NCT03707431|CompletedResultsDMC
Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis
A Randomized Trial of a Web-based Non-pharmacological Pain Intervention for Pediatric Chronic Pancreatitis
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Sponsor study identifier
interventional
90
1 country
1
Study Start
April 25, 2019
Actual (reported)Primary Completion
July 31, 2024
Actual (reported)Study Completion
July 31, 2024
Actual (reported)Abdominal pain is common in children with chronic and acute recurring pancreatitis (CP, ARP), and as they continue into adulthood, the disease progresses with increased pain and greater exposure to opioids. Despite the relevancy of early pain self-management for childhood pancreatitis, there have been no studies of non-pharmacological pain intervention in this population. The proposed project will evaluate a web-based cognitive behavioral pain management program delivered to a cohort of well-phenotyped children with CP/ARP and some community participants to reduce pain, pain-related disability and enhance HRQOL; it will also identify genetic risk factors and clinical and behavioral phenotypic factors associated with treatment response to enable precision medicine approaches.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2, 2018
Actual (reported)October 16, 2018
Actual (reported)April 25, 2019
Actual (reported)July 31, 2024
Actual (reported)July 31, 2024
Actual (reported)April 9, 2026
Actual (reported)Change in Adolescent Abdominal Pain Severity
The Abdominal Pain Index (API) assesses characteristics of abdominal pain during the previous 2 weeks including the number of days with pain, number of pain episodes per day, typical pain episode duration, and typical pain intensity. An index is computed with higher scores indicating greater abdominal pain severity. A mean score is reported on a scale of 0 to 4, where higher values indicate more severe (worse) abdominal pain severity.
Baseline, 12 weeks, 6 months
Change in Pain-related Disability
Baseline, 12 weeks, 6 months
Change in Health-related Quality of Life
Baseline, 12 weeks, 6 months
Change in Emotional Distress
Baseline, 12 weeks, 6 months
Change in Opioid Use
Baseline, 6 months
Change in Pain Self-efficacy
Baseline, 12 weeks, 6 months
Receives access to WebMAP
Receives access to WebED
The eight child modules include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) deep breathing and relaxation, 4) implementing coping skills at school, 5) cognitive skills (e.g., reducing negative thoughts), 6) lifestyle interventions, 7) staying active (e.g., pleasant activity scheduling), 8) relapse prevention. The eight parent modules are: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I (using attention and praise to increase coping), 4) operant strategies II (using rewards to increase positive coping and reach school goals), 5) modeling, 6) lifestyle, 7) communication, 8) relapse prevention.
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Palermo TM, Murray C, Aalfs H, Abu-El-Haija M, Barth B, Bellin MD, Ellery K, Fishman DS, Gariepy CE, Giefer MJ, Goday P, Gonska T, Heyman MB, Husain SZ, Lin TK, Liu QY, Mascarenhas MR, Maqbool A, McFerron B, Morinville VD, Nathan JD, Ooi CY, Perito ER, Pohl JF, Schwarzenberg SJ, Sellers ZM, Serrano J, Shah U, Troendle D, Zheng Y, Yuan Y, Lowe M, Uc A; Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer. 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). Contemp Clin Trials. 2020 Jan;88:105898. doi: 10.1016/j.cct.2019.105898. Epub 2019 Nov 19.
Palermo TM, Li R, Zhou C, Aalfs H, Cress G, Lowe M, Abu-El-Haija M, Chugh A, Downs EM, Fishman DS, Freeman AJ, Giefer MJ, Gonska TY, Husain SZ, Lindblad D, Liu QY, Maqbool A, Mark JA, McFerron BA, Mehta MS, Noel RA, Perito ER, Wang F, Yuan Y, Zheng Y, Uc A; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Internet-delivered Cognitive-Behavioral Intervention for Pain in Pediatric Acute Recurrent and Chronic Pancreatitis: A Multicenter Randomized Controlled Trial. Pancreas. 2026 Feb 1;55(2):e137-e146. doi: 10.1097/MPA.0000000000002558.
We relied on a self-reported diagnosis of ARP or CP for adolescents from the community, which may be inaccurate, and could have impacted our ability to distinguish between diagnostic groups. In addition, we did not reach our enrollment goal due to the COVID-19 pandemic's impact on clinic visits and a lower frequency of pain complaints than anticipated, causing many participants to be ineligible. This made it less likely we would statistically detect a small or moderate effect ("underpowered").
Tonya Palermo, PhD
Seattle Children's Hospital
Aliye Uc, MD
University of Iowa
90 participants (actual enrollment reported by the registry).
First Submitted
October 2, 2018
First Posted
October 16, 2018
Study Start
The pain education website provides publicly available educational information about pancreatitis and abdominal pain. There is general information about pancreatitis from available web sources (e.g., National Pancreas Foundation) as well as information about chronic pain in childhood. The content does not include any instruction in the behavioral and cognitive skills taught within the WebMAP program.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
April 25, 2019
Primary Completion
July 31, 2024
Actual (reported)Study Completion
July 31, 2024
Actual (reported)Last Updated
April 9, 2026
Results First Posted
April 9, 2026
Record last verified: 2026-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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