protocolSection identificationModule nctId: NCT06386224, orgStudyIdInfo id: 1R01DK137520-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DK137520-01, briefTitle: Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain, acronym: IMPACT-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Seattle Children's Hospital, class: OTHER, collaborators name: University of Kentucky, descriptionModule briefSummary: Severe and disabling abdominal pain is common in individuals with chronic pancreatitis. Although pain is associated with reduced quality of life and high economic and societal costs, there are limited effective options for pain management in this population. This study proposes an evidence-based psychological intervention approach using an internet-delivered pain self-management program to minimize the impact of pain and improve quality of life. The ultimate goal is to maximize the public health impact of the intervention with successful implementation and dissemination to pancreas clinics and to the community., conditionsModule conditions: Pancreatitis, conditions: Chronic Pancreatitis, conditions: Acute Recurrent Pancreatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants randomized to the active intervention arm will receive access to the Pancreatitis Pain Course to learn cognitive-behavioral (CBT) pain self-management skills (e.g., changing negative thoughts, relaxation, activity pacing, goal setting). Participants randomized to the control arm will receive access to an education website., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: Participants are not informed of their condition assignment and both receive online programs for chronic pancreatitis. Investigators are blinded \& masked to study condition, and all outcomes are assessed via self-reported REDCap surveys. Care providers are not involved in the study (N/A)., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Internet-delivered pain self-management (CBT Condition), interventions name: Education Program, outcomesModule primaryOutcomes measure: Change in pain severity and pain interference, secondaryOutcomes measure: Change in disease-specific pain, secondaryOutcomes measure: Change in physical functioning, secondaryOutcomes measure: Change in psychological functioning, secondaryOutcomes measure: Change in pain catastrophizing, secondaryOutcomes measure: Change in sleep disturbance, secondaryOutcomes measure: Change in disease specific health-related quality of life, secondaryOutcomes measure: Change in patient global impression of change, secondaryOutcomes measure: Change in opioid use, secondaryOutcomes measure: Treatment acceptability, secondaryOutcomes measure: Change in substance use, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seattle Children's Hospital, city: Seattle, state: Washington, zip: 98105, country: United States, contacts name: Tonya Palermo, PhD, role: CONTACT, phone: 206-884-4208, email: tonya.palermo@seattlechildrens.org, contacts name: Tonya M Palermo, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False