[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576752":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":52,"locations":58,"responsibleParty":131,"collaborators":133,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":147,"sex":153,"minAge":154,"maxAge":34,"enrollmentInfo":155,"targetDuration":34,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":61,"whyStopped":34,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"Arkin","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Specialist Treatment for Severe Personality Disorders","ACTIVE_COMPARATOR","Participants will receive specialist treatment for severe personality disorders. Specifically, the type of treatment will be either mentalization-based treatment (MBT) or schema therapy (ST), depending on local availbility, treatment history and shared-decision making. Both MBT and ST must adhere to the protocol and minimum dosage described in respective effect studies published on MBT or ST.",[13,14],"Behavioral: Schema therapy","Behavioral: Mentalization-based treatment",{"label":16,"type":17,"description":18,"interventionNames":19},"Generalist Treatment for Severe Personality Disorders","EXPERIMENTAL","Participants will receive a generalist treatment for severe personality disorders. Specificially, the Guideline-Informed Treatment for Personality Disorders (GIT-PD). Sites can only participate in this study, if they offer a GIT-PD programme of lower dosage than the specialist intervention offered at the same site.",[20],"Behavioral: Guideline-informed treatment for personality disorders",[22,30,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","Schema therapy","Schema therapy (ST) is an evidence-based, fully manualized, specialist form of psychotherapy for personality disorders (Bamelis et al., 2014; Sempértegui et al., 2013; Arntz et al., 2022). Eligible programs must adhere to the minimum standards described in the evidence-based literature. ST is an integrative treatment method, originally rooted in cognitive theory, but with additional influences from Gestalt, psychodynamic, and experiential methods. Schema therapy programs may differ in intensity and duration, even at the same site, but must include a minimum of either 40 sessions and\u002For a duration of 12 to 24 months. In addition, in order to be eligible, a schema therapy program must be of higher intensity or longer duration than the generalist treatment (GIT-PD) offered at the same site.",[9],[28,29],"Schema-focused therapy","SFT",{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Mentalization-based treatment","Mentalization-based treatment (MBT) is an evidence-based, fully manualized, specialist form of psychotherapy for personality disorders (Bateman \\& Fonagy, 2008; Bateman \\& Fonagy, 2009; Laurenssen et al., 2018; Juul et al., 2023). MBT is rooted in psychodynamic and attachment theory and aims to alter personality pathology by improving mentalizing and enhancing epistemic trust. Eligible programs must adhere to the minimum standards described in the evidence-based literature. MBT programs may differ in intensity and duration, even at the same site, but must include a minimum of either 40 sessions or a duration of 12 to 24 months. In additon, in order to be eligible, an MBT program must be of higher intensity or longer duration than the generalist treatment (GIT-PD) offered at the same site.",[9],null,{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Guideline-informed treatment for personality disorders","GIT-PD is a non-theoretical and non-methodological approach, based upon principles derived from common factors across evidence-based treatments for PD. GIT-PD has a flexible approach, enabling tailoring treatment to clinical needs of different types of patients. The treatment duration (start-end) is 12- 18 months. The treatment consists of three distinct phases. First, an assessment phase. Second, a modular treatment phase that offers either group or individual interventions. Third, a follow-up phase with limited treatment and focus on relapse prevention. In order to be eligible, GIT-PD should be less intensive than specialist psychotherapies offered in the control arm at the same location (i.e. MBT or ST). GIT-PD will not include evidence-based psychotherapy for personality disorders as described in previous RCTs.",[16],[40,44,48],{"name":41,"affiliation":42,"role":43},"Henricus L. Van, Dr.","Arkin NPI","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":46,"role":47},"Joost Hutsebaut, Prof. dr.","Tilburg University; GGZ de Viersprong","STUDY_DIRECTOR",{"name":49,"affiliation":50,"role":51},"Nathan Bachrach, Dr.","Tilburg University; GGZ Oost-Brabant","STUDY_CHAIR",[53],{"name":54,"role":55,"phone":56,"phoneExt":34,"email":57},"Jan Philipp Löffler, MSc","CONTACT","+31-020-590-4700","J.P.Loffler@tilburguniversity.edu",[59,76,88,102,116],{"facility":60,"status":61,"city":62,"state":63,"zip":34,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"GGZ de Viersprong","RECRUITING","Halsteren","North Brabant","Netherlands","NL",{"type":67,"coordinates":68},"Point",[69,70],4.26785,51.52834,{"lat":70,"lon":69},[73],{"name":45,"role":55,"phone":74,"phoneExt":34,"email":75},"+31-088-656-216","Klantburo@deviersprong.nl",{"facility":77,"status":61,"city":78,"state":63,"zip":34,"country":64,"countryCode":65,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"GGZ Oost-Brabant","Helmond",{"type":67,"coordinates":80},[81,82],5.66111,51.48167,{"lat":82,"lon":81},[85],{"name":49,"role":55,"phone":86,"phoneExt":34,"email":87},"+31-088-846-04-60","communicatie@ggzoostbrabant.nl",{"facility":42,"status":61,"city":89,"state":90,"zip":91,"country":64,"countryCode":65,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Amsterdam","North Holland","1033NN",{"type":67,"coordinates":93},[94,95],4.88969,52.37403,{"lat":95,"lon":94},[98,100],{"name":54,"role":55,"phone":56,"phoneExt":34,"email":99},"j.p.loffler@tilburguniversity.edu",{"name":101,"role":43,"phone":34,"phoneExt":34,"email":34},"Henricus L. Van, Dr. phil.",{"facility":103,"status":61,"city":104,"state":105,"zip":34,"country":64,"countryCode":65,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Dimence Group","Almelo","Overijssel",{"type":67,"coordinates":107},[108,109],6.6625,52.35667,{"lat":109,"lon":108},[112],{"name":113,"role":55,"phone":114,"phoneExt":34,"email":115},"Maarten van Dijk, Dr.","+31-0570-639-600","persvoorlichting@dimencegroep.nl",{"facility":117,"status":118,"city":119,"state":120,"zip":34,"country":64,"countryCode":65,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Altrecht","NOT_YET_RECRUITING","Zeist","Utrecht",{"type":67,"coordinates":122},[123,124],5.23333,52.09,{"lat":124,"lon":123},[127],{"name":128,"role":55,"phone":129,"phoneExt":34,"email":130},"Maarten van Westen, Dr.","+31-030-696-5100","altrechtstart@altrecht.nl",{"type":132,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[134,136,139,141,143],{"name":60,"class":135},"UNKNOWN",{"name":137,"class":138},"Ggz Oost Brabant","OTHER",{"name":140,"class":135},"Stichting Altrecht GGZ",{"name":142,"class":135},"Stichting Dimence Group",{"name":144,"class":138},"Tilburg University","100576752","the-cost-effectiveness-of-generalist-versus-specialist-treatment-for-severe-personality-disorders-100576752",false,"NCT06789380","The (Cost-)Effectiveness of Generalist Versus Specialist Treatment for Severe Personality Disorders'","The (Cost-)Effectiveness of Generalist (GIT-PD) Versus Specialist Treatment (MBT\u002FST) for Severe Personality Disorders (the P-DAET Study): a Pragmatic Randomized Controlled Non-Inferiority Trial.'","P-DAET","Inclusion Criteria:\n\n* 'severe' or 'extreme' personality disorder (PD) according to the alternative model for PDs\n\nExclusion Criteria:\n\n* IQ \\\u003C 75\n* legal incapacity\n* Any mental state disorder that requires prior treatment","ALL","18 Years",{"count":156,"type":157},358,"ESTIMATED","INTERVENTIONAL",[160],"NA","The goal of this clinical trial is to investigate if generalist treatment (GIT-PD) is non-inferior in improving level op personality functioning compared to specialist treatment (MBT\u002FST) in patients with severe personality disorders. The main questions it aims to answer are:\n\n1. Is generalist treatment (GIT-PD) non-inferior in improving level of personality functioning compared to specialist treatment (MBT\u002FST) in patients suffering from severe personality disorders (PD)?\n2. What patient characteristics predict which patients will benefit more from specialist or generalist treatment?\n\nParticipants will be randomized to either specialist or generalist treatment. Interventions included in specialist treatment are Mentalization-Based Treatment (MBT) and Schema Therapy (ST). Generalist treatment will be offererd following the principles of the Guideline-Informed Treatment for Personality Disorders (GIT-PD), a principle-driven treatment framework based upon common factors and allowing personalized treatment according to patients' needs. All participating institutions offer GIT-PD and MBT and\u002For ST. Before, during and after following this treatment participants will complete measurements at 8 distinct time points.\n\nParticipants will be asked to:\n\n* complete a range of instruments at baseline to enable the construction of a personalized advantage index to predict treatment response based on patient characteristics\n* complete questionnaires at all 7 post-randomization time points\n* undergo a semi-structured interview at 3 time points\n* follow treatment for personality disorders (either GIT-PD or MBT\u002FST)",[163],"Severe Personality Disorder",[165,166,167,168,169,170,171,172,173,174,175,176],"generalist psychotherapy","specialist psychotherapy","personality disorder","AMPD","schema therapy","mentalisation-based treatment","guideline-informed treatment for personality disorders","level of personality functioning","alternative model of personality disorders","GIT-PD","MBT","ST","2025-02-03",{"date":179,"type":180},"2025-02-05","ACTUAL",{"date":182,"type":180},"2024-10-21",{"date":184,"type":157},"2028-12",{"name":5,"class":6},5]