xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06018272</url>
    </required_header>
    <id_info>
      <org_study_id>500412881</org_study_id>
      <nct_id>NCT06018272</nct_id>
    </id_info>
    <brief_title>Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany</brief_title>
    <acronym>MAGNET</acronym>
    <official_title>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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Heidelberg University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>German Research Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Universitätsklinikum Düsseldorf</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Universitätsklinikum Jena</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Universitätsklinikum Ulm</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Medical School Berlin</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Heidelberg University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: Borderline Personality Disorder (BPD) is a serious mental disorder.&#xD;
        Mentalization-based treatment (MBT) is one evidence-based treatment for individuals with BPD.&#xD;
        Specifically, MBT has been highlighted for its effectiveness in reduction of suicidal and&#xD;
        non-suicidal self-injury (NSSI). Yet, randomized-controlled trials (RCT) on MBT in outpatient&#xD;
        settings compared with bona fide treatment (BFT) are still scarce and none has been conducted&#xD;
        in Germany. The primary objective of this RCT is to investigate whether outpatient MBT is&#xD;
        more effective in the reduction of crisis events (incidences of NSSI and suicide attempts)&#xD;
        compared with BFT (namely psychodynamic or cognitive-behavioural psychotherapy) in Germany.&#xD;
        Secondary, MBT's efficacy will be investigated with regard to cost-effectiveness, general and&#xD;
        interpersonal functioning, BPD and general symptom severity, social adjustment, quality of&#xD;
        life, reduction in psychotropic medication and therapy retention. Additionally, moderator as&#xD;
        well as common and treatment specific mediator variables will be investigated.&#xD;
  &#xD;
        Study Design/ Study Population/ Methods: Across 5 study sites in Germany, 304 individuals of&#xD;
        all genders from age 18 to 65 with a BPD diagnosis and NSSI or suicide attempts in the past&#xD;
        will be asked to participate in the study for two years. In the first year, patients will&#xD;
        receive either MBT or BFT (psychodynamic or cognitive behavioural psychotherapy) and will&#xD;
        take part in continuous scientific assessments. Scientific assessments will continue after&#xD;
        therapy completion up to a 12-moth follow up. As primary outcome, crisis events will be&#xD;
        assessed via ecological momentary assessment (EMA) four times a week once per month during&#xD;
        the first year and once every three months in the second year. Number of crisis events up to&#xD;
        2 years post randomization will be compared between treatment arms using a log-linear&#xD;
        regression model following an intention-to-treat approach. Secondary outcomes, such as&#xD;
        borderline and general symptom severity, will be assessed at several timepoints. A&#xD;
        within-trial cost-effectiveness analysis (CEA) will be conducted with a societal perspective.&#xD;
  &#xD;
        Clinical Trial Rationale: This study investigates efficacy of MBT as BPD specific treatment&#xD;
        in an outpatient setting compared with BFT in Germany. Results of this study can address a&#xD;
        treatment gap in the German healthcare system, and inform about health economic aspects of&#xD;
        BPD treatment as well as mechanisms of psychotherapeutic change.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>change in crisis events assessed with Ecological Momentary Assessment with items based on the SHBQ (Gutierrez et al., 2001)</measure>
      <time_frame>one week each month for 24 months OR every second day, one week per month in the first year and one week every three months in the second year</time_frame>
      <description>composite score (non)suicidal self injury</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Symptoms of Borderline Personality Disorder assessed with the IPDE (Loranger et al., 1997) and BSL-23 (Wolf et al., 2009)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24; IPDE only at Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in psychiatric symptom severity assessed with the DASS- 21 (Lovibond &amp; Lovibond, 1995)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in health and disability assessed with WHODAS 2.0 Short Form (Üstün et al., 2010)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in personality funcitioning assessed with LPFS-BF (Hutsebaut et al., 2016)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in personality traits assessed with PID5BF+M (Bach et al., 2020)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in threat hypersensitivity assessed with emotion classification task (Honecker et al., 2021)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
      <description>Participants are presented with 160 faces, each unambiguously showing one of four emotional expressions (angry, fearful, happy, neutral). The goal of the task is to correctly classify these facial expressions. The task's collected behavioral data encompasses two key measurements: the ratio of accurate responses (specifically, correct emotion classification) and the time it takes to respond in trials where the emotion classification is correct.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in quality of life assessed with EQ-5D-5L (Herdman et al., 2011; EuroQol Research Foundation, 2019)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in trait anger assessed with STAXI-2 (Spielberger, 1999)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in social adjustment assessed with WSAS (Marks, 1986)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in emotional reactions to social exclusion, rejection and relational devaluation with SPQ (Stangier et al., 2021)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Interoceptive Body Awareness with MAIA-2 (Mehling et al., 2018)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in medication with self-report of medication prescription via adapted version of AD-SUS (Kuyken et al., 2015)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heath Care utilization with an adapted version of the AD-SUS (Kuyken et al., 2015)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in acute dissociative symptoms with Dissociation-Tension Scale-4 (DSS-4; Stiglmayr et al., 2003)</measure>
      <time_frame>Day 0, Month 6, Month 12, Month 24</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Mentalizing as mediator of change assessed with the Certainty About Mental States Questionnaire (CAMSQ; Müller et al., 2021)</measure>
      <time_frame>Month 6, Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Therapeutic Agency Inventory (TAI; Huber et al., 2019)</measure>
      <time_frame>once a week in the first year and at Month 6 and Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Group Questionnaire - short (GQ; Jensen, 2016)</measure>
      <time_frame>once a week in the first year and at Month 6 and Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ; Campbell et al., 2019)</measure>
      <time_frame>Month 6, Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Experiences in Close Relationships-Revised Screening Version (ECR-RD8; Ehrenthal et al., 2021)</measure>
      <time_frame>Month 6, Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Difficulties in Emotion Regulation Scale (DERS; Gratz &amp; Roemer, 2004)</measure>
      <time_frame>Month 6, Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Mentalizing as mediator of change assessed with Mentalizing Emotions Questionnaire (Kasper et al., submitted)</measure>
      <time_frame>Month 6, Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Negative Effects Questionnaire (NEQ; Rozental et al., 2016)</measure>
      <time_frame>Month 12</time_frame>
      <description>Serious adverse events of therapy</description>
    </other_outcome>
    <other_outcome>
      <measure>Therapeutic Alliance as mediator of change assessed with Working Alliance Inventory (WAI-SR, Hatcher &amp; Gillaspy, 2006)</measure>
      <time_frame>once a week in the first year and at Month 6 and Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Symptoms of PTSD and complex PTSD and complex PTSD Trauma experiences with Internation Trauma Interview (ITI; Roberts et al., 2019)</measure>
      <time_frame>Day 0</time_frame>
      <description>Moderator</description>
    </other_outcome>
    <other_outcome>
      <measure>Symptoms of PTSD and complex PTSD with International Trauma Questionnaire (ITQ; Cloitre et al., 2018)</measure>
      <time_frame>Day 0</time_frame>
      <description>Moderator</description>
    </other_outcome>
    <other_outcome>
      <measure>Level of personality functioning with Semi-Structured Interview for Personality Functioning DSM-5 (STiP; Hutsebaut et al., 2017)</measure>
      <time_frame>Day 0</time_frame>
      <description>Moderator</description>
    </other_outcome>
    <other_outcome>
      <measure>Change of pleasure, arousal and dominance with Self-Assessment Manikin (Bradley, 1994)</measure>
      <time_frame>once a week in the first year and at Month 6 and Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Change of frequency of occurence of positive and negative automatic thoughts with Automatic Thoughts Questionnaire - Revised (ATQ-R; Kendall, 1989)</measure>
      <time_frame>Month 6, Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Assessment of the frequency of alliance ruptures and resolution processes in therapy sessions with Rupture Resolution Rating System (Eubanks et al., 2015)</measure>
      <time_frame>Month 6, Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Assessment of the clients'attachment style with the Patient Attachment Coding System (Talia &amp; Miller-Bottome, 2012)</measure>
      <time_frame>Month 6, Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Assessment of the therapists' attunement and attachment status with the Therapist Attunement Scales (Talia &amp; Muzi, 2017)</measure>
      <time_frame>Month 6, Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Assessment of the therapists' activity and appropriateness in essential domains of MBT with the Mentalization-Based Treatment Adherence and Competence Scale (Bateman &amp; Fonagy, 2016)</measure>
      <time_frame>Month 6, Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Assessment of the therapists' adherence to psychodynamic-interpersonal and cognitive-behavioural treatments with the Comparative Psychotherapy Process Scale (Hilsenroth et al., 2005)</measure>
      <time_frame>Month 6, Month 12</time_frame>
      <description>Mediator</description>
    </other_outcome>
    <other_outcome>
      <measure>Interview for treatment and study evaluation</measure>
      <time_frame>Month 24</time_frame>
      <description>Semi-structured interview developed based on Krause et al. 2016 will be used to assess how patients experienced the therapy and the study, what aspects they perceived as positive or negative, and what impact the therapy had on their symptoms and their life</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">304</enrollment>
    <condition>Borderline Personality Disorder</condition>
    <arm_group>
      <arm_group_label>Mentalization-Based Treatment (MBT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Bona-Fide Treatment in Germany (BFT)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mentalization-Based Treatment (MBT)</intervention_name>
      <description>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.</description>
      <arm_group_label>Mentalization-Based Treatment (MBT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Bona-Fide Treatment in Germany (BFT)</intervention_name>
      <description>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 (&lt;24 sessions) or long-term psychotherapy (&gt;24 sessions). BFT can be delivered as individual, group or a combination of individual and group treatment as stated in the German psychotherapy regulations.</description>
      <arm_group_label>Bona-Fide Treatment in Germany (BFT)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Borderline Personality Disorder&#xD;
  &#xD;
            -  non-suicidal self injury or suicide attempts in the past two years as indicated by the&#xD;
               IPDE item &quot;repeated suicidal behaviours, gestures, threats or self-harm&quot;, one of which&#xD;
               has occurred in the past six months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  acute substance use disorder (exception: cannabis dependency)&#xD;
  &#xD;
            -  diagnosis of schizophrenia or schizotypal personality disorder&#xD;
  &#xD;
            -  bipolar I disorder (DSM-5)&#xD;
  &#xD;
            -  cognitive impairment (IQ&lt;80) or evidence of organic brain disorder&#xD;
  &#xD;
            -  BMI&lt;16.5&#xD;
  &#xD;
            -  serious medical condition that will require hospitalization within the next year (e.g.&#xD;
               cancer)&#xD;
  &#xD;
            -  no sufficient German language abilities&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Svenja Taubner</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Heidelberg</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Svenja Taubner, Prof.</last_name>
      <phone>+496221564701</phone>
      <email>svenja.taubner@med.uni-heidelberg.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sophie Hauschild, Dr.</last_name>
      <email>sophie.hauschild@med.uni-heidelberg.de</email>
    </overall_contact_backup>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Heidelberg University</investigator_affiliation>
      <investigator_full_name>Svenja Taubner</investigator_full_name>
      <investigator_title>Prof. Dr. phil. Svenja Taubner</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Personality Disorders</mesh_term>
      <mesh_term>Borderline Personality Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06018272
  org study id: 500412881
  nct id: NCT06018272
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  
        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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: change in crisis events assessed with Ecological Momentary Assessment with items based on the SHBQ (Gutierrez et al., 2001)
  time frame: one week each month for 24 months OR every second day, one week per month in the first year and one week every three months in the second year
  description: composite score (non)suicidal self injury
  measure: Symptoms of Borderline Personality Disorder assessed with the IPDE (Loranger et al., 1997) and BSL-23 (Wolf et al., 2009)
  time frame: Day 0, Month 6, Month 12, Month 24; IPDE only at Month 24
  measure: Change in psychiatric symptom severity assessed with the DASS- 21 (Lovibond & Lovibond, 1995)
  time frame: Day 0, Month 6, Month 12, Month 24
  measure: Change in health and disability assessed with WHODAS 2.0 Short Form (Üstün et al., 2010)
  time frame: Day 0, Month 6, Month 12, Month 24
  measure: Change in personality funcitioning assessed with LPFS-BF (Hutsebaut et al., 2016)
  time frame: Day 0, Month 6, Month 12, Month 24
  measure: Change in personality traits assessed with PID5BF+M (Bach et al., 2020)
  time frame: Day 0, Month 6, Month 12, Month 24
  measure: Change in threat hypersensitivity assessed with emotion classification task (Honecker et al., 2021)
  time frame: Day 0, Month 6, Month 12, Month 24
  description: Participants are presented with 160 faces, each unambiguously showing one of four emotional expressions (angry, fearful, happy, neutral). The goal of the task is to correctly classify these facial expressions. The task's collected behavioral data encompasses two key measurements: the ratio of accurate responses (specifically, correct emotion classification) and the time it takes to respond in trials where the emotion classification is correct.
  measure: Change in quality of life assessed with EQ-5D-5L (Herdman et al., 2011; EuroQol Research Foundation, 2019)
  time frame: Day 0, Month 6, Month 12, Month 24
  measure: Change in trait anger assessed with STAXI-2 (Spielberger, 1999)
  time frame: Day 0, Month 6, Month 12, Month 24
  measure: Change in social adjustment assessed with WSAS (Marks, 1986)
  time frame: Day 0, Month 6, Month 12, Month 24
  measure: Change in emotional reactions to social exclusion, rejection and relational devaluation with SPQ (Stangier et al., 2021)
  time frame: Day 0, Month 6, Month 12, Month 24
  measure: Change in Interoceptive Body Awareness with MAIA-2 (Mehling et al., 2018)
  time frame: Day 0, Month 6, Month 12, Month 24
  measure: Changes in medication with self-report of medication prescription via adapted version of AD-SUS (Kuyken et al., 2015)
  time frame: Day 0, Month 6, Month 12, Month 24
  measure: Heath Care utilization with an adapted version of the AD-SUS (Kuyken et al., 2015)
  time frame: Day 0, Month 6, Month 12, Month 24
  measure: Change in acute dissociative symptoms with Dissociation-Tension Scale-4 (DSS-4; Stiglmayr et al., 2003)
  time frame: Day 0, Month 6, Month 12, Month 24
  measure: Mentalizing as mediator of change assessed with the Certainty About Mental States Questionnaire (CAMSQ; Müller et al., 2021)
  time frame: Month 6, Month 12
  description: Mediator
  measure: Therapeutic Agency Inventory (TAI; Huber et al., 2019)
  time frame: once a week in the first year and at Month 6 and Month 12
  description: Mediator
  measure: Group Questionnaire - short (GQ; Jensen, 2016)
  time frame: once a week in the first year and at Month 6 and Month 12
  description: Mediator
  measure: Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ; Campbell et al., 2019)
  time frame: Month 6, Month 12
  description: Mediator
  measure: Experiences in Close Relationships-Revised Screening Version (ECR-RD8; Ehrenthal et al., 2021)
  time frame: Month 6, Month 12
  description: Mediator
  measure: Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
  time frame: Month 6, Month 12
  description: Mediator
  measure: Mentalizing as mediator of change assessed with Mentalizing Emotions Questionnaire (Kasper et al., submitted)
  time frame: Month 6, Month 12
  description: Mediator
  measure: Negative Effects Questionnaire (NEQ; Rozental et al., 2016)
  time frame: Month 12
  description: Serious adverse events of therapy
  measure: Therapeutic Alliance as mediator of change assessed with Working Alliance Inventory (WAI-SR, Hatcher & Gillaspy, 2006)
  time frame: once a week in the first year and at Month 6 and Month 12
  description: Mediator
  measure: Symptoms of PTSD and complex PTSD and complex PTSD Trauma experiences with Internation Trauma Interview (ITI; Roberts et al., 2019)
  time frame: Day 0
  description: Moderator
  measure: Symptoms of PTSD and complex PTSD with International Trauma Questionnaire (ITQ; Cloitre et al., 2018)
  time frame: Day 0
  description: Moderator
  measure: Level of personality functioning with Semi-Structured Interview for Personality Functioning DSM-5 (STiP; Hutsebaut et al., 2017)
  time frame: Day 0
  description: Moderator
  measure: Change of pleasure, arousal and dominance with Self-Assessment Manikin (Bradley, 1994)
  time frame: once a week in the first year and at Month 6 and Month 12
  description: Mediator
  measure: Change of frequency of occurence of positive and negative automatic thoughts with Automatic Thoughts Questionnaire - Revised (ATQ-R; Kendall, 1989)
  time frame: Month 6, Month 12
  description: Mediator
  measure: Assessment of the frequency of alliance ruptures and resolution processes in therapy sessions with Rupture Resolution Rating System (Eubanks et al., 2015)
  time frame: Month 6, Month 12
  description: Mediator
  measure: Assessment of the clients'attachment style with the Patient Attachment Coding System (Talia & Miller-Bottome, 2012)
  time frame: Month 6, Month 12
  description: Mediator
  measure: Assessment of the therapists' attunement and attachment status with the Therapist Attunement Scales (Talia & Muzi, 2017)
  time frame: Month 6, Month 12
  description: Mediator
  measure: Assessment of the therapists' activity and appropriateness in essential domains of MBT with the Mentalization-Based Treatment Adherence and Competence Scale (Bateman & Fonagy, 2016)
  time frame: Month 6, Month 12
  description: Mediator
  measure: Assessment of the therapists' adherence to psychodynamic-interpersonal and cognitive-behavioural treatments with the Comparative Psychotherapy Process Scale (Hilsenroth et al., 2005)
  time frame: Month 6, Month 12
  description: Mediator
  measure: Interview for treatment and study evaluation
  time frame: Month 24
  description: Semi-structured interview developed based on Krause et al. 2016 will be used to assess how patients experienced the therapy and the study, what aspects they perceived as positive or negative, and what impact the therapy had on their symptoms and their life
  arm group label: Mentalization-Based Treatment (MBT)
  arm group type: Experimental
  arm group label: Bona-Fide Treatment in Germany (BFT)
  arm group type: Active Comparator
  intervention type: Behavioral
  intervention name: Mentalization-Based Treatment (MBT)
  description: 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.
  arm group label: Mentalization-Based Treatment (MBT)
  intervention type: Behavioral
  intervention name: Bona-Fide Treatment in Germany (BFT)
  description: 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.
  arm group label: Bona-Fide Treatment in Germany (BFT)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Svenja Taubner
  role: Principal Investigator
  affiliation: University Heidelberg
  last name: Svenja Taubner, Prof.
  phone: +496221564701
  email: svenja.taubner@med.uni-heidelberg.de
  last name: Sophie Hauschild, Dr.
  email: sophie.hauschild@med.uni-heidelberg.de
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  responsible party type: Principal Investigator
  investigator affiliation: Heidelberg University
  investigator full name: Svenja Taubner
  investigator title: Prof. Dr. phil. Svenja Taubner
  mesh term: Personality Disorders
  mesh term: Borderline Personality Disorder
  sharing ipd: No