Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany
NCT ID: NCT06018272
Last Updated: 2024-05-10
Study Results
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Basic Information
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RECRUITING
NA
304 participants
INTERVENTIONAL
2024-02-28
2028-03-31
Brief Summary
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Study Design/ Study Population/ 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.
Clinical 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mentalization-Based Treatment (MBT)
Mentalization-Based Treatment (MBT)
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.
Bona-Fide Treatment in Germany (BFT)
Bona-Fide Treatment in Germany (BFT)
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 (\<24 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.
Interventions
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Mentalization-Based Treatment (MBT)
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.
Bona-Fide Treatment in Germany (BFT)
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 (\<24 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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* diagnosis of schizophrenia or schizotypal personality disorder
* bipolar I disorder (DSM-5)
* cognitive impairment (IQ\<80) or evidence of organic brain disorder
* BMI\<16.5
* serious medical condition that will require hospitalization within the next year (e.g. cancer)
* no sufficient German language abilities
18 Years
65 Years
ALL
No
Sponsors
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German Research Foundation
OTHER
University Düsseldorf
OTHER
Jena University Hospital
OTHER
Universitätsklinikum Ulm
UNKNOWN
Psychologische Hochschule Berlin
UNKNOWN
Heidelberg University
OTHER
Responsible Party
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Svenja Taubner
Prof. Dr. phil. Svenja Taubner
Principal Investigators
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Svenja Taubner
Role: PRINCIPAL_INVESTIGATOR
University Heidelberg
Locations
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Psychologische Hochschule Berlin
Berlin, , Germany
Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Düsseldorf
Düsseldorf, , Germany
Heidelberg University
Heidelberg, , Germany
Institute for Psychosocial Medicine, Psychotherapy and Psychooncology
Jena, , Germany
Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm
Ulm, , Germany
Countries
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Central Contacts
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Facility Contacts
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Timo Storck, Prof.
Role: primary
Anna-Maria Weiland, M. Sc.
Role: backup
Ulrike Dinger-Ehrenthal, Prof.
Role: primary
Jörg Rademacher, PD
Role: backup
Bernhard Strauss, Prof.
Role: primary
Alisa Harthaus, M. Sc.
Role: backup
Volkert Jana, Prof.
Role: primary
References
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Other Identifiers
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500412881
Identifier Type: -
Identifier Source: org_study_id
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