[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495677":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":45,"responsibleParty":76,"collaborators":78,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":26,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Albert Einstein College of Medicine","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring","EXPERIMENTAL","Participants randomized to this arm will receive the Unified Protocol for Cognitive Behavioral Therapy (UP-CBT), enhanced by review of Continuous Glucose Monitoring (CGM) data. Participants will wear study-supplied CGM for the first 6 months of their participation in the trial.",[13,14],"Behavioral: Unified protocol for cognitive behavioral therapy (UP-CBT)","Device: Continuous Glucose Monitoring (CGM)",{"label":16,"type":17,"description":18,"interventionNames":19},"Continuous Glucose Monitoring (CGM) Only","ACTIVE_COMPARATOR","Participants randomized to receive Continuous Glucose Monitoring (CGM) will continue to receive their usual care and will also wear CGM throughout the first 6 months of their participation in the trial.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Unified protocol for cognitive behavioral therapy (UP-CBT)","UP-CBT consists of approximately 16 individual sessions of CBT, conducted over the course of approximately 20 weeks. The UP-CBT consists of 5 core modules targeting negative emotionality and aversive reactions to emotional experiences. These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. The final module consists of relapse prevention. UP-CBT sessions will integrate a review of Continuous Glucose Monitoring (CGM) data and feedback will be provided by the therapist.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DEVICE","Continuous Glucose Monitoring (CGM)","Use of commercially available, FDA-approved continuous glucose monitoring (CGM) for 6 months post-randomization. Usual diabetes care will continue and participants can initiate a CGM review from their healthcare providers, as desired. In addition, a nurse practitioner with expertise in CGM will train each participant via video recordings in the proper placement of the device, and technical issues, and provide basic teaching at the beginning of the trial on interpretation of CGM data and self-titration of insulin\u002Fself-management. Written materials and online resources for recognizing and managing anxiety and depressive disorders, along with self-management information and treatment options to discuss with providers will also be provided.",[16,9],[33],{"name":34,"affiliation":5,"role":35},"Jeffrey Gonzalez, PhD","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","646-592-4506","jeffrey.gonzalez@yu.edu",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Keyla Ordonez, BS","631-747-9325","keyla.ordonez@einsteinmed.edu",[46,64],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Boston University","RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-71.05977,42.35843,{"lat":58,"lon":57},[61],{"name":62,"role":38,"phone":26,"phoneExt":26,"email":63},"Todd Farchione, PhD","tfarchio@bu.edu",{"facility":5,"status":48,"city":65,"state":66,"zip":67,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"The Bronx","New York","10461",{"type":55,"coordinates":69},[70,71],-73.86641,40.84985,{"lat":71,"lon":70},[74,75],{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},{"name":34,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[79,81],{"name":80,"class":6},"Juvenile Diabetes Research Foundation",{"name":82,"class":83},"DexCom, Inc.","INDUSTRY","100495677","telemedicine-delivered-unified-protocol-for-cognitive-behavioral-therapy-for-anxiety-and-depression-100495677",false,"NCT05734313","Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression","Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression in Young Adults With Type 1 Diabetes","UP-CBT","Inclusion Criteria:\n\n* Type 1 diabetes (T1D) duration ≥ 6 months\n* 18-64 years old\n* English- or Spanish-speaking\n* Anxiety or depressive mood disorder as per structured diagnostic interview.\n\nExclusion Criteria:\n\n* Developmental or sensory disability interfering with participation\n* Current pregnancy\n* Bipolar disorders, psychotic disorders, severe eating disorders, severe substance abuse disorders, or acute suicidal risk or self-harm\n* Use of medications or recent medical procedures that would impact glycemic control or use of continuous glucose monitoring (CGM) over the study\n* Received cognitive behavioral therapy (CBT) in last year or plans to initiate CBT; (6) temporary exclusion for recent initiation of psychotropic medication - must be on a stable dose for 6 weeks prior to enrollment.","ALL","18 Years","64 Years",{"count":96,"type":97},94,"ESTIMATED","INTERVENTIONAL",[100],"NA","This project will evaluate a telemedicine-delivered, Unified Protocol for Cognitive-Behavioral Therapy (UP-CBT) enhanced with continuous glucose monitor (CGM) review to target anxiety and depressive symptoms and glycemic control in adults with type 1 diabetes.",[103,104],"Diabetes","Type 1 Diabetes",[103,104,106,107,108,109,110],"Depression","Anxiety","Diabetes Distress","Diabetes Management","Diabetes Self-Care","2025-10-29",{"date":113,"type":114},"2025-10-30","ACTUAL",{"date":116,"type":114},"2023-03-31",{"date":118,"type":97},"2027-12",{"name":5,"class":6},2]