[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588045":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":11,"locations":24,"responsibleParty":65,"collaborators":67,"id":70,"slug":11,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":21,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":27,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"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],[25,42,52],{"facility":26,"status":27,"city":28,"state":11,"zip":11,"country":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Esbjerg Hospital","RECRUITING","Esbjerg","Denmark",{"type":31,"coordinates":32},"Point",[33,34],8.45187,55.47028,{"lat":34,"lon":33},[37],{"name":38,"role":39,"phone":40,"phoneExt":11,"email":41},"Claus Bogh Juhl","CONTACT","+45 79183120","claus.bogh.juhl@rsyd.dk",{"facility":5,"status":27,"city":43,"state":11,"zip":11,"country":29,"cosmosGeoPoint":44,"geoPoint":48,"contacts":49},"Odense",{"type":31,"coordinates":45},[46,47],10.38831,55.39594,{"lat":47,"lon":46},[50],{"name":38,"role":39,"phone":40,"phoneExt":11,"email":51},"claus.bogh.juhk@rsyd.dk",{"facility":53,"status":27,"city":54,"state":11,"zip":11,"country":29,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Sønderborg Hospital","Sønderborg",{"type":31,"coordinates":56},[57,58],9.78917,54.90896,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":63,"phoneExt":11,"email":64},"Frans Brandt Kristensen","+45 79973010","FBK@rsyd.dk",{"type":66,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[68],{"name":69,"class":6},"Steno Diabetes Center Odense","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":80,"type":81},100,"ESTIMATED","INTERVENTIONAL",[84],"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.",[87,88],"Diabetes Distress","Diabetes Mellitus Type 1",[90,91,92,21],"RCT study","type 1 diabetes","diabetes distress","2026-04-08",{"date":95,"type":96},"2026-04-09","ACTUAL",{"date":98,"type":96},"2025-04-01",{"date":100,"type":81},"2027-05-31",{"name":5,"class":6},3]