[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559387":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":65,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":31,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":31,"enrollmentInfo":80,"targetDuration":31,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University Hospital Bispebjerg and Frederiksberg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment as usual (TAU)","ACTIVE_COMPARATOR","Patients with BPD are offered group-based treatment and individual therapy according to the standardized healthcare delivery models, known as the \"psychiatric treatment package\" for borderline personality disorder. The treatment package complies with the description agreed upon in common documents endorsed by all Danish Regions. The content of the treatment package includes psychotherapeutic treatment, according to the evidence based diagnose-specific manuals, and consultations with a psychiatrist. In this study this specifically includes, a treatment program consisting of dialectic behavioral treatment (DBT), delivered according to the manuals by Linehan, 1993 and Linehan, 2015.",[13],"Other: Treatment as usual",{"label":15,"type":16,"description":17,"interventionNames":18},"The experimental intervention PEGASUS","EXPERIMENTAL","Patients in PEGASUS will, in addition to TAU, be offered to be affiliated with a case manager and to have their families involved in family-based interventions. Duration of the intervention will be nine months.\n\nThe case manager will be a trained professional, who will be able to be a guiding figure and when needed, be able to help the patient contacting different authorities. The case manager can support the patient in solving everyday life problems, and will be an occupational therapist, a nurse, or a social worker. The case manager will offer the patients nine extra individual sessions during their treatment course.\n\nThe format of the family-based interventions will be two psychoeducational workshops with 6 to 8 families invited and six multifamily group meetings, in which the patient and one or two relatives can participate. Theories behind Psychoeducational Multifamily Groups, Compassion Cultivation Training and Family Connections (FC, Hoffman et al., 2007) will be drawn upon.",[19],"Other: The experimental intervention PEGASUS",[21,27],{"type":6,"name":15,"description":22,"armGroupLabels":23,"otherNames":24},"See arm description.",[15],[25,26],"Case Manager","Family-based interventions",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Treatment as usual","See arm description",[9],null,[33],{"name":34,"affiliation":35,"role":36},"Carsten Hjorthøj, Ph.d.","Copenhagen Research Center for Mental Health","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},"Ditte H. Rotvig, MD","CONTACT","+45 31154887","ditte.hoeyer.rotvig@regionh.dk",{"name":34,"role":40,"phone":44,"phoneExt":31,"email":45},"+45 26136290","carsten.hjorthoej@regionh.dk",[47],{"facility":48,"status":49,"city":50,"state":31,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Copenhagen Research Center for Mental Health - CORE","RECRUITING","Copenhagen","2900","Denmark","DK",{"type":55,"coordinates":56},"Point",[57,58],12.56553,55.67594,{"lat":58,"lon":57},[61,62,64],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},{"name":31,"role":40,"phone":31,"phoneExt":31,"email":63},"merete.nordentoft@regionh.dk",{"name":34,"role":36,"phone":31,"phoneExt":31,"email":31},{"type":36,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Carsten Hjorthøj","Associate Professor",[69],{"name":70,"class":6},"Hvidovre University Hospital","100559387","pegasus---improving-treatment-for-patients-with-emotionally-unstable-personality-disorder-100559387",false,"NCT06563466","PEGASUS - Improving Treatment for Patients With Emotionally Unstable Personality Disorder","Participating Patients\n\nInclusion Criteria:\n\n* Must be able to give an informed written consent.\n* Must be newly accepted in the pre-planned BPD treatment packages.\n* ≥18 years of age.\n* Agreeing to involvement of one or two informal caregivers, families, or close friends (\"Relatives\").\n* Capable of reading and understanding Danish.\n\nExclusion Criteria:\n\n* None\\*\n\n  * Note that to get accepted into a treatment package for BPD, patients must not fulfill the criteria for a F20 diagnosis or the criteria for alcohol or substance abuse or harmful use.\n\nParticipating Relatives:\n\nInclusion Criteria:\n\n* Must be able to give an informed written consent.\n* ≥18 years of age.\n* Capable of reading and understanding Danish.\n\nExclusion criteria: None",true,"ALL","18 Years",{"count":81,"type":82},100,"ESTIMATED","INTERVENTIONAL",[85],"NA","The purpose of the PEGASUS study is to conduct a pilot trial to test the feasibility and acceptability of the PEGASUS intervention, adding a case manager and family-based interventions meetings to the existing psychiatric integrated care-models known as \"Treatment Packages\" in Denmark. We will conduct a randomized, assessor-blinded parallel-groups superiority clinical trial, testing the PEGASUS intervention for emotionally unstable personality disorder \"EUPD\", borderline type (borderline personality disorder) compared to \"Treatment as Usual\" before moving on to testing in a full-scale trial. Participants will be assessed at baseline and 9 month post baseline at study conclusion",[88,89],"Borderline Personality Disorder","Relatives",[88,89,91,92,93,94,95],"Group psychotherapy","Case management","Psychoeducation","Family","Caregiver","2026-04-22",{"date":98,"type":99},"2026-04-28","ACTUAL",{"date":101,"type":99},"2024-09-01",{"date":103,"type":82},"2029-08-31",{"name":5,"class":6},1]