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)
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 studie...
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| Veröffentlicht in: | Contemporary clinical trials 2020-01, Vol.88, p.105898-105898, Article 105898 |
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| creator | Palermo, Tonya M. Murray, Caitlin Aalfs, Homer Abu-El-Haija, Maisam Barth, Bradley Bellin, Melena D. Ellery, Kate Fishman, Douglas S. Gariepy, Cheryl E. Giefer, Matthew J. Goday, Praveen Gonska, Tanja Heyman, Melvin B. Husain, Sohail Z. Lin, Tom K. Liu, Quin Y. Mascarenhas, Maria R. Maqbool, Asim McFerron, Brian Morinville, Veronique D. Nathan, Jaimie D. Ooi, Chee Y. Perito, Emily R. Pohl, John F. Schwarzenberg, Sarah Jane Sellers, Zachary M. Serrano, Jose Shah, Uzma Troendle, David Zheng, Yuhua Yuan, Ying Lowe, Mark Uc, Aliye |
| description | 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.
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.
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. |
| doi_str_mv | 10.1016/j.cct.2019.105898 |
| format | Article |
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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.
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.</description><identifier>ISSN: 1551-7144</identifier><identifier>EISSN: 1559-2030</identifier><identifier>DOI: 10.1016/j.cct.2019.105898</identifier><identifier>PMID: 31756383</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Acute recurrent pancreatitis ; Children ; Chronic pancreatitis ; Cognitive-behavioral therapy ; Internet intervention ; Pain</subject><ispartof>Contemporary clinical trials, 2020-01, Vol.88, p.105898-105898, Article 105898</ispartof><rights>2019 Elsevier Inc.</rights><rights>Copyright © 2019 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c451t-ac25034833c55f217acbb34a73dc38cc1de3c1f43a88c8eec838ae745a6af3323</citedby><cites>FETCH-LOGICAL-c451t-ac25034833c55f217acbb34a73dc38cc1de3c1f43a88c8eec838ae745a6af3323</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1551714419306135$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31756383$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Palermo, Tonya M.</creatorcontrib><creatorcontrib>Murray, Caitlin</creatorcontrib><creatorcontrib>Aalfs, Homer</creatorcontrib><creatorcontrib>Abu-El-Haija, Maisam</creatorcontrib><creatorcontrib>Barth, Bradley</creatorcontrib><creatorcontrib>Bellin, Melena D.</creatorcontrib><creatorcontrib>Ellery, Kate</creatorcontrib><creatorcontrib>Fishman, Douglas S.</creatorcontrib><creatorcontrib>Gariepy, Cheryl E.</creatorcontrib><creatorcontrib>Giefer, Matthew J.</creatorcontrib><creatorcontrib>Goday, Praveen</creatorcontrib><creatorcontrib>Gonska, Tanja</creatorcontrib><creatorcontrib>Heyman, Melvin B.</creatorcontrib><creatorcontrib>Husain, Sohail Z.</creatorcontrib><creatorcontrib>Lin, Tom K.</creatorcontrib><creatorcontrib>Liu, Quin Y.</creatorcontrib><creatorcontrib>Mascarenhas, Maria R.</creatorcontrib><creatorcontrib>Maqbool, Asim</creatorcontrib><creatorcontrib>McFerron, Brian</creatorcontrib><creatorcontrib>Morinville, Veronique D.</creatorcontrib><creatorcontrib>Nathan, Jaimie D.</creatorcontrib><creatorcontrib>Ooi, Chee Y.</creatorcontrib><creatorcontrib>Perito, Emily R.</creatorcontrib><creatorcontrib>Pohl, John F.</creatorcontrib><creatorcontrib>Schwarzenberg, Sarah Jane</creatorcontrib><creatorcontrib>Sellers, Zachary M.</creatorcontrib><creatorcontrib>Serrano, Jose</creatorcontrib><creatorcontrib>Shah, Uzma</creatorcontrib><creatorcontrib>Troendle, David</creatorcontrib><creatorcontrib>Zheng, Yuhua</creatorcontrib><creatorcontrib>Yuan, Ying</creatorcontrib><creatorcontrib>Lowe, Mark</creatorcontrib><creatorcontrib>Uc, Aliye</creatorcontrib><creatorcontrib>on behalf of the Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer</creatorcontrib><creatorcontrib>Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer</creatorcontrib><title>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)</title><title>Contemporary clinical trials</title><addtitle>Contemp Clin Trials</addtitle><description>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.
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.
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.</description><subject>Acute recurrent pancreatitis</subject><subject>Children</subject><subject>Chronic pancreatitis</subject><subject>Cognitive-behavioral therapy</subject><subject>Internet intervention</subject><subject>Pain</subject><issn>1551-7144</issn><issn>1559-2030</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9Uk2P0zAQjRCIXRZ-ABfk4yKREsdx4oKEhMqntBI9gDhazmSydZXYXduptPxqfgKTdqlAQpw89rx58zzzsuwpLxa84PXL7QIgLcqCL-ku1VLdy865lMu8LERx_xDzvOFVdZY9inFbFKKWtXyYnQneyFoocZ79_I5t3pqIHQN_7Wyye8xb3Ji99cEMzLqEYY8uWe9Y7wPbGevole2wsyYFC8zAlJAFhCkEAjLjiGsTvKPczjgIaBLxxldsHXzy4Afme2bYOA3JAs4NWKAiP9ofBxkuBT8MFBI9SeiDH1naIItp6m7n2n-xv2Ckp8WE8SDglAIGFFKLy9X63Xr1_HH2oDdDxCd350X27cP7r6tP-dWXj59Xb69yqCRPuYFSFqJSQoCUfckbA20rKtOIDoQC4B0K4H0ljFKgEEEJZbCppKlNL0QpLrI3R97d1I7Yzf-keepdsKMJt9obq__OOLvR136v66UspWiI4PKOIPibCWPSo42Aw2Ac-inqcl6iqhSvCMqPUAg-xoD9qQ0v9OwUvdXkFD07RR-dQjXP_tR3qvhtDQK8PgKQprS3GHQEizTKztKuk-68_Q_9L5-x1yY</recordid><startdate>20200101</startdate><enddate>20200101</enddate><creator>Palermo, Tonya M.</creator><creator>Murray, Caitlin</creator><creator>Aalfs, Homer</creator><creator>Abu-El-Haija, Maisam</creator><creator>Barth, Bradley</creator><creator>Bellin, Melena D.</creator><creator>Ellery, Kate</creator><creator>Fishman, Douglas S.</creator><creator>Gariepy, Cheryl E.</creator><creator>Giefer, Matthew J.</creator><creator>Goday, Praveen</creator><creator>Gonska, Tanja</creator><creator>Heyman, Melvin B.</creator><creator>Husain, Sohail Z.</creator><creator>Lin, Tom K.</creator><creator>Liu, Quin Y.</creator><creator>Mascarenhas, Maria R.</creator><creator>Maqbool, Asim</creator><creator>McFerron, Brian</creator><creator>Morinville, Veronique D.</creator><creator>Nathan, Jaimie D.</creator><creator>Ooi, Chee Y.</creator><creator>Perito, Emily R.</creator><creator>Pohl, John F.</creator><creator>Schwarzenberg, Sarah Jane</creator><creator>Sellers, Zachary M.</creator><creator>Serrano, Jose</creator><creator>Shah, Uzma</creator><creator>Troendle, David</creator><creator>Zheng, Yuhua</creator><creator>Yuan, Ying</creator><creator>Lowe, Mark</creator><creator>Uc, Aliye</creator><general>Elsevier Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20200101</creationdate><title>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)</title><author>Palermo, Tonya M. ; Murray, Caitlin ; Aalfs, Homer ; Abu-El-Haija, Maisam ; Barth, Bradley ; Bellin, Melena D. ; Ellery, Kate ; Fishman, Douglas S. ; Gariepy, Cheryl E. ; Giefer, Matthew J. ; Goday, Praveen ; Gonska, Tanja ; Heyman, Melvin B. ; Husain, Sohail Z. ; Lin, Tom K. ; Liu, Quin Y. ; Mascarenhas, Maria R. ; Maqbool, Asim ; McFerron, Brian ; Morinville, Veronique D. ; Nathan, Jaimie D. ; Ooi, Chee Y. ; Perito, Emily R. ; Pohl, John F. ; Schwarzenberg, Sarah Jane ; Sellers, Zachary M. ; Serrano, Jose ; 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Uzma</creatorcontrib><creatorcontrib>Troendle, David</creatorcontrib><creatorcontrib>Zheng, Yuhua</creatorcontrib><creatorcontrib>Yuan, Ying</creatorcontrib><creatorcontrib>Lowe, Mark</creatorcontrib><creatorcontrib>Uc, Aliye</creatorcontrib><creatorcontrib>on behalf of the Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer</creatorcontrib><creatorcontrib>Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Contemporary clinical trials</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Palermo, Tonya M.</au><au>Murray, Caitlin</au><au>Aalfs, Homer</au><au>Abu-El-Haija, Maisam</au><au>Barth, Bradley</au><au>Bellin, Melena D.</au><au>Ellery, Kate</au><au>Fishman, Douglas S.</au><au>Gariepy, Cheryl E.</au><au>Giefer, Matthew J.</au><au>Goday, Praveen</au><au>Gonska, Tanja</au><au>Heyman, Melvin B.</au><au>Husain, Sohail Z.</au><au>Lin, Tom K.</au><au>Liu, Quin Y.</au><au>Mascarenhas, Maria R.</au><au>Maqbool, Asim</au><au>McFerron, Brian</au><au>Morinville, Veronique D.</au><au>Nathan, Jaimie D.</au><au>Ooi, Chee Y.</au><au>Perito, Emily R.</au><au>Pohl, John F.</au><au>Schwarzenberg, Sarah Jane</au><au>Sellers, Zachary M.</au><au>Serrano, Jose</au><au>Shah, Uzma</au><au>Troendle, David</au><au>Zheng, Yuhua</au><au>Yuan, Ying</au><au>Lowe, Mark</au><au>Uc, Aliye</au><aucorp>on behalf of the Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer</aucorp><aucorp>Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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)</atitle><jtitle>Contemporary clinical trials</jtitle><addtitle>Contemp Clin Trials</addtitle><date>2020-01-01</date><risdate>2020</risdate><volume>88</volume><spage>105898</spage><epage>105898</epage><pages>105898-105898</pages><artnum>105898</artnum><issn>1551-7144</issn><eissn>1559-2030</eissn><abstract>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.
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.
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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>31756383</pmid><doi>10.1016/j.cct.2019.105898</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Contemporary clinical trials, 2020-01, Vol.88, p.105898-105898, Article 105898 |
| issn | 1551-7144 1559-2030 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6952537 |
| source | Elsevier ScienceDirect Journals |
| subjects | Acute recurrent pancreatitis Children Chronic pancreatitis Cognitive-behavioral therapy Internet intervention Pain |
| title | 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) |
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