[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517494":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":109,"collaborators":111,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":11,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":11,"overallStatus":44,"whyStopped":11,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Heidelberg University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mentalization-Based Treatment (MBT)","EXPERIMENTAL",null,[13],"Behavioral: Mentalization-Based Treatment (MBT)",{"label":15,"type":16,"description":11,"interventionNames":17},"Bona-Fide Treatment in Germany (BFT)","ACTIVE_COMPARATOR",[18],"Behavioral: Bona-Fide Treatment in Germany (BFT)",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"BEHAVIORAL","Patients in MBT will receive a maximum of 58 sessions in total. Of those, 30 are weekly individual sessions. 28 sessions are weekly group sessions conducted by two therapists, and consisting of 8 introductory sessions of group psychoeducation followed by 20 group therapy sessions. The duration of MBT is 12 months. MBT is manualized and relies on validating the emotional experience of patients that aims to promote mentalizing. The proposed mechanism of change in MBT is to stabilize mentalizing in certain focus areas in order to create a psychic buffer between affect and behaviour to foster affect regulation, reduce impulsivity and promote functional supportive relationships.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Patients in BFT will receive one to two weekly sessions of Bona-Fide-Treatment (Psychodynamic Therapy, PT, or Cognitive Behavioural Therapy, CBT) conducted by community experts delivered as short-term psychotherapy (\\\u003C24 sessions) or long-term psychotherapy (\\>24 sessions). BFT can be delivered as individual, group or a combination of individual and group treatment as stated in the German psychotherapy regulations.",[15],[28],{"name":29,"affiliation":30,"role":31},"Svenja Taubner","University Heidelberg","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Svenja Taubner, Prof.","CONTACT","+496221564701","svenja.taubner@med.uni-heidelberg.de",{"name":39,"role":35,"phone":11,"phoneExt":11,"email":40},"Sophie Hauschild, Dr.","sophie.hauschild@med.uni-heidelberg.de",[42,59,73,85,98],{"facility":43,"status":44,"city":45,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Psychologische Hochschule Berlin","RECRUITING","Berlin","Germany","DE",{"type":49,"coordinates":50},"Point",[51,52],13.41053,52.52437,{"lat":52,"lon":51},[55,57],{"name":56,"role":35,"phone":11,"phoneExt":11,"email":11},"Timo Storck, Prof.",{"name":58,"role":35,"phone":11,"phoneExt":11,"email":11},"Anna-Maria Weiland, M. Sc.",{"facility":60,"status":61,"city":62,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Düsseldorf","NOT_YET_RECRUITING","Düsseldorf",{"type":49,"coordinates":64},[65,66],6.77927,51.22319,{"lat":66,"lon":65},[69,71],{"name":70,"role":35,"phone":11,"phoneExt":11,"email":11},"Ulrike Dinger-Ehrenthal, Prof.",{"name":72,"role":35,"phone":11,"phoneExt":11,"email":11},"Jörg Rademacher, PD",{"facility":5,"status":44,"city":74,"state":11,"zip":75,"country":46,"countryCode":47,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Heidelberg","69115",{"type":49,"coordinates":77},[78,79],8.69079,49.40768,{"lat":79,"lon":78},[82,84],{"name":34,"role":35,"phone":11,"phoneExt":11,"email":83},"Svenja.Taubner@med.uni-heidelberg.de",{"name":39,"role":35,"phone":11,"phoneExt":11,"email":40},{"facility":86,"status":61,"city":87,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Institute for Psychosocial Medicine, Psychotherapy and Psychooncology","Jena",{"type":49,"coordinates":89},[90,91],11.5899,50.92878,{"lat":91,"lon":90},[94,96],{"name":95,"role":35,"phone":11,"phoneExt":11,"email":11},"Bernhard Strauss, Prof.",{"name":97,"role":35,"phone":11,"phoneExt":11,"email":11},"Alisa Harthaus, M. Sc.",{"facility":99,"status":61,"city":100,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm","Ulm",{"type":49,"coordinates":102},[103,104],9.99155,48.39841,{"lat":104,"lon":103},[107],{"name":108,"role":35,"phone":11,"phoneExt":11,"email":11},"Volkert Jana, Prof.",{"type":31,"investigatorFullName":29,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Prof. Dr. phil. Svenja Taubner",[112,114,116,118,121],{"name":113,"class":6},"German Research Foundation",{"name":115,"class":6},"University Düsseldorf",{"name":117,"class":6},"Jena University Hospital",{"name":119,"class":120},"Universitätsklinikum Ulm","UNKNOWN",{"name":43,"class":120},"100517494","mentalization-based-treatment-versus-bona-fide-treatment-for-patients-with-borderline-personality-disorder-in-germany-100517494",false,"NCT06018272","Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany","Mentalisierungsbasierte Therapie Versus Bona-fide-Therapie für Patient:Innen Mit Borderline-Persönlichkeitsstörung in Deutschland (MaGnet): Eine Prospektive, Multizentrische Randomisiert-kontrollierte Studie Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany (MAGNET): a Prospective, Multi-centre Randomized Controlled Trial","MAGNET","Inclusion Criteria:\n\n* Borderline Personality Disorder\n* non-suicidal self injury or suicide attempts in the past two years as indicated by the IPDE item \"repeated suicidal behaviours, gestures, threats or self-harm\", one of which has occurred in the past six months\n\nExclusion Criteria:\n\n* acute substance use disorder (exception: cannabis dependency)\n* diagnosis of schizophrenia or schizotypal personality disorder\n* bipolar I disorder (DSM-5)\n* cognitive impairment (IQ\\\u003C80) or evidence of organic brain disorder\n* BMI\\\u003C16.5\n* serious medical condition that will require hospitalization within the next year (e.g. cancer)\n* no sufficient German language abilities","ALL","18 Years","65 Years",{"count":134,"type":135},304,"ESTIMATED","INTERVENTIONAL",[138],"NA","Background: Borderline Personality Disorder (BPD) is a serious mental disorder. Mentalization-based treatment (MBT) is one evidence-based treatment for individuals with BPD. Specifically, MBT has been highlighted for its effectiveness in reduction of suicidal and non-suicidal self-injury (NSSI). Yet, randomized-controlled trials (RCT) on MBT in outpatient settings compared with bona fide treatment (BFT) are still scarce and none has been conducted in Germany. The primary objective of this RCT is to investigate whether outpatient MBT is more effective in the reduction of crisis events (incidences of NSSI and suicide attempts) compared with BFT (namely psychodynamic or cognitive-behavioural psychotherapy) in Germany. Secondary, MBT's efficacy will be investigated with regard to cost-effectiveness, general and interpersonal functioning, BPD and general symptom severity, social adjustment, quality of life, reduction in psychotropic medication and therapy retention. Additionally, moderator as well as common and treatment specific mediator variables will be investigated.\n\nStudy Design\u002F Study Population\u002F Methods: Across 5 study sites in Germany, 304 individuals of all genders from age 18 to 65 with a BPD diagnosis and NSSI or suicide attempts in the past will be asked to participate in the study for two years. In the first year, patients will receive either MBT or BFT (psychodynamic or cognitive behavioural psychotherapy) and will take part in continuous scientific assessments. Scientific assessments will continue after therapy completion up to a 12-moth follow up. As primary outcome, crisis events will be assessed via ecological momentary assessment (EMA) four times a week once per month during the first year and once every three months in the second year. Number of crisis events up to 2 years post randomization will be compared between treatment arms using a log-linear regression model following an intention-to-treat approach. Secondary outcomes, such as borderline and general symptom severity, will be assessed at several timepoints. A within-trial cost-effectiveness analysis (CEA) will be conducted with a societal perspective.\n\nClinical Trial Rationale: This study investigates efficacy of MBT as BPD specific treatment in an outpatient setting compared with BFT in Germany. Results of this study can address a treatment gap in the German healthcare system, and inform about health economic aspects of BPD treatment as well as mechanisms of psychotherapeutic change.",[141],"Borderline Personality Disorder","2024-05-08",{"date":144,"type":145},"2024-05-10","ACTUAL",{"date":147,"type":145},"2024-02-28",{"date":149,"type":135},"2028-03-31",{"name":5,"class":6},5]