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/NCT05972096</url>
    </required_header>
    <id_info>
      <org_study_id>IIBSP-TLP-2020-104</org_study_id>
      <nct_id>NCT05972096</nct_id>
    </id_info>
    <brief_title>DBT Skills Expanded With Contextual Intervention for Long Lasting Symptoms in Borderline Personality Disorder</brief_title>
    <acronym>DBT+Context</acronym>
    <official_title>Clinical Trial of Skills Training for Long Lasting Symptoms in Borderline Personality Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</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>
        Although borderline personality disorder (BPD) tend to the clinical remission in long-term&#xD;
        follow-up studies, a significant subgroup of patients continues to present long lasting&#xD;
        symptoms such as low mood, emptiness and persistent impairment in psychosocial adjustment.&#xD;
        The prevalence of this subsample of individuals is considerably increasing last years. New&#xD;
        interventions addressed to these individuals are need, the aim of this study is to evaluate&#xD;
        the efficacy of a novel intervention combining dialectical behavioral therapy skills training&#xD;
        with self-compassion and contextual-based skills for patients with long-lasting BPD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sixty individuals with BPD and long lasting symptoms that have been received previously&#xD;
        dialectical-behavioral therapy skills training (DBT-ST) will be included in a randomized&#xD;
        clinical trial. They will be randomly assigned to receive an add-on skills training&#xD;
        intervention involving the combination of DBT-ST, self-compassion, and contextual-based&#xD;
        skills for long lasting symptoms versus treatment as usual during 12-weeks. Patients will be&#xD;
        evaluated pre and post intervention and 3-month follow-up. The outcome measures are&#xD;
        well-being indicators and clinical variables.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</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>Randomized clinical trial aims to test the efficacy of this expanded skills DBT-based intervention with self-compassion and contextual-based skills targeting long-lasting BPD compared with treatment as usual.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pemberton Happiness Index (PHI)</measure>
      <time_frame>1 month</time_frame>
      <description>Happiness index (minimum 0- maximum 110) Higher scores better</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Borderline Symptoms List-23 (BSL-23)</measure>
      <time_frame>1 week</time_frame>
      <description>Symptoms of Borderline (minimum 0- maximum 92). Higher scores worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Remission from Depression Questionnaire (RDQ)</measure>
      <time_frame>1 week</time_frame>
      <description>Depression (minimum 0- maximum 84). Higher scores worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self Compassion Scale Short Form (SCS-SF)</measure>
      <time_frame>1 month</time_frame>
      <description>Compassion scale (12 items, minimum 12- maximum 60). Higher scores worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale (FSCRS)</measure>
      <time_frame>1 month</time_frame>
      <description>Self-criticism forms (14 items, minimum 0- maximum 56). Higher scores worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with life scale (SWLS)</measure>
      <time_frame>1 month</time_frame>
      <description>Well being (5 items, minimum 5 - maximum 25). Higher scores better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life scale (WHO-QOL_BREF)</measure>
      <time_frame>2 weeks</time_frame>
      <description>Quality of life OMS (26 items, minimum 26- maximum 130). Higher scores better</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Borderline Personality Disorders</condition>
    <condition>BPD</condition>
    <arm_group>
      <arm_group_label>Combination of DBT-ST, self-compassion, and contextual-based skills.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Combination of DBT-ST, self-compassion, and contextual-based skills.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Treatment as usual. Although these individuals did not receive any new specific psychotherapeutic intervention for BPD, they valued the higher frequency of psychiatric visits, attention in crisis, family care, and greater experience and sensitivity in the management of BPD.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Combination DBT, self-compassion and contextual-based skills</intervention_name>
      <description>Psychotherapy combination. Skills of DBT plus self-compassion and contextual skills</description>
      <arm_group_label>Combination of DBT-ST, self-compassion, and contextual-based skills.</arm_group_label>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults between 18 and 65 years of age&#xD;
  &#xD;
            -  Primary diagnosis of BPD according to Diagnostic Statistical Manual IV criteria and by&#xD;
               the structured interviews: Diagnosis Structured clinical interview for axis II&#xD;
               personality disorders (SCID II; First et al. 1997) and Diagnostic Interview for&#xD;
               Borderlines Revised (DIB-R)&#xD;
  &#xD;
            -  Previous participation in DBT-ST intervention&#xD;
  &#xD;
            -  Signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of life-threatening behaviors in the last 12 months&#xD;
  &#xD;
            -  PTSD or related symptoms&#xD;
  &#xD;
            -  Diagnosis of drug-induced psychosis, organic brain syndrome, bipolar or psychotic&#xD;
               disorder&#xD;
  &#xD;
            -  Intellectual disability&#xD;
  &#xD;
            -  Participation in any other psychotherapy treatment during the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joaquim Soler, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Juan Carlos Pascual, PhD</last_name>
      <phone>34935537840</phone>
      <email>jpascual@santpau.cat</email>
    </overall_contact>
    <location>
      <facility>
        <name>Juan Carlos Pascual Mateos</name>
        <address>
          <city>Barcelona</city>
          <zip>08041</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Juan Carlos Pascual, PhD</last_name>
        <phone>+34935537840</phone>
        <email>jpascual@santpau.cat</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>borderline personality disorder</keyword>
    <keyword>long-lasting symptoms</keyword>
    <keyword>dialectical behavior therapy skills</keyword>
    <keyword>contextual approach.</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>
    </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/NCT05972096
  org study id: IIBSP-TLP-2020-104
  nct id: NCT05972096
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Although borderline personality disorder (BPD) tend to the clinical remission in long-term
        follow-up studies, a significant subgroup of patients continues to present long lasting
        symptoms such as low mood, emptiness and persistent impairment in psychosocial adjustment.
        The prevalence of this subsample of individuals is considerably increasing last years. New
        interventions addressed to these individuals are need, the aim of this study is to evaluate
        the efficacy of a novel intervention combining dialectical behavioral therapy skills training
        with self-compassion and contextual-based skills for patients with long-lasting BPD.
  Sixty individuals with BPD and long lasting symptoms that have been received previously
        dialectical-behavioral therapy skills training (DBT-ST) will be included in a randomized
        clinical trial. They will be randomly assigned to receive an add-on skills training
        intervention involving the combination of DBT-ST, self-compassion, and contextual-based
        skills for long lasting symptoms versus treatment as usual during 12-weeks. Patients will be
        evaluated pre and post intervention and 3-month follow-up. The outcome measures are
        well-being indicators and clinical variables.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized clinical trial aims to test the efficacy of this expanded skills DBT-based intervention with self-compassion and contextual-based skills targeting long-lasting BPD compared with treatment as usual.
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Pemberton Happiness Index (PHI)
  time frame: 1 month
  description: Happiness index (minimum 0- maximum 110) Higher scores better
  measure: Borderline Symptoms List-23 (BSL-23)
  time frame: 1 week
  description: Symptoms of Borderline (minimum 0- maximum 92). Higher scores worse
  measure: Remission from Depression Questionnaire (RDQ)
  time frame: 1 week
  description: Depression (minimum 0- maximum 84). Higher scores worse
  measure: Self Compassion Scale Short Form (SCS-SF)
  time frame: 1 month
  description: Compassion scale (12 items, minimum 12- maximum 60). Higher scores worse
  measure: Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale (FSCRS)
  time frame: 1 month
  description: Self-criticism forms (14 items, minimum 0- maximum 56). Higher scores worse
  measure: Satisfaction with life scale (SWLS)
  time frame: 1 month
  description: Well being (5 items, minimum 5 - maximum 25). Higher scores better
  measure: Quality of life scale (WHO-QOL_BREF)
  time frame: 2 weeks
  description: Quality of life OMS (26 items, minimum 26- maximum 130). Higher scores better
  arm group label: Combination of DBT-ST, self-compassion, and contextual-based skills.
  arm group type: Experimental
  description: Combination of DBT-ST, self-compassion, and contextual-based skills.
  arm group label: Control Group
  arm group type: Placebo Comparator
  description: Treatment as usual. Although these individuals did not receive any new specific psychotherapeutic intervention for BPD, they valued the higher frequency of psychiatric visits, attention in crisis, family care, and greater experience and sensitivity in the management of BPD.
  intervention type: Behavioral
  intervention name: Combination DBT, self-compassion and contextual-based skills
  description: Psychotherapy combination. Skills of DBT plus self-compassion and contextual skills
  arm group label: Combination of DBT-ST, self-compassion, and contextual-based skills.
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Joaquim Soler, PhD
  role: Principal Investigator
  affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  last name: Juan Carlos Pascual, PhD
  phone: 34935537840
  email: jpascual@santpau.cat
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Personality Disorders
  mesh term: Borderline Personality Disorder
  sharing ipd: No