[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563581":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":91,"collaborators":93,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":23,"eligibilityCriteria":107,"healthyVolunteers":104,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":26,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":73,"whyStopped":26,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Children's National Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mindfulness-Based Intervention, BREATHE-T1D","EXPERIMENTAL","Learning to BREATHE, an existing group-based mindfulness intervention, was adapted in a prior trial, using the input of teens with T1D, to utilize mindfulness as a strategy for supporting the management of T1D. The intervention is 7 sessions, one per week, 60-90 minutes each and teaches mindfulness strategies and promotes connection with other teens with T1D.",[13],"Behavioral: BREATHE-T1D",{"label":15,"type":16,"description":17,"interventionNames":18},"Diabetes Education and Support, HealthEd-T1D","PLACEBO_COMPARATOR","HealthEd-T1D was designed using input of teens with T1D to be a 6 session, 60 minutes once per week program to promote knowledge and empowerment in diabetes management as well as to encourage connection with other teens with T1D.",[19],"Behavioral: HealthEd-T1D",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","BREATHE-T1D","BREATHE-T1D was adapted from Learning to BREATHE, a group mindfulness-based intervention for teens. It teaches mindfulness strategies adapted to be specific and relatable to, teens with T1D to improves symptoms of depression and anxiety as well as diabetes self-management.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"HealthEd-T1D","HealthEd-T1D is a 6 week, virtual, group based diabetes education group.",[15],[32],{"name":33,"affiliation":34,"role":35},"Eleanor Mackey, PhD","children's national hospital","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","202-476-5307","emackey@childrensnational.org",[42,71],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Barbara Davis Center","NOT_YET_RECRUITING","Aurora","Colorado","80045","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-104.83192,39.72943,{"lat":54,"lon":53},[57,61,62,65,67,69],{"name":58,"role":38,"phone":59,"phoneExt":26,"email":60},"Todd Alonso, MD","303-724-2323","Todd.Alonso@cuanschutz.edu",{"name":58,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":63,"role":64,"phone":26,"phoneExt":26,"email":26},"Holly O'Donnell, PhD","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":26,"phoneExt":26,"email":26},"Bethany Kwan, PhD",{"name":68,"role":64,"phone":26,"phoneExt":26,"email":26},"Lauren Shomaker, PhD",{"name":70,"role":64,"phone":26,"phoneExt":26,"email":26},"Laura Pyle, PhD",{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":48,"countryCode":49,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Children's National Hospital","RECRUITING","Washington D.C.","District of Columbia","20010",{"type":51,"coordinates":78},[79,80],-77.03637,38.89511,{"lat":80,"lon":79},[83,85,87,89],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":84},"breathet1d@childrensnational.org",{"name":86,"role":64,"phone":26,"phoneExt":26,"email":26},"Randi Streisand, PhD",{"name":88,"role":64,"phone":26,"phoneExt":26,"email":26},"Molly Basch, PhD",{"name":90,"role":64,"phone":26,"phoneExt":26,"email":26},"Shideh Majidi, MD",{"type":92,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[94,97,99],{"name":95,"class":96},"Barbara Davis Center of Childhood Diabetes, University of Co","UNKNOWN",{"name":98,"class":6},"Colorado State University",{"name":100,"class":101},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100563581","pragmatic-clinic-based-trial-of-a-mindfulness-based-intervention-for-mood-concerns-in-youth-with-type-1-diabetes-100563581",false,"NCT06618027","Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth With Type 1 Diabetes","Inclusion Criteria:\n\n* Type 1 diabetes diagnosed for at least 1 year\n* Elevated score on depression measure OR elevated score on anxiety measure\n\nExclusion Criteria:\n\n* Cognitive or developmental delays that restrict ability to complete study interventions or assessments\n* Teen not fluent in English\n* No other serious medical conditions (e.g., cystic fibrosis, cancer)","ALL","13 Years","17 Years",{"count":112,"type":113},200,"ESTIMATED","INTERVENTIONAL",[116],"NA","Type 1 diabetes (T1D) is a common chronic illness among children requiring a high degree of self-management for good glycemic control. Adolescents are at risk for poor disease management and health outcomes due to a number of factors, including high rates of depression, anxiety, and stress. Accessing support for these challenges can be a barrier to care, so the current study, BRinging Empowerment and Attention to Teen HEalth-T1D, evaluates the efficacy of a virtual, group-based mindfulness based intervention and a virtual group-based diabetes education intervention on improving symptoms of depression and anxiety, and diabetes self management in teens with T1D. The study also aims to study how these interventions might be implemented in diabetes clinic settings.",[119],"Type 1 Diabetes (T1D)",[121,122,123,124],"type 1 diabetes","adolescents","depression","anxiety","2025-07-07",{"date":127,"type":128},"2025-07-08","ACTUAL",{"date":130,"type":128},"2025-05-15",{"date":132,"type":113},"2029-08-06",{"name":5,"class":6},2]