Web-based cognitive-behavioral intervention for pain in pediatric acute recurrent and chronic pancreatitis: Protocol of a multicenter randomized controlled trial from the study of chronic pancreatitis, diabetes and pancreatic cancer (CPDPC)
Tonya M Palermo, Caitlin Murray, Homer Aalfs, Maisam Abu-El-Haija, Bradley Barth, Melena D Bellin, Kate Ellery, Douglas S Fishman, Cheryl E Gariepy, Matthew J Giefer, Praveen Goday, Tanja Gonska, Melvin B Heyman, Sohail Z Husain, Tom K Lin, Quin Y Liu, Maria R Mascarenhas, Asim Maqbool, Brian McFerron, Veronique D Morinville, Jaimie D Nathan, Chee Y Ooi, Emily R Perito, John F Pohl, Sarah Jane Schwarzenberg, Zachary M Sellers, Jose Serrano, Uzma Shah, David Troendle, Yuhua Zheng, Ying Yuan, Mark Lowe, Aliye Uc, Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer, Tonya M Palermo, Caitlin Murray, Homer Aalfs, Maisam Abu-El-Haija, Bradley Barth, Melena D Bellin, Kate Ellery, Douglas S Fishman, Cheryl E Gariepy, Matthew J Giefer, Praveen Goday, Tanja Gonska, Melvin B Heyman, Sohail Z Husain, Tom K Lin, Quin Y Liu, Maria R Mascarenhas, Asim Maqbool, Brian McFerron, Veronique D Morinville, Jaimie D Nathan, Chee Y Ooi, Emily R Perito, John F Pohl, Sarah Jane Schwarzenberg, Zachary M Sellers, Jose Serrano, Uzma Shah, David Troendle, Yuhua Zheng, Ying Yuan, Mark Lowe, Aliye Uc, Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer
Abstract
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.
Keywords: Acute recurrent pancreatitis; Children; Chronic pancreatitis; Cognitive-behavioral therapy; Internet intervention; Pain.
Copyright © 2019 Elsevier Inc. All rights reserved.
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Source: PubMed