[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566748":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":57,"collaborators":59,"id":62,"slug":25,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Oulu University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mentalisation-Based Therapy","EXPERIMENTAL","MBT is conducted according to the treatment manual developed by Bateman \\& Fonagy. Patients are offered weekly individual sessions with an MBT therapist for 12 months.",[13],"Behavioral: Mentalisation-Based Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment as usual","ACTIVE_COMPARATOR","The TAU group will receive treatment as usual, which in mental health services might include medication, supportive counseling, short therapy, and other limited psychotherapeutic treatments such as DKT. There is no requirement for a frequency of visits for the usual psychiatric care of the TAU group, as this would not be realistic in the current service system.",[19],"Other: Treatment as Usual (TAU)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","MBT is conducted according to the treatment manual developed by Bateman \\& Fonagy. Patients are offered weekly individual sessions with an MBT therapist for 12 months.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Treatment as Usual (TAU)","The TAU group will receive treatment as usual, which in mental health services might include medication, supportive counseling, short therapy, and other limited psychotherapeutic treatments such as DKT. There is no requirement for a frequency of visits for the usual psychiatric care of the TAU group, as this would not be realistic in the current service system, and the usual treatment would not be the usual treatment currently provided.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Jenni Vähä, MSc","CONTACT","800-555-5555","jenni.vaha@pohde.fi",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":25,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University Hospital of Oulu","RECRUITING","Oulu","Finland",{"type":43,"coordinates":44},"Point",[45,46],25.46816,65.01236,{"lat":46,"lon":45},[49,51,55],{"name":32,"role":33,"phone":50,"phoneExt":25,"email":35},"+358 50 479 2161",{"name":52,"role":33,"phone":53,"phoneExt":25,"email":54},"Erika Jääskeläinen, MD, PhD","+358407191146","erika.jaaskelainen@oulu.fi",{"name":52,"role":56,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[60],{"name":61,"class":6},"University of Oulu","100566748",false,"NCT06659211","Effectiveness of Mentalization-based Therapy (MBT)","Effectiveness of Mentalization-based Therapy (MBT) as Part of a Stepped Mental Health Care in Finland - a Pilot Study","Inclusion Criteria:\n\nMBT Group:\n\n* Age 18-64 years.\n* Severe psychological symptoms, decreased functioning ability for long-term\n* Challenges with interpersonal relationships and emotional regulation\n* Patients willing to receive MBT\n* At least two of the following:\n\n  * Depression (diagnosis codes: F31.3-F31.5, F32.0-F32.9, F33.3-F33.9, F34.1) or anxiety disorder (diagnosis codes: F40-F48)\n  * Trauma background either as diagnosis or as need for treatment\n  * Signs of personality disorder (suspected or diagnosed)\n\nTAU group:\n\n* Age 18-64 years.\n* Severe psychological symptoms, decreased functioning ability for long-term\n* Challenges with interpersonal relationships and emotional regulation\n* At least two of the following\n\n  * Depression (diagnosis codes: F31.3-F31.5, F32.0-F32.9, F33.3-F33.9, F34.1) or anxiety disorder (diagnosis codes: F40-F48)\n  * Trauma background either as diagnosis or as need for treatment\n  * Signs of personality disorder (suspected or diagnosed)\n\nExclusion Criteria:\n\nMBT Group:\n\n* Active substance use disorder (i.e., intoxication F1x.0, active dependence F1x.24, Continuous use F1x.25), a physiological withdrawal state F1x.3 and F1x.4, or psychotic disorder F1x.5).\n* Acute psychosis (defined as the recent onset of severe psychotic symptoms that interfere with functioning and are not yet in a therapeutic state. Non-acute psychotic symptoms are not exclusionary)\n* Disorder requiring inpatient treatment\n* Previously received MBT\n* Currently receiving psychotherapeutic treatment (previous psychotherapeutic treatment is not an exclusion)\n\nThe exclusion criteria, therefore, do not exclude psychotic disorders or any other psychiatric illness (except substance abuse disorders).\n\nTAU group:\n\n* Active substance use disorder (i.e., intoxication F1x.0, active dependence F1x.24, Continuous use F1x.25), a physiological withdrawal state F1x.3 and F1x.4, or psychotic disorder F1x.5).\n* Acute psychosis (defined as the recent onset of severe psychotic symptoms that interfere with functioning and are not yet in a therapeutic state. Non-acute psychotic symptoms are not exclusionary)\n* Disorder requiring inpatient treatment\n* Previously received MBT\n* Intensive psychotherapy (e.g. rehabilitative psychotherapy or similar weekly long-term psychotherapy)","ALL","18 Years","64 Years",{"count":72,"type":73},128,"ESTIMATED","INTERVENTIONAL",[76],"NA","The effects of psychological treatment, mentalization-based therapy, will be studied among persons with mental disorders seeking help from mental health care services.",[79],"Severe Mental Illness",[81],"mentalization, MBT, severe mental disorder, therapy, psychotherapeutic","2025-04-22",{"date":84,"type":85},"2025-04-25","ACTUAL",{"date":87,"type":85},"2024-09-25",{"date":89,"type":73},"2026-06-30",{"name":5,"class":6},1]