[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544849":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":41,"studyPopulation":33,"armGroups":42,"interventions":60,"overallOfficials":76,"centralContacts":84,"locations":90,"responsibleParty":339,"collaborators":342,"id":346,"slug":347,"hasResults":348,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":348,"sex":354,"minAge":355,"maxAge":356,"enrollmentInfo":357,"targetDuration":33,"studyType":360,"phases":361,"briefSummary":363,"conditions":364,"keywords":367,"overallStatus":93,"whyStopped":33,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":380},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"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","Mean change in pain intensity as measured by the Pain, Enjoyment of Life and General Activity (PEG-3) scale. Item 1 asks individuals to rate their pain, on average, over the past week, using a 0-10 rating scale.","Baseline and 6 months",{"measure":14,"description":15,"timeFrame":12},"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","Mean change in pain interference as measured by the PEG-3 items 2 and 3 that ask individuals to rate how pain has interfered with their enjoyment and general activities, in the past week, using a 0-10 rating scale.",[17,20,23,26,28,31],{"measure":18,"description":19,"timeFrame":12},"Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain intensity for AYAs with SCD and chronic pain","Mean change in pain intensity as measured by the PEG-3",{"measure":21,"description":22,"timeFrame":12},"Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain interference for AYAs with SCD and chronic pain","Mean change in pain interference as measured by the PEG-3",{"measure":24,"description":19,"timeFrame":25},"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","Baseline and 12 months",{"measure":27,"description":22,"timeFrame":25},"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",{"measure":29,"description":19,"timeFrame":30},"Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain intensity of AYAs with SCD and chronic pain","Baseline and 12 Months",{"measure":32,"description":22,"timeFrame":30},"Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain interferences of AYAs with SCD and chronic pain",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"RANDOMIZED","PARALLEL","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","TREATMENT",{"masking":40,"maskingDescription":33,"whoMasked":33},"NONE","The PRESENCE study aims to address the pressing issue of inadequate pain management for adolescents and young adults (AYAs) with sickle cell disease (SCD). Despite pain being the primary clinical symptom of SCD, effective treatment options are limited, leading to repeated hospitalizations and negative impacts on patients' physical and mental well-being. Opioids, the primary treatment for chronic SCD pain, often fail to provide long-term relief and can result in harmful consequences.\n\nRecognizing the need for alternative approaches, the study hopes to investigate the effectiveness of digital cognitive behavioral therapy (CBT), both with and without personalized peer support delivered through community-based organizations (CBOs). CBT is a well-established method for managing pain in the general population, and digital CBT has shown promise in improving outcomes for individuals with chronic conditions.\n\nThe study will involve a multisite, randomized controlled trial with 390 AYAs with SCD who have experienced frequent pain over the past three months. Participants will be randomized into one of three groups:\n\n1. Digital CBT with weekly one-on-one peer support (CBT+peer)\n2. Digital CBT without peer support (self-guided CBT)\n3. Usual care (UC)\n\nThe primary hypotheses of the study are:\n\nHypothesis 1. AYAs receiving any digital CBT (CBT + peer or self-guided CBT) will have greater improvements in primary pain outcomes (PEG-3 pain intensity and pain interference), and larger decreases in secondary pain outcomes (mean daily pain intensity, pain days, average weekly opioid dose, emergency department visits, hospitalizations) and in psychological outcomes (MoSCS internalized stigma, SCSES sickle cell self-efficacy, PHQ-9M depression, GAD-7 anxiety) than AYAs receiving UC at 6 months post initiation of intervention.\n\nHypothesis 2. AYAs receiving CBT + peer will have greater improvements in the primary and secondary outcomes described above at 6 months, and greater app engagement, than AYAs receiving self-guided CBT.\n\nThis study will have the following assessment time points.\n\n* Baseline = pre-randomization baseline measures\n\n  o Rescreen if SCD verification is not provided within 30 days\n* At Randomization = Pain and mood diary using Ecological Momentary Assessment (EMA) assessed daily for a total of 14 days with the first entry occuring immediately prior to randomization\u002Fintervention start and then continuing daily post-randomization\n* 3-month = end of intervention period assessment 90 days (3 months) post -randomization\n* 6-month = primary endpoint 180 days (6 months) post-randomization\n* 12-month = long-term endpoint 365 days (12 months) post-randomization\n\nThe study intervention and EMA data collection is performed via an iOS and Android application called CaRISMA that will be called \"the app\" or the \"CaRISMA app\" hereafter.",[43,49,55],{"label":44,"type":45,"description":46,"interventionNames":47},"CBT w\u002F Health Coach","EXPERIMENTAL","Group will utilize the Presence app to undergo self CBT for EMA, but with addition of peer health coaches.",[48],"Behavioral: CBT+ Health coach",{"label":50,"type":51,"description":52,"interventionNames":53},"CBT w\u002Fo Health coach (self-guided)","ACTIVE_COMPARATOR","Group will utilize the Presence app to undergo self-guided CBT for EMA, but without peer health coaches.",[54],"Behavioral: CBT w\u002Fo Health Coach ( self-guided)",{"label":56,"type":51,"description":57,"interventionNames":58},"Usual Care with no access to CBT","Participants in the UC group will have access to CaRISMA app to complete a daily pain and mood e-diary, daily record of opiate use, and weekly assessment of pain via the Painimation tool. All other care will be at the discretion of their treating provider",[59],"Behavioral: Usual Care",[61,68,72],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"BEHAVIORAL","CBT+ Health coach","Participants will complete the pre-enrollment clinical screening measures (PHQ-9M, GAD-7, and PEG-3) and will repeat those assessments, as well as outcome assessments, at 3 months, 6 months, and 12 months. Participants in CBT w\u002F Health coach group will engage with the CaRISMA app to complete a daily pain and mood e-diary, daily record of opiate use, and weekly assessment of pain via the Painimation tool. In addition participants will have weekly contact with a peer health coach.",[44],[67],"CBT+peer",{"type":62,"name":69,"description":70,"armGroupLabels":71,"otherNames":33},"CBT w\u002Fo Health Coach ( self-guided)","Participants will complete the pre-enrollment clinical screening measures (PHQ-9M, GAD-7, and PEG-3) and will repeat those assessments, as well as outcome assessments, at 3 months, 6 months, and 12 months. Participants CBT w\u002Fo Health coach groups will engage with the CaRISMA app to complete a daily pain and mood e-diary, daily record of opiate use, and weekly assessment of pain via the Painimation tool.",[50],{"type":62,"name":73,"description":74,"armGroupLabels":75,"otherNames":33},"Usual Care","Participants will complete the pre-enrollment clinical screening measures (PHQ-9M, GAD-7, and PEG-3) and will repeat those assessments, as well as outcome assessments, at 3 months, 6 months, and 12 months. Participants in the UC group will be asked to engage with the CaRISMA app to complete a daily pain and mood e-diary, daily record of opiate use, and weekly assessment of pain via the Painimation tool. All other care will be at the discretion of their treating provider",[56],[77,80,82],{"name":78,"affiliation":5,"role":79},"Ana Radovic, MD","PRINCIPAL_INVESTIGATOR",{"name":81,"affiliation":5,"role":79},"Alicia Colvin, PhD",{"name":83,"affiliation":5,"role":79},"Bruce Rollman, MD",[85],{"name":86,"role":87,"phone":88,"phoneExt":33,"email":89},"Steffi Siebert, MPH","CONTACT","877-649-0176","presencestudy@pitt.edu",[91,118,135,152,173,190,207,224,240,256,273,289,305,322],{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"University of South Alabama Medical Center","RECRUITING","Mobile","Alabama","36617","United States","US",{"type":100,"coordinates":101},"Point",[102,103],-88.04305,30.69436,{"lat":103,"lon":102},[106,110,113,115],{"name":107,"role":87,"phone":108,"phoneExt":33,"email":109},"Jessica King","(251) 445-9159","jlking@health.southalabama.edu",{"name":111,"role":87,"phone":33,"phoneExt":33,"email":112},"T'Shemika Perryman","tperryman@health.southalabama.edu",{"name":114,"role":79,"phone":33,"phoneExt":33,"email":33},"Antwan Hogue, MD",{"name":116,"role":117,"phone":33,"phoneExt":33,"email":33},"Ardie Pack-Mabien, PhD","SUB_INVESTIGATOR",{"facility":119,"status":93,"city":120,"state":121,"zip":122,"country":97,"countryCode":98,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"UCLA Mattel Children's Hospital Ronald Reagan Hospital","Los Angeles","California","90095",{"type":100,"coordinates":124},[125,126],-118.24368,34.05223,{"lat":126,"lon":125},[129,133],{"name":130,"role":87,"phone":131,"phoneExt":33,"email":132},"Debbie Argueta Rufino","(424) 362-0037","darguetarufino@mednet.ucla.edu",{"name":134,"role":79,"phone":33,"phoneExt":33,"email":33},"Satiro De Oliveira, MD",{"facility":136,"status":93,"city":137,"state":138,"zip":139,"country":97,"countryCode":98,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Connecticut Children's Medical Center","Hartford","Connecticut","06106",{"type":100,"coordinates":141},[142,143],-72.68509,41.76371,{"lat":143,"lon":142},[146,150],{"name":147,"role":87,"phone":148,"phoneExt":33,"email":149},"Christopher Theriault","(860) 837-5852","ctheriault@connecticutchildrens.org",{"name":151,"role":79,"phone":33,"phoneExt":33,"email":33},"William Zempsky, MD",{"facility":153,"status":93,"city":154,"state":155,"zip":156,"country":97,"countryCode":98,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Children's Healthcare of Atlanta","Atlanta","Georgia","30345",{"type":100,"coordinates":158},[159,160],-84.38798,33.749,{"lat":160,"lon":159},[163,167,171],{"name":164,"role":87,"phone":165,"phoneExt":33,"email":166},"Katyria Thornton","(404) 785-6274","katyria.thornton@choa.org",{"name":168,"role":87,"phone":169,"phoneExt":33,"email":170},"Vontarius Howard Jesse","(404) 785-3245","vontarius.howard@choa.org",{"name":172,"role":79,"phone":33,"phoneExt":33,"email":33},"Carlton Dampier, MD",{"facility":174,"status":93,"city":175,"state":176,"zip":177,"country":97,"countryCode":98,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Ann and Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"type":100,"coordinates":179},[180,181],-87.65005,41.85003,{"lat":181,"lon":180},[184,188],{"name":185,"role":87,"phone":186,"phoneExt":33,"email":187},"Kevin Guerrero","(312) 227-4824","kguerrero@lueriechildrens.org",{"name":189,"role":79,"phone":33,"phoneExt":33,"email":33},"Robert Liem, MD",{"facility":191,"status":93,"city":192,"state":193,"zip":194,"country":97,"countryCode":98,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"The Regents of the University of Michigan","Ann Arbor","Michigan","48109-1079",{"type":100,"coordinates":196},[197,198],-83.74088,42.27756,{"lat":198,"lon":197},[201,205],{"name":202,"role":87,"phone":203,"phoneExt":33,"email":204},"Anela Mukherjee","7342329896","mukherja@med.umich.edu",{"name":206,"role":79,"phone":33,"phoneExt":33,"email":33},"Eric Scott, PhD",{"facility":208,"status":93,"city":209,"state":210,"zip":211,"country":97,"countryCode":98,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Rutgers New Jersey Medical School","Newark","New Jersey","07103",{"type":100,"coordinates":213},[214,215],-74.17237,40.73566,{"lat":215,"lon":214},[218,222],{"name":219,"role":87,"phone":220,"phoneExt":33,"email":221},"Kim White","(732) 277-7703","whiteka@rwjms.rutgers.edu",{"name":223,"role":79,"phone":33,"phoneExt":33,"email":33},"Ashwin Sridharan, MD",{"facility":225,"status":93,"city":226,"state":226,"zip":227,"country":97,"countryCode":98,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"Weil Cornell Medical College","New York","10065",{"type":100,"coordinates":229},[230,231],-74.00597,40.71427,{"lat":231,"lon":230},[234,238],{"name":235,"role":87,"phone":236,"phoneExt":33,"email":237},"Masiel Infante","646-962-8311","mai4011@med.cornell.edu",{"name":239,"role":79,"phone":33,"phoneExt":33,"email":33},"Maria DeSancho, MD",{"facility":241,"status":93,"city":242,"state":226,"zip":243,"country":97,"countryCode":98,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"University of Rochester Medical Center","Rochester","14642",{"type":100,"coordinates":245},[246,247],-77.61556,43.15478,{"lat":247,"lon":246},[250,254],{"name":251,"role":87,"phone":252,"phoneExt":33,"email":253},"Priya Kaushal","(585) 275-2981","priya_kaushal@urmc.rochester.edu",{"name":255,"role":79,"phone":33,"phoneExt":33,"email":33},"Suzie Noronha, MD",{"facility":257,"status":93,"city":258,"state":259,"zip":260,"country":97,"countryCode":98,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Wake Forest Baptist Hospital","Durham","North Carolina","27106",{"type":100,"coordinates":262},[263,264],-78.89862,35.99403,{"lat":264,"lon":263},[267,271],{"name":268,"role":87,"phone":269,"phoneExt":33,"email":270},"Julie Fountain","(980) 442-2000","Julie.Fountain@Advocatehealth.org",{"name":272,"role":79,"phone":33,"phoneExt":33,"email":33},"Alex George, MD",{"facility":274,"status":93,"city":275,"state":259,"zip":276,"country":97,"countryCode":98,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"East Carolina University Health Medical Center","Greenville","27834",{"type":100,"coordinates":278},[279,280],-77.36635,35.61266,{"lat":280,"lon":279},[283,287],{"name":284,"role":87,"phone":285,"phoneExt":33,"email":286},"Toria Wilson","(252) 744-0493","wilsonto22@ecu.edu",{"name":288,"role":79,"phone":33,"phoneExt":33,"email":33},"Darla Liles, MD",{"facility":290,"status":93,"city":291,"state":292,"zip":293,"country":97,"countryCode":98,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"UPMC University of Pittsburgh Classical Hematology Adult Clinic","Pittsburgh","Pennsylvania","15213",{"type":100,"coordinates":295},[296,297],-79.99589,40.44062,{"lat":297,"lon":296},[300,302,304],{"name":86,"role":87,"phone":301,"phoneExt":33,"email":89},"8776490176",{"name":303,"role":79,"phone":33,"phoneExt":33,"email":33},"Laura De Castro, MD",{"name":78,"role":79,"phone":33,"phoneExt":33,"email":33},{"facility":306,"status":93,"city":291,"state":292,"zip":307,"country":97,"countryCode":98,"cosmosGeoPoint":308,"geoPoint":310,"contacts":311},"UPMC Children's Hospital of Pittsburgh","15224",{"type":100,"coordinates":309},[296,297],{"lat":297,"lon":296},[312,316,320],{"name":313,"role":87,"phone":314,"phoneExt":33,"email":315},"Alex Berkebile","412-692-5964","berkebileak@upmc.edu",{"name":317,"role":87,"phone":318,"phoneExt":33,"email":319},"Amy Travis","412-692-8575","travisam@upmc.edu",{"name":321,"role":79,"phone":33,"phoneExt":33,"email":33},"Dr. Cheryl Hillery, MD",{"facility":323,"status":93,"city":324,"state":325,"zip":326,"country":97,"countryCode":98,"cosmosGeoPoint":327,"geoPoint":331,"contacts":332},"Virginia Commonwealth University","Richmond","Virginia","23284",{"type":100,"coordinates":328},[329,330],-77.46026,37.55376,{"lat":330,"lon":329},[333,337],{"name":334,"role":87,"phone":335,"phoneExt":33,"email":336},"Danie Sop, PhD","(804) 828-0810","daniel.sop@vcuhealth.org",{"name":338,"role":79,"phone":33,"phoneExt":33,"email":33},"Wally Smith, MD",{"type":79,"investigatorFullName":340,"investigatorTitle":341,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Bruce Rollman","Professor",[343],{"name":344,"class":345},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100544849","peer-support-for-adolescents-and-emerging-adults-with-sickle-cell-pain-100544849",false,"NCT06374238","Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain","Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain: Promoting Engagement in Cognitive Behavioral Therapy","PRESENCE","Inclusion Criteria:\n\n1. Aged 16 to 39 years of age at time of enrollment\n2. Sickle Cell Disease diagnosis of any genotype based on referral or documentation\n3. Reports chronic pain (≥4 days\u002Fweek for past 3 months or more) OR A) Being prescribed pain medication to be taken (≥4 days\u002Fweek for past 3 months or more) OR B) Taking pain medication (≥4 days\u002Fweek for past 3 months or more) OR C) Receiving non-pharmaceutical pain treatment (≥4 days\u002Fweek for past 3 months or more)\n4. Access to an iOS or Android mobile device with internet access\n\nExclusion Criteria:\n\n1. Unable to speak or read English\n2. Prior hematopoietic stem cell transplant for sickle cell disease\n3. Not living in the United States throughout enrollment and duration of the study period","ALL","16 Years","39 Years",{"count":358,"type":359},390,"ESTIMATED","INTERVENTIONAL",[362],"NA","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.\n\nBy 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.",[365,366],"Pain","Sickle Cell Disease",[366,368,369,370],"Pain management","Cognitive Behavioral Therapy","Wellness","2026-10-04",{"date":373,"type":374},"2026-10-08","ACTUAL",{"date":376,"type":374},"2025-03-10",{"date":378,"type":359},"2028-08",{"name":5,"class":6},14]