TY - JOUR
T1 - Web-based cognitive-behavioral intervention for pain in pediatric acute recurrent and chronic pancreatitis
T2 - Protocol of a multicenter randomized controlled trial from the study of chronic pancreatitis, diabetes and pancreatic cancer (CPDPC)
AU - on behalf of the Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer
AU - Palermo, Tonya M.
AU - Murray, Caitlin
AU - Aalfs, Homer
AU - Abu-El-Haija, Maisam
AU - Barth, Bradley
AU - Bellin, Melena D.
AU - Ellery, Kate
AU - Fishman, Douglas S.
AU - Gariepy, Cheryl E.
AU - Giefer, Matthew J.
AU - Goday, Praveen
AU - Gonska, Tanja
AU - Heyman, Melvin B.
AU - Husain, Sohail Z.
AU - Lin, Tom K.
AU - Liu, Quin Y.
AU - Mascarenhas, Maria R.
AU - Maqbool, Asim
AU - McFerron, Brian
AU - Morinville, Veronique D.
AU - Nathan, Jaimie D.
AU - Ooi, Chee Y.
AU - Perito, Emily R.
AU - Pohl, John F.
AU - Schwarzenberg, Sarah Jane
AU - Sellers, Zachary M.
AU - Serrano, Jose
AU - Shah, Uzma
AU - Troendle, David
AU - Zheng, Yuhua
AU - Yuan, Ying
AU - Lowe, Mark
AU - Uc, Aliye
N1 - Funding Information:
Research reported in this publication was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Award Number R01DK118752 and U01 DK108334. The INSPPIRE (INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers, are supported by NIDDK Award number U01DK108334. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Funding Information:
Research reported in this publication was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Award Number R01DK118752 and U01 DK108334 . The INSPPIRE ( IN ternational S tudy Group of P ediatric P ancreatitis: I n search for a cu RE) centers, are supported by NIDDK Award number U01DK108334 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2020/1
Y1 - 2020/1
N2 - Introduction: Abdominal pain is common and is associated with high disease burden and health care costs in pediatric acute recurrent and chronic pancreatitis (ARP/CP). Despite the strong central component of pain in ARP/CP and the efficacy of psychological therapies for other centralized pain syndromes, no studies have evaluated psychological pain interventions in children with ARP/CP. The current trial seeks to 1) evaluate the efficacy of a psychological pain intervention for pediatric ARP/CP, and 2) examine baseline patient-specific genetic, clinical, and psychosocial characteristics that may predict or moderate treatment response. Methods: This single-blinded randomized placebo-controlled multicenter trial aims to enroll 260 youth (ages 10–18) with ARP/CP and their parents from twenty-one INSPPIRE (INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers. Participants will be randomly assigned to either a web-based cognitive behavioral pain management intervention (Web-based Management of Adolescent Pain Chronic Pancreatitis; WebMAP; N = 130) or to a web-based pain education program (WebED; N = 130). Assessments will be completed at baseline (T1), immediately after completion of the intervention (T2) and at 6 months post-intervention (T3). The primary study outcome is abdominal pain severity. Secondary outcomes include pain-related disability, pain interference, health-related quality of life, emotional distress, impact of pain, opioid use, and healthcare utilization. Conclusions: This is the first clinical trial to evaluate the efficacy of a psychological pain intervention for children with CP for reduction of abdominal pain and improvement of health-related quality of life. Findings will inform delivery of web-based pain management and potentially identify patient-specific biological and psychosocial factors associated with favorable response to therapy. Clinical Trial Registration #: NCT03707431.
AB - Introduction: Abdominal pain is common and is associated with high disease burden and health care costs in pediatric acute recurrent and chronic pancreatitis (ARP/CP). Despite the strong central component of pain in ARP/CP and the efficacy of psychological therapies for other centralized pain syndromes, no studies have evaluated psychological pain interventions in children with ARP/CP. The current trial seeks to 1) evaluate the efficacy of a psychological pain intervention for pediatric ARP/CP, and 2) examine baseline patient-specific genetic, clinical, and psychosocial characteristics that may predict or moderate treatment response. Methods: This single-blinded randomized placebo-controlled multicenter trial aims to enroll 260 youth (ages 10–18) with ARP/CP and their parents from twenty-one INSPPIRE (INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers. Participants will be randomly assigned to either a web-based cognitive behavioral pain management intervention (Web-based Management of Adolescent Pain Chronic Pancreatitis; WebMAP; N = 130) or to a web-based pain education program (WebED; N = 130). Assessments will be completed at baseline (T1), immediately after completion of the intervention (T2) and at 6 months post-intervention (T3). The primary study outcome is abdominal pain severity. Secondary outcomes include pain-related disability, pain interference, health-related quality of life, emotional distress, impact of pain, opioid use, and healthcare utilization. Conclusions: This is the first clinical trial to evaluate the efficacy of a psychological pain intervention for children with CP for reduction of abdominal pain and improvement of health-related quality of life. Findings will inform delivery of web-based pain management and potentially identify patient-specific biological and psychosocial factors associated with favorable response to therapy. Clinical Trial Registration #: NCT03707431.
KW - Acute recurrent pancreatitis
KW - Children
KW - Chronic pancreatitis
KW - Cognitive-behavioral therapy
KW - Internet intervention
KW - Pain
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UR - http://www.scopus.com/inward/citedby.url?scp=85075535488&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2019.105898
DO - 10.1016/j.cct.2019.105898
M3 - Article
C2 - 31756383
AN - SCOPUS:85075535488
VL - 88
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
M1 - 105898
ER -