[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434186":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":36,"locations":45,"responsibleParty":61,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":25,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":25,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Scripps Whittier Diabetes Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ACT1VATE","EXPERIMENTAL","Participants assigned to the intervention group will be offered a psychological intervention specifically designed to address diabetes-related emotional distress.",[13],"Behavioral: ACT1VATE",{"label":15,"type":16,"description":17,"interventionNames":18},"DSME\u002FS (usual care)","ACTIVE_COMPARATOR","Participants randomized to the usual care group will be offered standard diabetes self-management education and support (DSME\u002FS).",[19],"Behavioral: DSME\u002FS",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","ACT1VATE, informed by Acceptance and Commitment Therapy (ACT), will consist of five, 90-minute group-based telemedicine therapy sessions delivered by a Behavioral Health Provider.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"DSME\u002FS","Diabetes self-management education and support (DSME\u002FS) will be delivered by a Certified Diabetes Care and Education Specialist via one-on-one telemedicine format.",[15],[31,34],{"name":32,"affiliation":5,"role":33},"Addie Fortmann, PhD","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":33},"Athena Philis-Tsimikas, MD",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Haley Sandoval","CONTACT","970-497-6701","sandoval.haley@scrippshealth.org",{"name":32,"role":39,"phone":43,"phoneExt":25,"email":44},"858-922-2276","fortmann.adelaide@scrippshealth.org",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","San Diego","California","92121","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-117.16472,32.71571,{"lat":57,"lon":56},[60],{"name":32,"role":39,"phone":43,"phoneExt":25,"email":44},{"type":33,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Athena Philis-Tsimikas","Corporate Vice President",[65],{"name":66,"class":67},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100434186","phase-2-act1vate-addressing-emotional-distress-to-improve-outcomes-among-diverse-adults-with-type-1-diabetes-100434186",false,"NCT04933851","ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes","Inclusion Criteria:\n\n* Spanish or English-speaking\n* Type 1 diabetes\n* Glycosylated Hemoglobin (HbA1c) 7.0% - 12.5% in last 90 days\n* Screen positive for diabetes distress\n\nExclusion Criteria:\n\n* Severe medical or psychological conditions that would interfere with participation based on the opinion of a provider\n* Plans to move out of the San Diego area in the next 12 months\n* Lack of technology capability required to complete online surveys and telemedicine visit","ALL","18 Years",{"count":77,"type":78},250,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","This research will compare a psychological intervention (\"ACT1VATE\") versus diabetes self-management education and support (DSME\u002FS; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.",[84],"Type 1 Diabetes",[84,86],"Emotional Distress","2026-05-27",{"date":89,"type":90},"2026-05-29","ACTUAL",{"date":92,"type":90},"2021-10-25",{"date":94,"type":78},"2027-03-31",{"name":5,"class":6},1]