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 - 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
SN - 1551-7144
VL - 88
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 105898
ER -