protocolSection identificationModule nctId: NCT06374238, orgStudyIdInfo id: UG3HL165839, type: NIH, link: https://reporter.nih.gov/quickSearch/UG3HL165839, secondaryIdInfos id: UG3HL165839, type: NIH, link: https://reporter.nih.gov/quickSearch/UG3HL165839, briefTitle: Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain, acronym: PRESENCE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The study, known as the Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE), aims to determine the effectiveness of digital CBT in reducing pain, opioid use, and healthcare utilization among AYAs with SCD. It also seeks to understand the role of personalized peer support in enhancing engagement and outcomes of digital CBT interventions.By leveraging existing infrastructure for delivering virtual peer support interventions, tailored digital CBT programs for individuals with SCD, and partnerships with CBOs, the study aims to provide valuable insights into the feasibility and effectiveness of digital CBT as a pain management strategy for this vulnerable population., conditionsModule conditions: Pain, conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Three-arm, phase III randomized controlled effectiveness trial. Participants will be randomized 3:3:2 into (1) CBT + peer, (2) self-guided CBT, or (3) UC, stratified by site, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 470, type: ESTIMATED, armsInterventionsModule interventions name: CBT+ Health coach, interventions name: CBT w/o Health Coach ( self-guided), interventions name: Usual Care, outcomesModule primaryOutcomes measure: Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain intensity for AYAs with SCD and chronic pain, primaryOutcomes measure: Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain interference for AYAs with SCD and chronic pain, secondaryOutcomes measure: Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain intensity for AYAs with SCD and chronic pain, secondaryOutcomes measure: Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain interference for AYAs with SCD and chronic pain, secondaryOutcomes measure: Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain intensity for AYAs with SCD and chronic pain, secondaryOutcomes measure: Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain interference for AYAs with SCD and chronic pain, secondaryOutcomes measure: Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain intensity of AYAs with SCD and chronic pain, secondaryOutcomes measure: Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain interferences of AYAs with SCD and chronic pain, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False