[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600144":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":27,"locations":33,"responsibleParty":50,"collaborators":12,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":12,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":36,"whyStopped":12,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Vaudois","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"NBCI","NO_INTERVENTION","Control intervention will consist of Need-Based Clinical Intervention (NBCI). NBCI reflects routine, community-based mental health services as delivered in real-world clinical settings. NBCI are not protocol-driven or manualized. Instead, following a structured baseline assessment of risk and clinical needs, treatment recommendations are formulated in accordance with internationally recognized clinical guidelines. A referral mental health professional, not involved in this study, is expected to conduct an initial assessment of each patient's personal needs.\n\nThese interventions will be tailored according to these needs which will determine the type of treatments and theirs frequencies. These interventions include a large range of treatments such as pharmacological treatment, psychotherapeutic sessions (including psychoeducation), case management, or occupational support, delivered by patient's usual therapists, who are fully qualified mental health professionals.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"MBT + NBCI","EXPERIMENTAL","Description: The MBT intervention consists of 24 weekly individual psychotherapy sessions, supplemented by monthly mentalization-based family therapy sessions spread across six phases. The individual sessions are manualized into six blocks, each comprising four weekly sessions. Each block typically begins with sessions that heavily incorporate psychoeducation and progressively transitions to a thematically guided session format. Both patient and family sessions will last 50 minutes, and may be audiotaped for quality control and intern supervision. Participants, along with their families or carers, will be informed of this procedure and retain the right to decline recording. Overall, the program is designed to improve patients' capacity to understand their own and others' mental states and, within interpersonal settings, how these patterns contribute to conflict and psychological distress.",[18],"Other: MBT + NBCI",[20],{"type":6,"name":14,"description":21,"armGroupLabels":22,"otherNames":12},"The MBT for CHR-P intervention consists of 24 weekly individual psychotherapy sessions, supplemented by monthly mentalization-based family therapy sessions. Both patient and family sessions will last 50 minutes. These psychotherapeutic sessions will complement those received though NBCI by strengthening mentalizing abilities aiming to reduce or prevent detrimental outcomes, by prohibiting or restricting some usual techniques in NBCI treatment (e.g., interpretation, cognitive challenge and Socratic dialogue) and by emphasizing certain techniques (e.g., empathic validation, active management of emotional arousal) which are only sporadically and irregularly used during NBCI treatment. Overall, the program is designed to improve patients' capacity to understand their own and others' mental states and, within interpersonal settings, how these patterns contribute to conflict and psychological distress.",[14],[24],{"name":25,"affiliation":5,"role":26},"Marco Armando, PR","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":12,"email":32},"Marco Armando, Pr","CONTACT","+41 079 556 49 46","marco.armando@chuv.ch",[34],{"facility":35,"status":36,"city":37,"state":12,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"CHUV","RECRUITING","Lausanne","1011","Switzerland","CH",{"type":42,"coordinates":43},"Point",[44,45],6.63282,46.516,{"lat":45,"lon":44},[48,49],{"name":29,"role":30,"phone":31,"phoneExt":12,"email":32},{"name":25,"role":26,"phone":12,"phoneExt":12,"email":12},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Marco Armando","PR","100600144","mentalization-based-treatment-mbt-in-help-seeking-youths-with-a-clinical-high-risk-condition-for-psychosis-chr-p-100600144",false,"NCT07093671","Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P)","Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P): a Randomized Controlled Trial","MBT-Psychosis","Inclusion Criteria:\n\n* Patients aged 14-30 years with a CHR-P condition, as defined by the SIPS criteria\n* Patients who provide informed consent\n\nExclusion Criteria:\n\n* Patients with a prior diagnosis of a psychotic disorder\n* Intellectual disability (IQ \\\u003C 70).\n* Patients whose psychotic symptoms are primarily induced by substance misuse.\n* Patients with significant language barriers\n* Parents\u002Flegal authority who do not provide informed consent (only minors)\n* Adult patient under guardianship\n\nNote: Comorbidities with other psychiatric disorders (e.g., Autism Spectrum Disorder, Personality Disorders) will not constitute an exclusion criterion.","ALL","14 Years","30 Years",{"count":66,"type":67},212,"ESTIMATED","INTERVENTIONAL",[70],"NA","The primary objective of this study is to evaluate the efficacy of Mentalization-Based Treatment (MBT) combined with Need-Based Clinical Interventions (NBCI) compared to NBCI alone, on CHR-P diagnostic statuses and symptom expression (Hypothesis 1). Specifically, the investigator will assess diagnostic outcomes using a 3-level variable: transition to psychosis, CHR-P status quo, and remission out of CHR-P, as well as CHR-P symptom expression. The investigator hypothesize that: (1a) the experimental treatment (MBT + NBCI) will have a significant effect on diagnostic status (i.e. transition to psychosis) at the end of treatment and follow-up; (1b) the experimental treatment (MBT + NBCI) will significantly reduce the severity of psychotic symptoms at the end of treatment and follow-up.",[73],"Psychosis",[73,75,76],"MBT","Mentalization-Based Treatment","2026-07-07",{"date":79,"type":80},"2026-07-08","ACTUAL",{"date":82,"type":80},"2025-08-01",{"date":84,"type":67},"2028-08-31",{"name":52,"class":6},1]