<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/NCT03011190</url>
  </required_header>
  <id_info>
    <org_study_id>shs-ico-2015-01</org_study_id>
    <nct_id>NCT03011190</nct_id>
  </id_info>
  <brief_title>Effectiveness of the Iconic Therapy for Borderline Personality Disorder Symptoms</brief_title>
  <official_title>Effectiveness of the Iconic Therapy in Youth With Suicidal Ideation/Self-injuring Behavior and Borderline Personality Traits: Study Protocol for a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Silvia Elisa Hurtado Santiago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaga</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Borderline personality disorder (BPD) is the most prevalent personality disorder in young&#xD;
      community population whose most severe complication is suicide. Pharmacotherapy should not be&#xD;
      used as the primary treatment for BPD as the benefits are unclear. Psychotherapy is the main&#xD;
      treatment for people with BPD and the current recommendation is adapting available&#xD;
      comprehensive treatments to develop easier and briefer therapies that are also effective.&#xD;
      Iconic Therapy is an innovative option whose good clinical results should be validated on a&#xD;
      clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Borderline Personality Disorder (BPD) in the early adulthood is an increasing diagnosis among&#xD;
      general population. First symptoms detection and early intervention might help prevent its&#xD;
      aggravation and further BPD diagnosis. Iconic Therapy is an innovative manual-driven&#xD;
      psychotherapy to specifically and intensively treat BPD symptoms. Preliminary clinical&#xD;
      results are good. The aim of the present study is to assess the effectiveness of the Iconic&#xD;
      Therapy in comparison to a support structured therapy in an ecological setting (Spanish&#xD;
      public specialized mental health care). The study is planned as a randomized controlled&#xD;
      prospective trial that will randomize 60 young people (15 to 25 years old) with suicidal&#xD;
      ideation/self-injuring behaviour and borderline personality traits. Participants will be&#xD;
      randomly assigned to one of the two groups: Iconic Therapy or support structured therapy on a&#xD;
      1:1 basis. Both the Iconic Therapy and the support therapy programs consist of 10-12 weekly&#xD;
      sessions delivered by two trained psychologists for about 8-12 outpatients on group format.&#xD;
      The primary outcome measure is the change of symptoms severity assessed by the Borderline&#xD;
      Personality Disorder List (BSL-23). Secondary outcomes include suicidal ideation and&#xD;
      behavior, non-suicidal self-injures maladjustment to the daily life and economic evaluation&#xD;
      for health care. Assessments will be performed at baseline after the intervention 6 and 12&#xD;
      months of follow-up. It is hypothesized that those attending the Iconic Therapy group will&#xD;
      show a permanently reduction of the severity of symptoms as compared with those attending the&#xD;
      structured support group. Data will be analyzed using generalized estimating equations (GEE)&#xD;
      models.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23).</measure>
    <time_frame>Baseline and up to 12 months after inclusion.</time_frame>
    <description>This questionnaire (BSL-23) is a dimensional instrument: the most widely used to assess borderline personality disorder symptomatology improvement in clinical trials. The Spanish validated version of the questionnaire will be used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sociodemographic variables</measure>
    <time_frame>Baseline</time_frame>
    <description>The following socio-demographic data will be collected: gender, age, marital status, parents´nationality, coexistence (no studies, primary studies, Secondary studies, University, Professional formation), occupation (student, working, both studying and working, pensioner) and family member or allied friend´s phone number for further contacts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on the suicidal ideation and behavior measured by the Columbia Suicide History Form (SSRS).</measure>
    <time_frame>Baseline and up to 12 months after inclusion.</time_frame>
    <description>this instrument measures ideation (wish, thinking, intention and plan), ideation severity (frequency, duration, control capacity, disuasory elements and reasons) and suicidal behavior (attempts and acts). It is considered an adequate tool for treatment planning and research.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on non-suicidal self-injure diagnosis</measure>
    <time_frame>Baseline and up to 12 months after inclusion.</time_frame>
    <description>It does not exist a specific validated scale to assess non suicidal self injures so the investigators collected and asked about all the 6 Diagnostic and Statistical Manual (DSM-V) criteria. The investigators aim to separately describe the incidence of suicide attempts/acts vs non suicidal self injures in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on the economic evaluation measured by the Client Service Receipt Inventory (CSRI) - adapted Spanish version (CSRI-Spanish version)</measure>
    <time_frame>Baseline and up to 12 months after inclusion.</time_frame>
    <description>Questionnaire to assess use of healthcare/social care services and other economic impacts. This instrument has two subscales to assess either direct costs (emergency services/hospital admissions use, specialised medical consultations, prescribed diagnosis trials and consumed medication) or indirect costs (absenteeism and quantity/quality of job performance on a 100-point scales).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change on the maladjustment to the daily life measured by the Maladjustment Scale (EI).</measure>
    <time_frame>Baseline and up to 12 months after inclusion.</time_frame>
    <description>It is a brief instrument of 6 self-report items assessing maladjustment to the daily life on psychiatric population. A six point Likert scale ranging from 0 (not at all) to 5 (very strong) is used. It is sensitive to therapeutic changes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with the treatment assessed by the Opinion of treatment scale (OTS).</measure>
    <time_frame>Through therapy completion, an average of 12 weeks.</time_frame>
    <description>It is a quick and easy to administer 6-item scale for assessing satisfaction and rationale credibility : how believable, convincing and logical the treatment was from 0 (not at all) to 10 (very strong).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change on the perceived subjective global improvement measured on a 7-point ad hoc Likert scale</measure>
    <time_frame>Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion</time_frame>
    <description>Participants will be asked about their subjective impression : much/quite/little bit better, the same or much/quite/little bit worse compared to when they entered the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change on family and friends´ perceived global improvement</measure>
    <time_frame>Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion</time_frame>
    <description>Family and friend´s perceived global improvement will be asked on a 7-point ad hoc Likert scale: much/quite/little bit better, the same or much/quite/little bit worse compared to when they entered the study.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Personality Disorder, Borderline</condition>
  <arm_group>
    <arm_group_label>Iconic Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Iconic Therapy program consists of two parts: a) an intensive program of 10-12-week basic skills group 60-minute duration with a range of 6 to 8 face-to-face inserted sessions and b) an additional one-year program of 4 to 6 gradually less frequent face-to-face sessions. The groups are typically lead by two trainers -therapist and co-therapist- for about 8-12 outpatients. Added to these established sessions, a variable number of face-to-face individual sessions with the principal investigator will also take place. They will depend on participant´s requirements. They will consist on coaching their demands and providing human support throughout the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Support therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Support therapy consist of 10-12 weekly group sessions of 60-minute duration. Patients and trainers will learn and debate about different behavioral aspects of the borderline personality disorder: emotional instability and impulses control, Jacobson relaxation technique, self-image and communicational styles, mindfulness, self-esteem or social skills to name a few. The groups are typically lead by two trainers -therapist and co-therapist- for about 8-12 outpatients.Added to these established group sessions, a variable number of face-to-face individual sessions with the principal investigator will also take place. They will depend on participant´s requirements. They will consist on coaching their demands and providing human support throughout the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emotional regulation</intervention_name>
    <description>Educate people with difficulty in regulating their emotions and help them acquire skills to do so</description>
    <arm_group_label>Iconic Therapy</arm_group_label>
    <arm_group_label>Support therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 15-25 years old&#xD;
&#xD;
          -  Suicidal ideation and/or self-injuring behavior&#xD;
&#xD;
          -  BPD behavioural trends defined as the cut point for alarming BPD traits (&gt;38 score) on&#xD;
             Exploratory Questionnaire of Personality-III-BPD (CEPER-III-BPD)&#xD;
&#xD;
          -  Sufficiently proficient in Spanish to follow the treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Antisocial personality disorder as measured in the Clinical Interview for Diagnostic&#xD;
             and Statistical Manual (DSM-IV Axis II) (SCID-II)&#xD;
&#xD;
          -  Substance or alcohol abuse&#xD;
&#xD;
          -  High suicidal risk&#xD;
&#xD;
          -  Negative expectations to be enrolled in the study as measured &lt; 35 by the Expectation&#xD;
             of Treatment Scale (ETS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosa Bersabé, Psychologist</last_name>
    <role>Study Chair</role>
    <affiliation>Malaga University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fermín Mayoral, Psychiatrist</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Regional de Malaga</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Silvia E. Hurtado-Santiago</name>
      <address>
        <city>Malaga</city>
        <zip>29190</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>May 13, 2018</last_update_submitted>
  <last_update_submitted_qc>May 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaga</investigator_affiliation>
    <investigator_full_name>Silvia Elisa Hurtado Santiago</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Terapia Iconica</keyword>
  <keyword>BPD</keyword>
  <keyword>adolescence</keyword>
  <keyword>suicide</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>Undecided</sharing_ipd>
  </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/NCT03011190
org study id: shs-ico-2015-01
nct id: NCT03011190
lead sponsor: 
has dmc: No
Borderline personality disorder (BPD) is the most prevalent personality disorder in young
      community population whose most severe complication is suicide. Pharmacotherapy should not be
      used as the primary treatment for BPD as the benefits are unclear. Psychotherapy is the main
      treatment for people with BPD and the current recommendation is adapting available
      comprehensive treatments to develop easier and briefer therapies that are also effective.
      Iconic Therapy is an innovative option whose good clinical results should be validated on a
      clinical trial.
Borderline Personality Disorder (BPD) in the early adulthood is an increasing diagnosis among
      general population. First symptoms detection and early intervention might help prevent its
      aggravation and further BPD diagnosis. Iconic Therapy is an innovative manual-driven
      psychotherapy to specifically and intensively treat BPD symptoms. Preliminary clinical
      results are good. The aim of the present study is to assess the effectiveness of the Iconic
      Therapy in comparison to a support structured therapy in an ecological setting (Spanish
      public specialized mental health care). The study is planned as a randomized controlled
      prospective trial that will randomize 60 young people (15 to 25 years old) with suicidal
      ideation/self-injuring behaviour and borderline personality traits. Participants will be
      randomly assigned to one of the two groups: Iconic Therapy or support structured therapy on a
      1:1 basis. Both the Iconic Therapy and the support therapy programs consist of 10-12 weekly
      sessions delivered by two trained psychologists for about 8-12 outpatients on group format.
      The primary outcome measure is the change of symptoms severity assessed by the Borderline
      Personality Disorder List (BSL-23). Secondary outcomes include suicidal ideation and
      behavior, non-suicidal self-injures maladjustment to the daily life and economic evaluation
      for health care. Assessments will be performed at baseline after the intervention 6 and 12
      months of follow-up. It is hypothesized that those attending the Iconic Therapy group will
      show a permanently reduction of the severity of symptoms as compared with those attending the
      structured support group. Data will be analyzed using generalized estimating equations (GEE)
      models.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23).
time frame: Baseline and up to 12 months after inclusion.
description: This questionnaire (BSL-23) is a dimensional instrument: the most widely used to assess borderline personality disorder symptomatology improvement in clinical trials. The Spanish validated version of the questionnaire will be used.
measure: Sociodemographic variables
time frame: Baseline
description: The following socio-demographic data will be collected: gender, age, marital status, parents´nationality, coexistence (no studies, primary studies, Secondary studies, University, Professional formation), occupation (student, working, both studying and working, pensioner) and family member or allied friend´s phone number for further contacts.
measure: Change on the suicidal ideation and behavior measured by the Columbia Suicide History Form (SSRS).
time frame: Baseline and up to 12 months after inclusion.
description: this instrument measures ideation (wish, thinking, intention and plan), ideation severity (frequency, duration, control capacity, disuasory elements and reasons) and suicidal behavior (attempts and acts). It is considered an adequate tool for treatment planning and research.
measure: Change on non-suicidal self-injure diagnosis
time frame: Baseline and up to 12 months after inclusion.
description: It does not exist a specific validated scale to assess non suicidal self injures so the investigators collected and asked about all the 6 Diagnostic and Statistical Manual (DSM-V) criteria. The investigators aim to separately describe the incidence of suicide attempts/acts vs non suicidal self injures in this study.
measure: Change on the economic evaluation measured by the Client Service Receipt Inventory (CSRI) - adapted Spanish version (CSRI-Spanish version)
time frame: Baseline and up to 12 months after inclusion.
description: Questionnaire to assess use of healthcare/social care services and other economic impacts. This instrument has two subscales to assess either direct costs (emergency services/hospital admissions use, specialised medical consultations, prescribed diagnosis trials and consumed medication) or indirect costs (absenteeism and quantity/quality of job performance on a 100-point scales).
measure: Change on the maladjustment to the daily life measured by the Maladjustment Scale (EI).
time frame: Baseline and up to 12 months after inclusion.
description: It is a brief instrument of 6 self-report items assessing maladjustment to the daily life on psychiatric population. A six point Likert scale ranging from 0 (not at all) to 5 (very strong) is used. It is sensitive to therapeutic changes.
measure: Satisfaction with the treatment assessed by the Opinion of treatment scale (OTS).
time frame: Through therapy completion, an average of 12 weeks.
description: It is a quick and easy to administer 6-item scale for assessing satisfaction and rationale credibility : how believable, convincing and logical the treatment was from 0 (not at all) to 10 (very strong).
measure: Change on the perceived subjective global improvement measured on a 7-point ad hoc Likert scale
time frame: Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion
description: Participants will be asked about their subjective impression : much/quite/little bit better, the same or much/quite/little bit worse compared to when they entered the study.
measure: Change on family and friends´ perceived global improvement
time frame: Through therapy completion (an average of 12 weeks) and up to 12 months after inclusion
description: Family and friend´s perceived global improvement will be asked on a 7-point ad hoc Likert scale: much/quite/little bit better, the same or much/quite/little bit worse compared to when they entered the study.
arm group label: Iconic Therapy
arm group type: Experimental
description: The Iconic Therapy program consists of two parts: a) an intensive program of 10-12-week basic skills group 60-minute duration with a range of 6 to 8 face-to-face inserted sessions and b) an additional one-year program of 4 to 6 gradually less frequent face-to-face sessions. The groups are typically lead by two trainers -therapist and co-therapist- for about 8-12 outpatients. Added to these established sessions, a variable number of face-to-face individual sessions with the principal investigator will also take place. They will depend on participant´s requirements. They will consist on coaching their demands and providing human support throughout the study.
arm group label: Support therapy
arm group type: Active Comparator
description: Support therapy consist of 10-12 weekly group sessions of 60-minute duration. Patients and trainers will learn and debate about different behavioral aspects of the borderline personality disorder: emotional instability and impulses control, Jacobson relaxation technique, self-image and communicational styles, mindfulness, self-esteem or social skills to name a few. The groups are typically lead by two trainers -therapist and co-therapist- for about 8-12 outpatients.Added to these established group sessions, a variable number of face-to-face individual sessions with the principal investigator will also take place. They will depend on participant´s requirements. They will consist on coaching their demands and providing human support throughout the study.
intervention type: Behavioral
intervention name: Emotional regulation
description: Educate people with difficulty in regulating their emotions and help them acquire skills to do so
arm group label: Iconic Therapy
arm group label: Support therapy
criteria: 
gender: All
minimum age: 15 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rosa Bersabé, Psychologist
role: Study Chair
affiliation: Malaga University
last name: Fermín Mayoral, Psychiatrist
role: Study Director
affiliation: Hospital Regional de Malaga
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: University of Malaga
investigator full name: Silvia Elisa Hurtado Santiago
investigator title: Principal investigator
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder
sharing ipd: Undecided