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)
Copyright: © 2024 Cunningham et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited..
BACKGROUND: Functional 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.
METHODS: We 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.
CONCLUSIONS: This small scale RCT aims to increase understanding of potential neural mechanisms of response to ADAPT.
TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT03518216.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:19 |
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| Enthalten in: |
PloS one - 19(2024), 3 vom: 28., Seite e0299170 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Cunningham, Natoshia R [VerfasserIn] |
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| Anmerkungen: |
Date Completed 20.03.2024 Date Revised 01.04.2024 published: Electronic-eCollection ClinicalTrials.gov: NCT03518216 Citation Status MEDLINE |
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| doi: |
10.1371/journal.pone.0299170 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM369882695 |
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| 245 | 1 | 0 | |a 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) |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright: © 2024 Cunningham et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. | ||
| 520 | |a BACKGROUND: Functional 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 | ||
| 520 | |a METHODS: We 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 | ||
| 520 | |a CONCLUSIONS: This small scale RCT aims to increase understanding of potential neural mechanisms of response to ADAPT | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT03518216 | ||
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| 700 | 1 | |a Barber Garcia, Brittany N |e verfasserin |4 aut | |
| 700 | 1 | |a Abounader, Taylor |e verfasserin |4 aut | |
| 700 | 1 | |a Miller, Alaina K |e verfasserin |4 aut | |
| 700 | 1 | |a Monzalvo, Mariela |e verfasserin |4 aut | |
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| 700 | 1 | |a Cox, Ryan |e verfasserin |4 aut | |
| 700 | 1 | |a Ely, Samantha L |e verfasserin |4 aut | |
| 700 | 1 | |a Zhou, Yong |e verfasserin |4 aut | |
| 700 | 1 | |a DeLano, Mark |e verfasserin |4 aut | |
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| 700 | 1 | |a Arnetz, Judith E |e verfasserin |4 aut | |
| 700 | 1 | |a Zhu, David C |e verfasserin |4 aut | |
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