[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588045":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":11,"locations":24,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":21,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":11,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":27,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention at t0","EXPERIMENTAL",null,[13],"Behavioral: ACTnow",{"label":15,"type":10,"description":16,"interventionNames":17},"wait list control group","Control group for the first 3 months, whereafter the arm will receive the same intervention as arm 1",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"BEHAVIORAL","ACTnow","The group-based psychological intervention consists of six bi-weekly sessions, each lasting two hours, with 6-10 participants per group, led by a psychologist and nurse.\n\nThe intervention is based on Acceptance and Commitment Therapy (ACT), an evidence-based approach shown to be effective for chronic diseases, with additional elements from cognitive behavioral therapy and health education. It is manual-based, developed by experienced clinicians at SDCO, and includes tools from an existing diabetes distress intervention (REDUCE).\n\nEach session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion. Participants complete an online questionnaire to track diabetes distress after each session. The group process lasts about 3 months. Preliminary results from a feasibility study showed positive outcomes in recruitment, patient satisfaction, and reduction of diabetes distress (publication in progress).",[9,15],[25,43,53],{"facility":26,"status":27,"city":28,"state":11,"zip":11,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Esbjerg Hospital","RECRUITING","Esbjerg","Denmark","DK",{"type":32,"coordinates":33},"Point",[34,35],8.45187,55.47028,{"lat":35,"lon":34},[38],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Claus Bogh Juhl","CONTACT","+45 79183120","claus.bogh.juhl@rsyd.dk",{"facility":5,"status":27,"city":44,"state":11,"zip":11,"country":29,"countryCode":30,"cosmosGeoPoint":45,"geoPoint":49,"contacts":50},"Odense",{"type":32,"coordinates":46},[47,48],10.38831,55.39594,{"lat":48,"lon":47},[51],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":52},"claus.bogh.juhk@rsyd.dk",{"facility":54,"status":27,"city":55,"state":11,"zip":11,"country":29,"countryCode":30,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Sønderborg Hospital","Sønderborg",{"type":32,"coordinates":57},[58,59],9.78917,54.90896,{"lat":59,"lon":58},[62],{"name":63,"role":40,"phone":64,"phoneExt":11,"email":65},"Frans Brandt Kristensen","+45 79973010","FBK@rsyd.dk",{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[69],{"name":70,"class":6},"Steno Diabetes Center Odense","100588045","type-1-diabetes-and-diabetes-distress-100588045",false,"NCT06936280","Type 1 Diabetes and Diabetes Distress","A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress","Inclusion Criteria:\n\n* Type 1 diabetes for at least 6 months\n* Age between 18 and 35\n* T1-DDS score ≥ 2, or T1-DDS subscale score ≥ 2\n* Treated in a diabetes clinic in the Region of Southern Denmark\n* Proficient in Danish\n\nExclusion Criteria:\n\n* Psychiatric diagnosis: diagnosed with substance abuse, alcohol abuse, psychosis, schizophrenia or any other psychiatric diagnosis that may compromise participation in the intervention\n* Cognitive disorders such as brain injury\n* Complex challenges best suited to individual treatment\n* Current therapeutic treatment for depression, anxiety or stress\n* Not stable medication for anxiety\u002Fdepression for the past two months or planned change in medication for anxiety\u002Fdepression during the project period","ALL","18 Years","35 Years",{"count":82,"type":83},100,"ESTIMATED","INTERVENTIONAL",[86],"NA","The goal of this clinical trial is to reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress.\n\nThe expectation is that a group-based psychological intervention (ACTnow) will not only reduce diabetes distress but also improve psychological well-being and glycemic outcomes.\n\nThe intervention involves a multidisciplinary team, including nurses, psychologists, and physicians, and is designed in a format that can easily be integrated into future standard care.\n\nThe main research questions are:\n\n* Does a group-based psychological intervention reduce diabetes distress?\n* Does a group-based psychological intervention improve psychological well-being and glycemic outcomes?\n\nResearchers will compare the group-based psychological intervention (arm 1) with a waitlist control group, which will receive the intervention after three months (arm 2).\n\nParticipants will first attend a virtual screening interview with a psychologist or nurse to identify if they are eligible to participate in the study. After randomization, the intervention group receives six bi-weekly sessions, each lasting two hours, led by a psychologist and nurse. Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion.",[89,90],"Diabetes Distress","Diabetes Mellitus Type 1",[92,93,94,21],"RCT study","type 1 diabetes","diabetes distress","2026-04-08",{"date":97,"type":98},"2026-04-09","ACTUAL",{"date":100,"type":98},"2025-04-01",{"date":102,"type":83},"2027-05-31",{"name":5,"class":6},3]