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) Article Swipe
Natoshia R. Cunningham
,
Michelle Adler
,
Brittany N. Barber Garcia
,
Taylor Abounader
,
Alaina K. Miller
,
Mariela Monzalvo
,
Ismaeel Hashemi
,
Ryan Cox
,
Samantha Ely
,
Zhou Yong
,
Mark C. DeLano
,
Todd Mulderink
,
Mathew J. Reeves
,
James Peugh
,
Susmita Kashikar‐Zuck
,
Robert C. Coghill
,
Judith E. Arnetz
,
David C. Zhu
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1371/journal.pone.0299170
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1371/journal.pone.0299170
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 .
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1371/journal.pone.0299170
- https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0299170&type=printable
- OA Status
- gold
- Cited By
- 1
- References
- 75
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4392906181
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Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4392906181Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1371/journal.pone.0299170Digital Object Identifier
- Title
-
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)Work title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-03-18Full publication date if available
- Authors
-
Natoshia R. Cunningham, Michelle Adler, Brittany N. Barber Garcia, Taylor Abounader, Alaina K. Miller, Mariela Monzalvo, Ismaeel Hashemi, Ryan Cox, Samantha Ely, Zhou Yong, Mark C. DeLano, Todd Mulderink, Mathew J. Reeves, James Peugh, Susmita Kashikar‐Zuck, Robert C. Coghill, Judith E. Arnetz, David C. ZhuList of authors in order
- Landing page
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https://doi.org/10.1371/journal.pone.0299170Publisher landing page
- PDF URL
-
https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0299170&type=printableDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0299170&type=printableDirect OA link when available
- Concepts
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Anxiety, Randomized controlled trial, Medicine, Physical therapy, Cognitive behavioral therapy, Abdominal pain, Clinical trial, Neuroimaging, Psychiatry, Internal medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
1Total citation count in OpenAlex
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2025: 1Per-year citation counts (last 5 years)
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75Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.loading | 98 |
| abstract_inverted_index.medical | 210, 214 |
| abstract_inverted_index.program | 40, 207 |
| abstract_inverted_index.similar | 227 |
| abstract_inverted_index.symptom | 99 |
| abstract_inverted_index.therapy | 44 |
| abstract_inverted_index.two-arm | 80 |
| abstract_inverted_index.undergo | 182 |
| abstract_inverted_index.(ADAPT), | 35 |
| abstract_inverted_index.(primary | 89 |
| abstract_inverted_index.Decrease | 30 |
| abstract_inverted_index.Eligible | 179 |
| abstract_inverted_index.anxiety, | 193 |
| abstract_inverted_index.anxiety. | 21 |
| abstract_inverted_index.arterial | 113 |
| abstract_inverted_index.baseline | 183 |
| abstract_inverted_index.cerebral | 108 |
| abstract_inverted_index.clinical | 64, 129, 165 |
| abstract_inverted_index.compared | 55 |
| abstract_inverted_index.complete | 221 |
| abstract_inverted_index.evidence | 163 |
| abstract_inverted_index.hospital | 156 |
| abstract_inverted_index.increase | 241 |
| abstract_inverted_index.labeling | 115 |
| abstract_inverted_index.outcome) | 90 |
| abstract_inverted_index.outcomes | 131 |
| abstract_inverted_index.patients | 140 |
| abstract_inverted_index.protocol | 94 |
| abstract_inverted_index.regional | 107 |
| abstract_inverted_index.remotely | 204 |
| abstract_inverted_index.research | 23 |
| abstract_inverted_index.response | 248 |
| abstract_inverted_index.six-week | 203 |
| abstract_inverted_index.standard | 57, 209, 213 |
| abstract_inverted_index.subjects | 219 |
| abstract_inverted_index.symptoms | 51, 54 |
| abstract_inverted_index.(WL-SPT). | 102 |
| abstract_inverted_index.Secondary | 103 |
| abstract_inverted_index.Treatment | 34 |
| abstract_inverted_index.abdominal | 2 |
| abstract_inverted_index.amygdalar | 86 |
| abstract_inverted_index.childhood | 14 |
| abstract_inverted_index.cognitive | 42 |
| abstract_inverted_index.delivered | 205 |
| abstract_inverted_index.diagnosis | 159 |
| abstract_inverted_index.disorders | 4 |
| abstract_inverted_index.effective | 47 |
| abstract_inverted_index.following | 91 |
| abstract_inverted_index.improving | 49 |
| abstract_inverted_index.involving | 185 |
| abstract_inverted_index.measure). | 178 |
| abstract_inverted_index.pediatric | 149 |
| abstract_inverted_index.potential | 70, 244 |
| abstract_inverted_index.screening | 171 |
| abstract_inverted_index.symptoms) | 130 |
| abstract_inverted_index.symptoms, | 196 |
| abstract_inverted_index.validated | 170 |
| abstract_inverted_index.Background | 0 |
| abstract_inverted_index.Disorder-7 | 176 |
| abstract_inverted_index.Functional | 1 |
| abstract_inverted_index.additional | 195 |
| abstract_inverted_index.assessment | 189, 224 |
| abstract_inverted_index.behavioral | 43 |
| abstract_inverted_index.conditions | 12 |
| abstract_inverted_index.follow-up, | 60 |
| abstract_inverted_index.functional | 87, 126 |
| abstract_inverted_index.mechanisms | 72, 246 |
| abstract_inverted_index.midwestern | 154 |
| abstract_inverted_index.outpatient | 148 |
| abstract_inverted_index.presenting | 146 |
| abstract_inverted_index.randomized | 63, 200 |
| abstract_inverted_index.underlying | 73 |
| abstract_inverted_index.(waitlist). | 217 |
| abstract_inverted_index.Conclusions | 234 |
| abstract_inverted_index.Generalized | 174 |
| abstract_inverted_index.NCT03518216 | 255 |
| abstract_inverted_index.Thereafter, | 218 |
| abstract_inverted_index.association | 121 |
| abstract_inverted_index.exploratory | 118 |
| abstract_inverted_index.provocation | 100 |
| abstract_inverted_index.six-session | 37 |
| abstract_inverted_index.strategies, | 45 |
| abstract_inverted_index.children’s | 155 |
| abstract_inverted_index.co-occurring | 20 |
| abstract_inverted_index.connectivity | 88, 127 |
| abstract_inverted_index.neuroimaging | 184, 225 |
| abstract_inverted_index.pain-related | 50 |
| abstract_inverted_index.participants | 180 |
| abstract_inverted_index.registration | 252 |
| abstract_inverted_index.Specifically, | 78 |
| abstract_inverted_index.investigated. | 135 |
| abstract_inverted_index.registration: | 254 |
| abstract_inverted_index.self-reported | 191 |
| abstract_inverted_index.understanding | 242 |
| abstract_inverted_index.gastroenterology | 150 |
| abstract_inverted_index.ClinicalTrials.gov | 253 |
| cited_by_percentile_year.max | 95 |
| cited_by_percentile_year.min | 91 |
| corresponding_author_ids | https://openalex.org/A5103048053, https://openalex.org/A5011184717, https://openalex.org/A5024870668, https://openalex.org/A5045680603, https://openalex.org/A5038719267, https://openalex.org/A5044462462, https://openalex.org/A5085793990, https://openalex.org/A5103224460, https://openalex.org/A5035384677, https://openalex.org/A5093899983, https://openalex.org/A5111149038, https://openalex.org/A5085108165, https://openalex.org/A5049977124, https://openalex.org/A5046565650, https://openalex.org/A5049634244, https://openalex.org/A5001379461, https://openalex.org/A5069084089, https://openalex.org/A5003389058 |
| countries_distinct_count | 1 |
| institutions_distinct_count | 18 |
| corresponding_institution_ids | https://openalex.org/I113026633, https://openalex.org/I1285204247, https://openalex.org/I185443292, https://openalex.org/I19648265, https://openalex.org/I2802152183, https://openalex.org/I4210111179, https://openalex.org/I4210130567, https://openalex.org/I4392738273, https://openalex.org/I87216513, https://openalex.org/I92156820 |
| citation_normalized_percentile.value | 0.8000386 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |