<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/NCT03295838</url>
  </required_header>
  <id_info>
    <org_study_id>DNR 2011/1909-31/3</org_study_id>
    <nct_id>NCT03295838</nct_id>
  </id_info>
  <brief_title>Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder</brief_title>
  <official_title>Symptom, Alexithymia and Self-image Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder: a Naturalistic Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</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 effects of a psychological treatment, Mentalization-Based Treatment, was studied using a&#xD;
      research protocol with patients with mood swings and impulsive behavior (borderline&#xD;
      personality disorder).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Mentalization-based treatment (MBT) in borderline personality disorder (BPD) has&#xD;
      a growing evidence base, but there is a lack of effectiveness and moderator studies. The&#xD;
      present study examined the effectiveness of MBT in a naturalistic setting and explored&#xD;
      psychiatric and psychological moderators of outcome. Method: Borderline and general&#xD;
      psychiatric symptoms, suicidality, self-harm, alexithymia and self-image were measured in a&#xD;
      group of BPD patients (n=75) receiving MBT; assessments were made at baseline, and&#xD;
      subsequently after 6, 12 and 18 months (when treatment ended). Borderline symptoms were the&#xD;
      primary outcome variable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2007</start_date>
  <completion_date type="Actual">May 3, 2014</completion_date>
  <primary_completion_date type="Actual">May 3, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients were selected using a research protocol with defined criteria, all patients that were intended to treat in the Mentalization-based Treatment program were followed over 18 months and assessed for primary and secondary outcomes.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Borderline Symptoms</measure>
    <time_frame>0-18 months</time_frame>
    <description>Key psychiatric and borderline symptomatology as measured by the Karolinska Borderline And Symptoms Scales (KABOSS-S) was the primary outcome measure. The KABOSS-S consists of three general symptom scales (depression, anxiety, obsessive-compulsive symptoms) derived from the Comprehensive Psychopathological Self-rating Scale for Affective Syndromes and one specific borderline scale compromising the items &quot;Mood swings&quot;, &quot;Ability to understand own emotions&quot;, &quot;Self-control&quot;, &quot;Self-soothing&quot;, &quot;Feelings of abandonment&quot;, &quot;Feelings of emptiness&quot;, &quot;Self-image&quot; and &quot;Reality Presence&quot;. Each item is scored on a Likert scale from 0 (&quot;no presence&quot;) to 6 (&quot;severe&quot;).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Suicidality</measure>
    <time_frame>0-18 months</time_frame>
    <description>Suicidality was measured by the Suicide Assessment Scale, Self-Report (SUAS-S), which covers factors known to influence suicide risk, such as affect, bodily states, control and coping, emotional reactivity, as well as suicidal thoughts and behaviour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Psychiatric Symptoms</measure>
    <time_frame>0-18 months</time_frame>
    <description>General psychiatric symptoms were measured using the Symptom Checklist-90 Revised (SCL-90-R), an established instrument with well-known reliability and validity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-harm</measure>
    <time_frame>0-18 months</time_frame>
    <description>Self-harm was measured by the Deliberate Self-Harm Inventory-9 (DSHI-9), which has well-known reliability and validity. This measure was introduced halfway through the study period (N=42).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alexithymia</measure>
    <time_frame>0-18 months</time_frame>
    <description>The Toronto Alexithymia Scale-20 (TAS-20) was used to measure alexithymia. It comprises 20 items divided into three subscales: Difficulty Identifying Feelings, Difficulty Expressing Feelings and Externally Oriented Thinking. TAS-20 was used to measure affective mentalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-image</measure>
    <time_frame>0-18 months</time_frame>
    <description>Self-image was assessed using Structural Analysis of Social Behavior (SASB). SASB is based on a circumplex model, measuring self-image and interpersonal interactions in relation to three interpersonal &quot;surfaces&quot; (i.e. actions of others, reactions to others and the introject, or what can be called the self-image. The third surface (self-image) was used, which comprises eight clusters of self-image: 1) Autonomy; 2) Self-affirmation; 3) Active self-love; 4) Self-protection; 5) Self-control; 6) Self-blame; 7) Self-attack; and 8) Self-neglect.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Borderline Personality Disorder</condition>
  <arm_group>
    <arm_group_label>Mentalization-based Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MBT was conducted according to the treatment manual developed by Bateman &amp; Fonagy. Patients were offered individual sessions with a psychotherapist and group sessions with 6-8 participants and 1-2 group therapists for 18 months. An introductory psycho-educational component (9-12 sessions) was also offered focusing on explicit mentalising skills (i.e. understanding one's own or others' intentions). Group and individual MBT focused on implicit mentalising towards self and others.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mentalization-based treatment</intervention_name>
    <description>See Arm description</description>
    <arm_group_label>Mentalization-based Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be included, BPD diagnosis was confirmed by SCID-II interview and the Zanarini&#xD;
             Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview, together with a&#xD;
             consensus discussion between MBT therapists using DSM-IV and ICD-10 criteria. All&#xD;
             patients referred between 2007-02-01 and 2012-05-30 were eligible for inclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria were: IQ&lt;85, psychotic disorder other than schizotypal personality&#xD;
             disorder, acute/temporary psychosis, previously diagnosed autism-spectrum disorder,&#xD;
             bipolar disorder type I and severe eating or substance use disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-identification.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Viktor Kaldo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Viktor Kaldo</investigator_full_name>
    <investigator_title>Med PhD, clinical psychologist, associate professor, research team leader</investigator_title>
  </responsible_party>
  <keyword>Borderline personality disorder</keyword>
  <keyword>Psychotherapy</keyword>
  <keyword>Treatment outcome</keyword>
  <keyword>Pragmatic clinical trials as topic</keyword>
  <keyword>Mentalization-based treatment</keyword>
  <keyword>Alexithymia</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>Yes</sharing_ipd>
    <ipd_description>The dataset used and/or analysed during the current study are available from the corresponding author on reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>1st feb 2007 - 3rd may 2014.</ipd_time_frame>
    <ipd_access_criteria>Upon reasonable request.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03295838
org study id: DNR 2011/1909-31/3
nct id: NCT03295838
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The effects of a psychological treatment, Mentalization-Based Treatment, was studied using a
      research protocol with patients with mood swings and impulsive behavior (borderline
      personality disorder).
Background: Mentalization-based treatment (MBT) in borderline personality disorder (BPD) has
      a growing evidence base, but there is a lack of effectiveness and moderator studies. The
      present study examined the effectiveness of MBT in a naturalistic setting and explored
      psychiatric and psychological moderators of outcome. Method: Borderline and general
      psychiatric symptoms, suicidality, self-harm, alexithymia and self-image were measured in a
      group of BPD patients (n=75) receiving MBT; assessments were made at baseline, and
      subsequently after 6, 12 and 18 months (when treatment ended). Borderline symptoms were the
      primary outcome variable.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients were selected using a research protocol with defined criteria, all patients that were intended to treat in the Mentalization-based Treatment program were followed over 18 months and assessed for primary and secondary outcomes.
primary purpose: Treatment
masking: None (Open Label)
measure: Borderline Symptoms
time frame: 0-18 months
description: Key psychiatric and borderline symptomatology as measured by the Karolinska Borderline And Symptoms Scales (KABOSS-S) was the primary outcome measure. The KABOSS-S consists of three general symptom scales (depression, anxiety, obsessive-compulsive symptoms) derived from the Comprehensive Psychopathological Self-rating Scale for Affective Syndromes and one specific borderline scale compromising the items "Mood swings", "Ability to understand own emotions", "Self-control", "Self-soothing", "Feelings of abandonment", "Feelings of emptiness", "Self-image" and "Reality Presence". Each item is scored on a Likert scale from 0 ("no presence") to 6 ("severe").
measure: Suicidality
time frame: 0-18 months
description: Suicidality was measured by the Suicide Assessment Scale, Self-Report (SUAS-S), which covers factors known to influence suicide risk, such as affect, bodily states, control and coping, emotional reactivity, as well as suicidal thoughts and behaviour.
measure: General Psychiatric Symptoms
time frame: 0-18 months
description: General psychiatric symptoms were measured using the Symptom Checklist-90 Revised (SCL-90-R), an established instrument with well-known reliability and validity.
measure: Self-harm
time frame: 0-18 months
description: Self-harm was measured by the Deliberate Self-Harm Inventory-9 (DSHI-9), which has well-known reliability and validity. This measure was introduced halfway through the study period (N=42).
measure: Alexithymia
time frame: 0-18 months
description: The Toronto Alexithymia Scale-20 (TAS-20) was used to measure alexithymia. It comprises 20 items divided into three subscales: Difficulty Identifying Feelings, Difficulty Expressing Feelings and Externally Oriented Thinking. TAS-20 was used to measure affective mentalization.
measure: Self-image
time frame: 0-18 months
description: Self-image was assessed using Structural Analysis of Social Behavior (SASB). SASB is based on a circumplex model, measuring self-image and interpersonal interactions in relation to three interpersonal "surfaces" (i.e. actions of others, reactions to others and the introject, or what can be called the self-image. The third surface (self-image) was used, which comprises eight clusters of self-image: 1) Autonomy; 2) Self-affirmation; 3) Active self-love; 4) Self-protection; 5) Self-control; 6) Self-blame; 7) Self-attack; and 8) Self-neglect.
arm group label: Mentalization-based Treatment
arm group type: Experimental
description: MBT was conducted according to the treatment manual developed by Bateman & Fonagy. Patients were offered individual sessions with a psychotherapist and group sessions with 6-8 participants and 1-2 group therapists for 18 months. An introductory psycho-educational component (9-12 sessions) was also offered focusing on explicit mentalising skills (i.e. understanding one's own or others' intentions). Group and individual MBT focused on implicit mentalising towards self and others.
intervention type: Behavioral
intervention name: Mentalization-based treatment
description: See Arm description
arm group label: Mentalization-based Treatment
criteria: 
gender: All
gender based: Yes
gender description: Self-identification.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Viktor Kaldo, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Viktor Kaldo
investigator title: Med PhD, clinical psychologist, associate professor, research team leader
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder
sharing ipd: Yes
ipd description: The dataset used and/or analysed during the current study are available from the corresponding author on reasonable request.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: 1st feb 2007 - 3rd may 2014.
ipd access criteria: Upon reasonable request.