<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/NCT01719731</url>
  </required_header>
  <id_info>
    <org_study_id>1R34MH095818</org_study_id>
    <nct_id>NCT01719731</nct_id>
  </id_info>
  <brief_title>Psychoeducation of Borderline Patients</brief_title>
  <official_title>Psychoeducation of Borderline Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mclean Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mclean Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent research suggests that BPD is a common, serious but treatable disorder with a better&#xD;
      than previously recognized prognosis. Despite these findings, many patients with BPD are not&#xD;
      given the borderline diagnosis by the mental health professionals treating them. It is also&#xD;
      true that many newly diagnosed borderline patients are not provided with up-to-date&#xD;
      information on the disorder even though psychoeducation has been found to be a useful form of&#xD;
      treatment for other serious psychiatric illnesses.&#xD;
&#xD;
      The investigators have conducted a preliminary randomized trial of psychoeducation for BPD&#xD;
      that found that those provided with immediate psychoeducation had a significantly greater&#xD;
      reduction in two core symptoms of BPD--general impulsivity and stormy relationships--than&#xD;
      those with delayed psychoeducation.&#xD;
&#xD;
      However, both instruction and assessment of change over time were conducted in person by&#xD;
      paraprofessionals. The importance of the current study is that it will allow the&#xD;
      investigators to develop and test the efficacy of an internet-based program of&#xD;
      psychoeducation for BPD that will be both cost efficient and easy to disseminate widely,&#xD;
      particularly to underserved populations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical experience suggests that many people with borderline personality disorder (BPD) are&#xD;
      not told of their borderline diagnosis by those treating them. Clinical experience also&#xD;
      suggests that many people with newly diagnosed BPD are not provided with up-to-date&#xD;
      information on the disorder. These practices are unfortunate as the results of a preliminary,&#xD;
      randomized, controlled trial of psychoeducation for BPD conducted by the investigators&#xD;
      suggest that informing patients about BPD soon after diagnostic disclosure may be an&#xD;
      effective form of early treatment for BPD as it significantly reduced the severity of two of&#xD;
      the core symptoms of borderline psychopathology-general impulsivity and unstable&#xD;
      relationships.&#xD;
&#xD;
      This application proposes building on the PI's prior work in this area by developing a&#xD;
      web-based program for the education of those with BPD and the assessment of three key&#xD;
      outcomes; psychoeducation and assessment of outcome that had previously been provided by a&#xD;
      team of clinically experienced research assistants. Both of these initiatives would allow for&#xD;
      the widespread, cost-efficient dissemination of this early form of treatment for BPD-a form&#xD;
      of treatment that has proven effective for other serious psychiatric illnesses.&#xD;
&#xD;
      The investigators first aim is to update our curriculum for teaching individuals with BPD the&#xD;
      latest information concerning the disorder. This information will be organized into seven&#xD;
      modules: introductory information (history of diagnosis, stigma associated with disorder, and&#xD;
      demographic characteristics associated with BPD), symptoms of BPD, co-occurring disorders,&#xD;
      etiology, longitudinal course, psychosocial treatments, and psychotropic medications. Some&#xD;
      modules will be divided into sub-modules. For example, etiology will encompass childhood&#xD;
      adversity, family history of psychiatric disorder, temperament, genetics, and other&#xD;
      biological findings.&#xD;
&#xD;
      The investigators second aim is to develop a website for teaching the most up-to-date&#xD;
      information about BPD and assessing three key outcomes: the severity of borderline&#xD;
      psychopathology, psychosocial impairment, and treatment utilization over time. These outcomes&#xD;
      will be assessed using self-report measures with proven psychometric properties. Symptom&#xD;
      severity will be accomplished through the internet-based administration of the self-report&#xD;
      version of the already widely used Zanarini Rating Scale for Borderline Personality Disorder&#xD;
      (ZAN-BPD)-a dimensional measure of the nine Diagnostic and Statistical Manual of Mental&#xD;
      Disorders, fourth edition(DSM-IV) symptoms of BPD. The investigators will also use the&#xD;
      Borderline Evaluation of Severity over Time (BEST) developed by Pfohl and Blum as a secondary&#xD;
      measure of change in severity of borderline psychopathology. Two other self-report measures&#xD;
      will be used to assess psychosocial impairment (Sheehan Disability Scale and Weissman's&#xD;
      Social Adjustment Scale). The use of nine forms of psychiatric treatment will be assessed&#xD;
      using a self-report version of the treatment section of the Background Information Schedule&#xD;
      and its follow-up analog.&#xD;
&#xD;
      The investigators third aim is to conduct a small-scale randomized controlled trial of&#xD;
      psychoeducation for BPD using this set of web-based instructional and assessment tools. Half&#xD;
      of the 80 subjects will be randomized to the investigators web-based intervention, which will&#xD;
      occur a week after diagnostic disclosure, and half will not. The investigators plan to assess&#xD;
      symptom severity, psychosocial impairment, and treatment utilization each week for 12 weeks&#xD;
      (as the investigators did in our prior study) using the web-based self-report measures&#xD;
      described above to determine its immediate effects. The investigators also plan to assess&#xD;
      these outcomes using these measures at six months, nine months, and 12 months after&#xD;
      randomization to determine if these effects are long lasting. The investigators hypothesize&#xD;
      that two of the nine symptoms of DSM-IV BPD will decline significantly more in the subjects&#xD;
      who receive psychoeducation than those who do not-general impulsivity and unstable&#xD;
      relationships. The investigators further hypothesize that those in the treatment group will&#xD;
      have more improved functioning in the social and vocational (but not family realm) than those&#xD;
      in the non-treatment group. Finally, the investigators hypothesize that those receiving&#xD;
      psychoeducation will be more likely to seek out ongoing psychiatric treatment and less likely&#xD;
      to use emergency psychiatric services, such as hospitalizations, than those who do not&#xD;
      receive psychoeducation concerning BPD.&#xD;
&#xD;
      If successful, the results of this trial would provide further evidence that psychoeducation&#xD;
      is a useful form of early treatment for BPD. These results would also suggest that our&#xD;
      web-based platform is an effective and cost efficient method for delivering such a program.&#xD;
      Finally, these results would pave the way for a large-scale, multi-site randomized controlled&#xD;
      trial of this web-based program in community settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Zanarini Rating Scale for Borderline Personality Disorder</measure>
    <time_frame>Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up</time_frame>
    <description>A dimensional self-report measure of the nine DSM-IV symptoms of BPD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Borderline Evaluation of Severity over Time</measure>
    <time_frame>Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up</time_frame>
    <description>A self-report that measures change in severity of borderline psychopathology</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sheehan Disability Scale</measure>
    <time_frame>Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up</time_frame>
    <description>A self-report measure used to assess psychosocial impairment</description>
  </other_outcome>
  <other_outcome>
    <measure>Weissman's Social Adjustment Scale</measure>
    <time_frame>Change from baseline through weeks 4,8,12, 6 month follow-up, 9 month follow-up, 12 month follow-up</time_frame>
    <description>A self-report measure used to assess psychosocial impairment</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinically Useful Depression Outcome Scale</measure>
    <time_frame>Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up</time_frame>
    <description>A self-report designed to assess sensitivity to change in depression symptoms</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinically Useful Anxiety Outcome Scale</measure>
    <time_frame>Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up</time_frame>
    <description>A self-report designed to assess sensitivity to change in anxiety symptoms</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Borderline Personality Disorder</condition>
  <arm_group>
    <arm_group_label>Non-Education</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will not receive the psychosocial education.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive the psychosocial education</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>This group will receive the psychoeducation</description>
    <arm_group_label>Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Non-Education</intervention_name>
    <description>This group will not receive the psychoeducation</description>
    <arm_group_label>Non-Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Ages 18 to 30&#xD;
&#xD;
          -  Meets criteria for Borderline Personality Disorder&#xD;
&#xD;
          -  Intelligence Quotient must be 71 or higher&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Schizophrenia&#xD;
&#xD;
          -  Schizoaffective Disorder&#xD;
&#xD;
          -  Bipolar I&#xD;
&#xD;
          -  Serious Substance Use Disorder&#xD;
&#xD;
          -  Subjects cannot be in treatment at baseline&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary C Zanarini, Ed.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mclean Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McLean Hospital</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>September 23, 2015</last_update_submitted>
  <last_update_submitted_qc>September 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mclean Hospital</investigator_affiliation>
    <investigator_full_name>Mary Zanarini</investigator_full_name>
    <investigator_title>Professor of Psychology</investigator_title>
  </responsible_party>
  <keyword>BPD</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>
  <!-- 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/NCT01719731
org study id: 1R34MH095818
nct id: NCT01719731
lead sponsor: 
has dmc: Yes
Recent research suggests that BPD is a common, serious but treatable disorder with a better
      than previously recognized prognosis. Despite these findings, many patients with BPD are not
      given the borderline diagnosis by the mental health professionals treating them. It is also
      true that many newly diagnosed borderline patients are not provided with up-to-date
      information on the disorder even though psychoeducation has been found to be a useful form of
      treatment for other serious psychiatric illnesses.

      The investigators have conducted a preliminary randomized trial of psychoeducation for BPD
      that found that those provided with immediate psychoeducation had a significantly greater
      reduction in two core symptoms of BPD--general impulsivity and stormy relationships--than
      those with delayed psychoeducation.

      However, both instruction and assessment of change over time were conducted in person by
      paraprofessionals. The importance of the current study is that it will allow the
      investigators to develop and test the efficacy of an internet-based program of
      psychoeducation for BPD that will be both cost efficient and easy to disseminate widely,
      particularly to underserved populations.
Clinical experience suggests that many people with borderline personality disorder (BPD) are
      not told of their borderline diagnosis by those treating them. Clinical experience also
      suggests that many people with newly diagnosed BPD are not provided with up-to-date
      information on the disorder. These practices are unfortunate as the results of a preliminary,
      randomized, controlled trial of psychoeducation for BPD conducted by the investigators
      suggest that informing patients about BPD soon after diagnostic disclosure may be an
      effective form of early treatment for BPD as it significantly reduced the severity of two of
      the core symptoms of borderline psychopathology-general impulsivity and unstable
      relationships.

      This application proposes building on the PI's prior work in this area by developing a
      web-based program for the education of those with BPD and the assessment of three key
      outcomes; psychoeducation and assessment of outcome that had previously been provided by a
      team of clinically experienced research assistants. Both of these initiatives would allow for
      the widespread, cost-efficient dissemination of this early form of treatment for BPD-a form
      of treatment that has proven effective for other serious psychiatric illnesses.

      The investigators first aim is to update our curriculum for teaching individuals with BPD the
      latest information concerning the disorder. This information will be organized into seven
      modules: introductory information (history of diagnosis, stigma associated with disorder, and
      demographic characteristics associated with BPD), symptoms of BPD, co-occurring disorders,
      etiology, longitudinal course, psychosocial treatments, and psychotropic medications. Some
      modules will be divided into sub-modules. For example, etiology will encompass childhood
      adversity, family history of psychiatric disorder, temperament, genetics, and other
      biological findings.

      The investigators second aim is to develop a website for teaching the most up-to-date
      information about BPD and assessing three key outcomes: the severity of borderline
      psychopathology, psychosocial impairment, and treatment utilization over time. These outcomes
      will be assessed using self-report measures with proven psychometric properties. Symptom
      severity will be accomplished through the internet-based administration of the self-report
      version of the already widely used Zanarini Rating Scale for Borderline Personality Disorder
      (ZAN-BPD)-a dimensional measure of the nine Diagnostic and Statistical Manual of Mental
      Disorders, fourth edition(DSM-IV) symptoms of BPD. The investigators will also use the
      Borderline Evaluation of Severity over Time (BEST) developed by Pfohl and Blum as a secondary
      measure of change in severity of borderline psychopathology. Two other self-report measures
      will be used to assess psychosocial impairment (Sheehan Disability Scale and Weissman's
      Social Adjustment Scale). The use of nine forms of psychiatric treatment will be assessed
      using a self-report version of the treatment section of the Background Information Schedule
      and its follow-up analog.

      The investigators third aim is to conduct a small-scale randomized controlled trial of
      psychoeducation for BPD using this set of web-based instructional and assessment tools. Half
      of the 80 subjects will be randomized to the investigators web-based intervention, which will
      occur a week after diagnostic disclosure, and half will not. The investigators plan to assess
      symptom severity, psychosocial impairment, and treatment utilization each week for 12 weeks
      (as the investigators did in our prior study) using the web-based self-report measures
      described above to determine its immediate effects. The investigators also plan to assess
      these outcomes using these measures at six months, nine months, and 12 months after
      randomization to determine if these effects are long lasting. The investigators hypothesize
      that two of the nine symptoms of DSM-IV BPD will decline significantly more in the subjects
      who receive psychoeducation than those who do not-general impulsivity and unstable
      relationships. The investigators further hypothesize that those in the treatment group will
      have more improved functioning in the social and vocational (but not family realm) than those
      in the non-treatment group. Finally, the investigators hypothesize that those receiving
      psychoeducation will be more likely to seek out ongoing psychiatric treatment and less likely
      to use emergency psychiatric services, such as hospitalizations, than those who do not
      receive psychoeducation concerning BPD.

      If successful, the results of this trial would provide further evidence that psychoeducation
      is a useful form of early treatment for BPD. These results would also suggest that our
      web-based platform is an effective and cost efficient method for delivering such a program.
      Finally, these results would pave the way for a large-scale, multi-site randomized controlled
      trial of this web-based program in community settings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Zanarini Rating Scale for Borderline Personality Disorder
time frame: Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up
description: A dimensional self-report measure of the nine DSM-IV symptoms of BPD
measure: Borderline Evaluation of Severity over Time
time frame: Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up
description: A self-report that measures change in severity of borderline psychopathology
measure: Sheehan Disability Scale
time frame: Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up
description: A self-report measure used to assess psychosocial impairment
measure: Weissman's Social Adjustment Scale
time frame: Change from baseline through weeks 4,8,12, 6 month follow-up, 9 month follow-up, 12 month follow-up
description: A self-report measure used to assess psychosocial impairment
measure: Clinically Useful Depression Outcome Scale
time frame: Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up
description: A self-report designed to assess sensitivity to change in depression symptoms
measure: Clinically Useful Anxiety Outcome Scale
time frame: Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up
description: A self-report designed to assess sensitivity to change in anxiety symptoms
arm group label: Non-Education
arm group type: Placebo Comparator
description: This group will not receive the psychosocial education.
arm group label: Education
arm group type: Active Comparator
description: This group will receive the psychosocial education
intervention type: Behavioral
intervention name: Education
description: This group will receive the psychoeducation
arm group label: Education
intervention type: Behavioral
intervention name: Non-Education
description: This group will not receive the psychoeducation
arm group label: Non-Education
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
last name: Mary C Zanarini, Ed.D.
role: Principal Investigator
affiliation: Mclean Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mclean Hospital
investigator full name: Mary Zanarini
investigator title: Professor of Psychology
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder