Open Access Journals
Journal :
PLoS ONE
Publication Type :
Academic Journal
Accession number :
edsdoj.386ec5f01758431eb52c15599aad44ec
Document Type :
article
Full Text :
https://doi.org/10.1371/journal.pone.0299170&type=printable