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/NCT05986552</url>
    </required_header>
    <id_info>
      <org_study_id>FMG-4449-2023</org_study_id>
      <nct_id>NCT05986552</nct_id>
    </id_info>
    <brief_title>The Influence of Treatment Format on Schema Therapy for Borderline Personality Disorder</brief_title>
    <acronym>IST-IGST</acronym>
    <official_title>The Influence of Treatment Format on Effectiveness of and Dropout From Schema Therapy for Borderline Personality Disorder: Individual vs. Combined Individual Group Schema Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Amsterdam</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Academic Center for Trauma and Personality</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ggz Oost Brabant</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>PsyQ Rotterdam</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Amsterdam</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this clinical trial is to compare etc. in patients with borderline personality&#xD;
        disorder pure individual schema therapy to combined individual-group schema therapy. The main&#xD;
        questions it aims to answer are:&#xD;
  &#xD;
          -  is there a difference in effectiveness?&#xD;
  &#xD;
          -  is there a difference in (early) treatment dropout?&#xD;
  &#xD;
        Participants will receive either&#xD;
  &#xD;
          -  individual schema therapy or&#xD;
  &#xD;
          -  combined individual-group schema therapy.&#xD;
  &#xD;
        Researchers will compare individual to combined individual-group schema therapy see if there&#xD;
        is a difference in effects and/or a difference in dropout from treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Schema Therapy (ST) for Borderline Personality Disorder (BPD) was originally developed and&#xD;
        tested as an individual treatment. Since 2009 group-ST became popular as an supposedly&#xD;
        efficient alternative. A RCT found combined individual-group ST to be superior to&#xD;
        predominantly group-ST. Thus, individual ST is important. The question arises how combined&#xD;
        individual-group ST compares to purely individual ST. This study compares the two formats of&#xD;
        ST in a multicenter randomized clinical trial (RCT). The primary outcomes are severity of BPD&#xD;
        and (early) treatment dropout. Secondary outcomes include: measures of specific BPD-symptoms;&#xD;
        schemas and schema-modes; general mental symptoms; general functioning; and happiness.&#xD;
        Moderators hypothesized to predict what patient characteristics are related to differences in&#xD;
        effectiveness between the 2 formats are also tested. At least 132 BPD patients from at least&#xD;
        5 sites will be randomized to combined individual-group ST or individual ST. Treatments will&#xD;
        take 2 years. Assessments take place every 6 months, and 1 year after end of treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 1, 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>
      <intervention_model_description>Multicenter Randomized Clinical Trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>Assessors and investigator are blind to treatment arm up to and including the last follow-up assessment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Borderline Personality Disorder Severity</measure>
      <time_frame>0, 6,12,18, 24 and 36 months</time_frame>
      <description>The severity of manifestations of Borderline Personality Disorder during the last 3 months, assessed with a semi-structured clinical interview, the Borderline Personality Disorder Severity Index 5 (BPDSI-5), by an independent trained rater, blind for treatment arm. Minimum score is 0; maximum is 90; higher scores mean worse outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Early treatment dropout rate</measure>
      <time_frame>6 months</time_frame>
      <description>Rate of dropout from treatment within the first 6 months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Severity of each of the 9 BPD criteria</measure>
      <time_frame>0, 6,12,18, 24 and 36 months</time_frame>
      <description>Severity of separate BPD criteria will be assessed with the subscales of the Borderline Personality Severity Index 5 (BPDSI-5). Each subscale has a range from 0 to 10, higher scores mean worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Suicidality</measure>
      <time_frame>0, 6,12,18, 24 and 36 months</time_frame>
      <description>Suicidality will be assessed by the pertinent criterion 5 items of the Borderline Personality Disorder Severity Index 5 (BPDSI-5). The range is 0-10, higher scores mean worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of suicide attempts</measure>
      <time_frame>0, 6,12,18, 24 and 36 months</time_frame>
      <description>Number of suicide attempts during the last 3 months will be assessed by item 5.13 of the Borderline Personality Disorder Severity Index 5 (BPDSI-5). The minimum is 0, the maximum is not defined. Higher scores mean worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective burden of Borderline Personality Disorder</measure>
      <time_frame>0, 6,12,18, 24 and 36 months</time_frame>
      <description>The subjective burden of Borderline Personality Disorder will be assessed with the Borderline Personality Disorder Checklist (BPDCL). The range is 47-235, higher scores mean worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General psychopathology symptoms</measure>
      <time_frame>0, 6,12,18, 24 and 36 months</time_frame>
      <description>General psychopathology symptoms will be assessed with the Brief Symptom Inventory (BSI). The range is 0-4, higher scores mean worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General, social, and societal functioning</measure>
      <time_frame>0, 6,12,18, 24 and 36 months</time_frame>
      <description>General, social, and societal functioning will be assessed with the World Health Organization Disability Assessment Schedule (WHODAS), taken by the research assistant who is blind for condition. The minimum score is 0, the maximum 100. Higher scores mean worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Happiness</measure>
      <time_frame>0, 6,12,18, 24 and 36 months</time_frame>
      <description>Happiness is assessed with the 1-item happiness question validated in more than 30 countries. Range is 1-7, higher scores mean better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Early Maladaptive Schemas</measure>
      <time_frame>0, 6,12,18, 24 and 36 months</time_frame>
      <description>Early Maladaptive Schemas will be assessed with the Young Schema Questionnaire short form (YSQ-SF). The range is 90-540; higher scores mean worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Schema Modes</measure>
      <time_frame>0, 6,12,18, 24 and 36 months</time_frame>
      <description>Schema Modes will be assessed with the Schema Mode Inventory (SMI). The minimum of the dysfunctional mode score is 123, the maximum 738, with higher scores meaning worse outcomes. The minimum of the functional modes score is 20, the maximum 120, with higher scores meaning better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of medications used</measure>
      <time_frame>0, 6,12,18, 24 and 36 months</time_frame>
      <description>Medication use will be monitored during treatment and at each assessment. The minimum number is zero; the maximum is not defined. Higher numbers mean worse outcomes.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">132</enrollment>
    <condition>Borderline Personality Disorder</condition>
    <arm_group>
      <arm_group_label>Individual Schema Therapy (IST)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>IST will follow the revised protocol described by Arntz &amp; van Genderen. In the first year, 2 sessions (of 50-60 minutes each) per week will be provided, with at least one day in between. In the second year, the frequency will be reduced to once a week for the first 6 months, for the next 3 months to once every two weeks, and for the last 3 months three (booster) sessions will be offered. Therapists need to be trained at least at the junior level of the Dutch ST Association, or of the International ST society (ISST), or having successfully completed the basic IST training and delivering the trial treatments under supervision of a recognized ST supervisor.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Combined Individual-Group Schema Therapy (IGST)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In IGST individual sessions (45-60 min) are provided weekly in the first year, and once every 2 weeks in the first three quarters of the second year, after which 3 monthly booster sessions are offered. Group sessions take place once per week for 1.5 years. After 1.5 years, patients leave the group but continue with IST during the last .5 year. If slots are available, new patients can enter the ST group every 10 weeks.&#xD;
  GST is provided as semi-closed group format developed from the closed format as developed by Farrell &amp; Shaw. IST is based on Arntz &amp; van Genderen, with the addition that IST and GST are coordinated at weekly peer supervision meetings, and that problems related to the patient's participation in the group are put on the IST agenda.&#xD;
  GST therapists don't need to be IST therapist of their patients. The same training requirements hold as in the IST arm. Additionally, GST-therapists completed GST training and receive(d) at least 10 GST supervisions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Individual Schema Therapy (IST)</intervention_name>
      <description>IST is a form of empirically supported specialized psychotherapy for personality disorders. It is delivered in individual sessions by trained therapists.</description>
      <arm_group_label>Individual Schema Therapy (IST)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Individual-Group Schema Therapy (IGST)</intervention_name>
      <description>IGST is a form of empirically supported specialized psychotherapy for personality disorders. It is delivered in the combination of individual sessions and group therapy sessions by trained therapists.</description>
      <arm_group_label>Combined Individual-Group Schema Therapy (IGST)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  BPD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th&#xD;
               edition (DSM-5), assessed with the Structured Clinical Interview for the DSM-5&#xD;
               Personality Disorders (SCID-5-PD), as primary diagnosis&#xD;
  &#xD;
            -  BPDSI total score ≥ 20 (i.e, severity in the BPD range, Giesen-Bloo et al., 2010)&#xD;
  &#xD;
            -  Ability to understand, read, write and speak Dutch, or English if the site has&#xD;
               research assistants and therapists of both conditions that are sufficiently fluent in&#xD;
               English, as well as an English ST group (as at ACTP).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  DSM-5 substance use disorder that needs clinical detox according to the clinical staff&#xD;
               (after 6 weeks of abstinence participation is possible).&#xD;
  &#xD;
            -  Comorbid psychotic disorder (patients with temporary psychotic problems falling under&#xD;
               BPD criterion 9 are not excluded)&#xD;
  &#xD;
            -  DSM-5 Bipolar disorder, type 1 (current or past)&#xD;
  &#xD;
            -  Acute suicide risk&#xD;
  &#xD;
            -  Intelligence Quotient (IQ) &lt; 80&#xD;
  &#xD;
            -  Serious neurological problems such as dementia&#xD;
  &#xD;
            -  Patients should not start with any form of psychological treatment during screening or&#xD;
               during the study's waitlist or treatment. (Low frequency supportive treatment may be&#xD;
               continued during wait and screening, but not during the study treatment.)&#xD;
  &#xD;
            -  Not able or willing to plan participation in the treatment sessions. Note 1. In case&#xD;
               of suspicion of exclusion criteria that need specific assessment, like IQ and&#xD;
               dementia, a formal diagnostic assessment needs to be done before in/exclusion can be&#xD;
               decided.&#xD;
  &#xD;
          Note 2. No other psychological treatment during the study follow-up period is provided,&#xD;
          unless this is necessary (clinical judgment). The 1 year treatment-free follow-up period is&#xD;
          part of the treatment protocol, to help patients gain experience with life without mental&#xD;
          health care. After 1 year further treatment can be offered, if indicated.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Arnoud Arntz, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Amsterdam</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Arnoud Arntz, PhD</last_name>
      <phone>+31 20 525 6810</phone>
      <email>a.r.arntz@uva.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anika Vermeulen, MSc</last_name>
      <email>anika.vermeulen@actp.nl</email>
    </overall_contact_backup>
    <reference>
      <citation>Arntz, A. &amp; van Genderen, H. (2020). Schema Therapy for Borderline Personality Disorder, 2nd Edition. Chichester, UK: John Wiley &amp; Sons.</citation>
    </reference>
    <reference>
      <citation>Arntz A, Mensink K, Cox WR, Verhoef REJ, van Emmerik AAP, Rameckers SA, Badenbach T, Grasman RPPP. Dropout from psychological treatment for borderline personality disorder: a multilevel survival meta-analysis. Psychol Med. 2023 Feb;53(3):668-686. doi: 10.1017/S0033291722003634. Epub 2022 Dec 1.</citation>
      <PMID>36453183</PMID>
    </reference>
    <reference>
      <citation>Arntz A, Jacob GA, Lee CW, Brand-de Wilde OM, Fassbinder E, Harper RP, Lavender A, Lockwood G, Malogiannis IA, Ruths FA, Schweiger U, Shaw IA, Zarbock G, Farrell JM. Effectiveness of Predominantly Group Schema Therapy and Combined Individual and Group Schema Therapy for Borderline Personality Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Apr 1;79(4):287-299. doi: 10.1001/jamapsychiatry.2022.0010.</citation>
      <PMID>35234828</PMID>
    </reference>
    <reference>
      <citation>Bloo J, Arntz A, Schouten E. The Borderline Personality Disorder Checklist: Psychometric evaluation and factorial structure in clinical and nonclinical samples. Roczniki Psychologiczne // Annals of Psychology. 2017; 20(2): 281-336. http://dx.doi.org/10.18290/rpsych.2017.20.2-3en</citation>
    </reference>
    <reference>
      <citation>Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.</citation>
      <PMID>6622612</PMID>
    </reference>
    <reference>
      <citation>Farrell, J.M. &amp; Shaw, I.A. (2012). Group schema therapy for borderline personality disorder: A step-by-step treatment manual with patient workbook. Hoboken: Wiley.</citation>
    </reference>
    <reference>
      <citation>Giesen-Bloo JH, Wachters, LM, Schouten E, Arntz A. The Borderline Personality Disorder Severity Index-IV: Psychometric evaluation and dimensional structure. Personality and Individual Differences. 2010; 49: 136-141.</citation>
    </reference>
    <reference>
      <citation>Lobbestael J, van Vreeswijk M, Spinhoven P, Schouten E, Arntz A. Reliability and validity of the short Schema Mode Inventory (SMI). Behav Cogn Psychother. 2010 Jul;38(4):437-58. doi: 10.1017/S1352465810000226. Epub 2010 May 21.</citation>
      <PMID>20487590</PMID>
    </reference>
    <reference>
      <citation>Üstün TB, Kostanjsek, N, Chatterji, S, Rehm, J. Measuring health and disability: manual for WHO disability assessment schedule WHODAS 2.0. Geneva: World Health Organization, 2010.</citation>
    </reference>
    <reference>
      <citation>Veenhoven R. World Database of Happiness. 2023. https://worlddatabaseofhappiness.eur.nl/.</citation>
    </reference>
    <reference>
      <citation>Young JE, Brown, G. Young Schema Questionnaire-Short Form; Version 3 (YSQ-S3, YSQ) [Database record]. APA PsycTests, 2005. https://doi.org/10.1037/t67023-000</citation>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Amsterdam</investigator_affiliation>
      <investigator_full_name>Arnoud Arntz</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Borderline Personality Disorder</keyword>
    <keyword>Schema Therapy</keyword>
    <keyword>Psychotherapy</keyword>
    <keyword>Therapy format</keyword>
    <keyword>Randomized Clinical Trial</keyword>
    <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>
      <ipd_description>Given Dutch and European Union legal data protection regulations sharing individual data with other researchers can only be considered if other researchers can guarantee meeting strict conditions.</ipd_description>
    </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/NCT05986552
  org study id: FMG-4449-2023
  nct id: NCT05986552
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare etc. in patients with borderline personality
        disorder pure individual schema therapy to combined individual-group schema therapy. The main
        questions it aims to answer are:
  
          -  is there a difference in effectiveness?
  
          -  is there a difference in (early) treatment dropout?
  
        Participants will receive either
  
          -  individual schema therapy or
  
          -  combined individual-group schema therapy.
  
        Researchers will compare individual to combined individual-group schema therapy see if there
        is a difference in effects and/or a difference in dropout from treatment.
  Schema Therapy (ST) for Borderline Personality Disorder (BPD) was originally developed and
        tested as an individual treatment. Since 2009 group-ST became popular as an supposedly
        efficient alternative. A RCT found combined individual-group ST to be superior to
        predominantly group-ST. Thus, individual ST is important. The question arises how combined
        individual-group ST compares to purely individual ST. This study compares the two formats of
        ST in a multicenter randomized clinical trial (RCT). The primary outcomes are severity of BPD
        and (early) treatment dropout. Secondary outcomes include: measures of specific BPD-symptoms;
        schemas and schema-modes; general mental symptoms; general functioning; and happiness.
        Moderators hypothesized to predict what patient characteristics are related to differences in
        effectiveness between the 2 formats are also tested. At least 132 BPD patients from at least
        5 sites will be randomized to combined individual-group ST or individual ST. Treatments will
        take 2 years. Assessments take place every 6 months, and 1 year after end of treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Multicenter Randomized Clinical Trial
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: Assessors and investigator are blind to treatment arm up to and including the last follow-up assessment.
  measure: Borderline Personality Disorder Severity
  time frame: 0, 6,12,18, 24 and 36 months
  description: The severity of manifestations of Borderline Personality Disorder during the last 3 months, assessed with a semi-structured clinical interview, the Borderline Personality Disorder Severity Index 5 (BPDSI-5), by an independent trained rater, blind for treatment arm. Minimum score is 0; maximum is 90; higher scores mean worse outcome.
  measure: Early treatment dropout rate
  time frame: 6 months
  description: Rate of dropout from treatment within the first 6 months
  measure: Severity of each of the 9 BPD criteria
  time frame: 0, 6,12,18, 24 and 36 months
  description: Severity of separate BPD criteria will be assessed with the subscales of the Borderline Personality Severity Index 5 (BPDSI-5). Each subscale has a range from 0 to 10, higher scores mean worse outcomes.
  measure: Suicidality
  time frame: 0, 6,12,18, 24 and 36 months
  description: Suicidality will be assessed by the pertinent criterion 5 items of the Borderline Personality Disorder Severity Index 5 (BPDSI-5). The range is 0-10, higher scores mean worse outcomes.
  measure: Number of suicide attempts
  time frame: 0, 6,12,18, 24 and 36 months
  description: Number of suicide attempts during the last 3 months will be assessed by item 5.13 of the Borderline Personality Disorder Severity Index 5 (BPDSI-5). The minimum is 0, the maximum is not defined. Higher scores mean worse outcomes.
  measure: Subjective burden of Borderline Personality Disorder
  time frame: 0, 6,12,18, 24 and 36 months
  description: The subjective burden of Borderline Personality Disorder will be assessed with the Borderline Personality Disorder Checklist (BPDCL). The range is 47-235, higher scores mean worse outcome.
  measure: General psychopathology symptoms
  time frame: 0, 6,12,18, 24 and 36 months
  description: General psychopathology symptoms will be assessed with the Brief Symptom Inventory (BSI). The range is 0-4, higher scores mean worse outcome.
  measure: General, social, and societal functioning
  time frame: 0, 6,12,18, 24 and 36 months
  description: General, social, and societal functioning will be assessed with the World Health Organization Disability Assessment Schedule (WHODAS), taken by the research assistant who is blind for condition. The minimum score is 0, the maximum 100. Higher scores mean worse outcome.
  measure: Happiness
  time frame: 0, 6,12,18, 24 and 36 months
  description: Happiness is assessed with the 1-item happiness question validated in more than 30 countries. Range is 1-7, higher scores mean better outcomes.
  measure: Early Maladaptive Schemas
  time frame: 0, 6,12,18, 24 and 36 months
  description: Early Maladaptive Schemas will be assessed with the Young Schema Questionnaire short form (YSQ-SF). The range is 90-540; higher scores mean worse outcomes.
  measure: Schema Modes
  time frame: 0, 6,12,18, 24 and 36 months
  description: Schema Modes will be assessed with the Schema Mode Inventory (SMI). The minimum of the dysfunctional mode score is 123, the maximum 738, with higher scores meaning worse outcomes. The minimum of the functional modes score is 20, the maximum 120, with higher scores meaning better outcomes.
  measure: Number of medications used
  time frame: 0, 6,12,18, 24 and 36 months
  description: Medication use will be monitored during treatment and at each assessment. The minimum number is zero; the maximum is not defined. Higher numbers mean worse outcomes.
  arm group label: Individual Schema Therapy (IST)
  arm group type: Active Comparator
  description: IST will follow the revised protocol described by Arntz & van Genderen. In the first year, 2 sessions (of 50-60 minutes each) per week will be provided, with at least one day in between. In the second year, the frequency will be reduced to once a week for the first 6 months, for the next 3 months to once every two weeks, and for the last 3 months three (booster) sessions will be offered. Therapists need to be trained at least at the junior level of the Dutch ST Association, or of the International ST society (ISST), or having successfully completed the basic IST training and delivering the trial treatments under supervision of a recognized ST supervisor.
  arm group label: Combined Individual-Group Schema Therapy (IGST)
  arm group type: Active Comparator
  description: In IGST individual sessions (45-60 min) are provided weekly in the first year, and once every 2 weeks in the first three quarters of the second year, after which 3 monthly booster sessions are offered. Group sessions take place once per week for 1.5 years. After 1.5 years, patients leave the group but continue with IST during the last .5 year. If slots are available, new patients can enter the ST group every 10 weeks.
  GST is provided as semi-closed group format developed from the closed format as developed by Farrell & Shaw. IST is based on Arntz & van Genderen, with the addition that IST and GST are coordinated at weekly peer supervision meetings, and that problems related to the patient's participation in the group are put on the IST agenda.
  GST therapists don't need to be IST therapist of their patients. The same training requirements hold as in the IST arm. Additionally, GST-therapists completed GST training and receive(d) at least 10 GST supervisions.
  intervention type: Behavioral
  intervention name: Individual Schema Therapy (IST)
  description: IST is a form of empirically supported specialized psychotherapy for personality disorders. It is delivered in individual sessions by trained therapists.
  arm group label: Individual Schema Therapy (IST)
  intervention type: Behavioral
  intervention name: Individual-Group Schema Therapy (IGST)
  description: IGST is a form of empirically supported specialized psychotherapy for personality disorders. It is delivered in the combination of individual sessions and group therapy sessions by trained therapists.
  arm group label: Combined Individual-Group Schema Therapy (IGST)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Arnoud Arntz, PhD
  role: Principal Investigator
  affiliation: University of Amsterdam
  last name: Arnoud Arntz, PhD
  phone: +31 20 525 6810
  email: a.r.arntz@uva.nl
  last name: Anika Vermeulen, MSc
  email: anika.vermeulen@actp.nl
  citation: Arntz, A. & van Genderen, H. (2020). Schema Therapy for Borderline Personality Disorder, 2nd Edition. Chichester, UK: John Wiley & Sons.
  citation: Arntz A, Mensink K, Cox WR, Verhoef REJ, van Emmerik AAP, Rameckers SA, Badenbach T, Grasman RPPP. Dropout from psychological treatment for borderline personality disorder: a multilevel survival meta-analysis. Psychol Med. 2023 Feb;53(3):668-686. doi: 10.1017/S0033291722003634. Epub 2022 Dec 1.
  PMID: 36453183
  citation: Arntz A, Jacob GA, Lee CW, Brand-de Wilde OM, Fassbinder E, Harper RP, Lavender A, Lockwood G, Malogiannis IA, Ruths FA, Schweiger U, Shaw IA, Zarbock G, Farrell JM. Effectiveness of Predominantly Group Schema Therapy and Combined Individual and Group Schema Therapy for Borderline Personality Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Apr 1;79(4):287-299. doi: 10.1001/jamapsychiatry.2022.0010.
  PMID: 35234828
  citation: Bloo J, Arntz A, Schouten E. The Borderline Personality Disorder Checklist: Psychometric evaluation and factorial structure in clinical and nonclinical samples. Roczniki Psychologiczne // Annals of Psychology. 2017; 20(2): 281-336. http://dx.doi.org/10.18290/rpsych.2017.20.2-3en
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  PMID: 6622612
  citation: Farrell, J.M. & Shaw, I.A. (2012). Group schema therapy for borderline personality disorder: A step-by-step treatment manual with patient workbook. Hoboken: Wiley.
  citation: Giesen-Bloo JH, Wachters, LM, Schouten E, Arntz A. The Borderline Personality Disorder Severity Index-IV: Psychometric evaluation and dimensional structure. Personality and Individual Differences. 2010; 49: 136-141.
  citation: Lobbestael J, van Vreeswijk M, Spinhoven P, Schouten E, Arntz A. Reliability and validity of the short Schema Mode Inventory (SMI). Behav Cogn Psychother. 2010 Jul;38(4):437-58. doi: 10.1017/S1352465810000226. Epub 2010 May 21.
  PMID: 20487590
  citation: Üstün TB, Kostanjsek, N, Chatterji, S, Rehm, J. Measuring health and disability: manual for WHO disability assessment schedule WHODAS 2.0. Geneva: World Health Organization, 2010.
  citation: Veenhoven R. World Database of Happiness. 2023. https://worlddatabaseofhappiness.eur.nl/.
  citation: Young JE, Brown, G. Young Schema Questionnaire-Short Form; Version 3 (YSQ-S3, YSQ) [Database record]. APA PsycTests, 2005. https://doi.org/10.1037/t67023-000
  responsible party type: Principal Investigator
  investigator affiliation: University of Amsterdam
  investigator full name: Arnoud Arntz
  investigator title: Professor
  mesh term: Personality Disorders
  mesh term: Borderline Personality Disorder
  sharing ipd: No
  ipd description: Given Dutch and European Union legal data protection regulations sharing individual data with other researchers can only be considered if other researchers can guarantee meeting strict conditions.