<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/NCT04493580</url>
  </required_header>
  <id_info>
    <org_study_id>PSIY-391-13</org_study_id>
    <nct_id>NCT04493580</nct_id>
  </id_info>
  <brief_title>DBT Techniques by E-mail for Patients With BPD</brief_title>
  <official_title>Effectiveness of Delivering Dialectical Behavioral Therapy Techniques by E-mail in Patients With Borderline Personality Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Online PsychoTherapy Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen's University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Purpose: The aim of the current study was to evaluate the efficacy of online Dialectical&#xD;
      Behavioural Therapy (e-DBT) in the treatment of individuals with symptoms of borderline&#xD;
      personality disorder (BPD). Method: Study participants diagnosed with BPD were offered&#xD;
      treatment options of either online or in-person format of a DBT skills-building program.&#xD;
      During each session, participants were provided with both the material and feedback regarding&#xD;
      their previous week's homework. e-DBT protocol and content was designed to mirror in-person&#xD;
      content. Participants were assessed by using a Self-Assessment Questionnaire (SAQ) and&#xD;
      Difficulties in Emotion Regulation Scale (DERS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dialectal Behavioural Therapy: Since 1995, the Personality Disorders Service in Kingston,&#xD;
      Ontario, Canada, has developed psychotherapeutic programs that have integrated a range of&#xD;
      modalities for the treatment of individuals presenting with borderline personality disorders.&#xD;
      Currently, a range of therapy groups is offered, including a weekly skills-building group&#xD;
      that is structured to offer the basic DBT curriculum, titled Managing Powerful Emotions&#xD;
      (MPE). This MPE curriculum includes Mindfulness, Distress Tolerance, Emotion Regulation, and&#xD;
      Interpersonal Effectiveness. MPE has been offered since 2000 as a first-line treatment for&#xD;
      individuals who are diagnosed with BPD. The Personality Disorders Service offers more&#xD;
      advanced therapy groups for individuals who have completed the MPE and wish to continue&#xD;
      seeking treatment modalities. One of the most intensive therapy programs offered is the&#xD;
      Chrysalis Day Treatment Program (CDTP). To participate in the CDTP, an individual must&#xD;
      progress through two prior phases. In phase one, individuals will participate in a&#xD;
      DBT-informed skill-building group (MPE). Once completed, the individual will progress to&#xD;
      phase two which includes attending a psychotherapy group, incorporating DBT skills-building.&#xD;
      Finally, in phase three, individuals who wish to participate in a more advanced and complex&#xD;
      psychological treatment program, apply to participate in CDTP. The CDTP is an intensive day&#xD;
      treatment program integrating DBT skills-building, psychodynamic psychotherapy, and a range&#xD;
      of other group therapy modalities. This integrated form of psychotherapy is extremely&#xD;
      effective, especially for individuals suffering from more severe and prolonged symptomatology&#xD;
      and trauma histories.&#xD;
&#xD;
      Recruitment: Individuals who were referred to the Personality Disorders Service in Kingston,&#xD;
      Ontario, Canada, with a diagnosis of BPD by a psychiatrist or family physician were offered&#xD;
      the opportunity to either select in-person DBT skills-building program groups (MPE) or an&#xD;
      online format of the program (iDBT). Inclusion criteria included participants being between&#xD;
      the ages of 18 and 65 years at study inception, a diagnosis of borderline personality&#xD;
      disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition&#xD;
      (DSM-5) guidelines. Moreover, participants were required to have the competence to consent&#xD;
      and participate, the ability to speak and read English, and have consistent and reliable&#xD;
      access to the internet. Participants were excluded from the study if they were experiencing&#xD;
      acute hypomanic or manic episodes, acute psychosis, severe alcohol or substance use disorder,&#xD;
      or were currently receiving DBT. Individuals who were referred to the program were provided&#xD;
      with an information sheet about the study comparing the effectiveness of online treatment to&#xD;
      in-person treatment, and those who consented were included in the study. The in-person group&#xD;
      served as a control group.&#xD;
&#xD;
      Measurement Scales: Each individual participating in the study completed a pre- and&#xD;
      post-program Self-Assessment Questionnaire (SAQ) and Difficulties in Emotion Regulation Scale&#xD;
      (DERS) (Weiss, Gratz, &amp; Lavender, 2015). The DERS is a self-report tool designed to obtain an&#xD;
      overall measure of the difficulty respondents have with various aspects of emotion&#xD;
      regulation. The DERS not only provides an overall score of difficulties with emotion&#xD;
      regulation but assesses the following six specific factors related to emotion dysregulation:&#xD;
      non-acceptance (non-acceptance of emotional responses), goals (difficulty engaging in&#xD;
      goal-oriented behaviours), impulse (difficulty controlling impulses), awareness (lack of&#xD;
      emotional awareness), strategies (lack of access to emotion regulation strategies) and&#xD;
      clarity (lack of emotional clarity). It was explained to all participants on the consent form&#xD;
      and also as part of the first session of both the in-person and electronic groups that the&#xD;
      program was created for helping individuals to learn useful skills and strategies for&#xD;
      managing their emotions and behaviours, and that it was not a crisis service. iDBT&#xD;
      participants were informed that their online therapist would read their emails once a week&#xD;
      and thus would not be in a position to respond to crises, such as suicidal impulses or&#xD;
      behaviours. Participants were informed that in the case of an emergency, they were to either&#xD;
      attend their local emergency department, call emergency services, or call their local crisis&#xD;
      line.&#xD;
&#xD;
      Therapy Programs: The therapy program had a duration of 15 weeks, with one DBT session per&#xD;
      week. During each online session, participants were individually sent approximately 30-40&#xD;
      PowerPoint slides. These slides included general information on a particular topic, an&#xD;
      overview of skills related to the issue being covered, and homework sheets to be completed&#xD;
      and returned to their therapists. Therapists involved were a psychiatry resident, a&#xD;
      psychologist, and a registered nurse who also facilitated the in-person groups. The content&#xD;
      and format of the online program directly corresponded with that of the in-person group.&#xD;
      Participants in the online program were asked to send their homework sheets back to the&#xD;
      therapists by a specific day each week. The following day, the therapist would email&#xD;
      individualized feedback regarding the homework submitted and send the next week's PowerPoint&#xD;
      slides, information sheets, and homework. To be eligible to receive the next week's&#xD;
      materials, participants were required to send in their homework before the deadline. If the&#xD;
      homework was not returned, a reminder email was sent. If more than two sessions were missed,&#xD;
      participants were excluded from the program.&#xD;
&#xD;
      Ethical Considerations and Confidentiality: Only the therapists involved in the patients'&#xD;
      care had access to the participants' information. The data for variables under study were&#xD;
      entered anonymously into a database separate from the clinical file. This study was approved&#xD;
      by the Research and Ethics Board of Queen's University, Canada.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2014</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Individuals who were referred to the Personality Disorders Service in Kingston, Ontario, Canada, with a diagnosis of BPD by a psychiatrist or family physician were offered the opportunity to either select in-person DBT skills-building program groups (MPE) or an online format of the program (iDBT).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-Assessment Questionnaire (SAQ) Changes</measure>
    <time_frame>Week 1, Week 15</time_frame>
    <description>Self assessment questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difficulties in Emotion Regulation Scale (DERS) Changes</measure>
    <time_frame>Week 1, Week 15</time_frame>
    <description>Self-report tool designed to obtain an overall measure of the difficulty respondents have with various aspects of emotion regulation. The DERS not only provides an overall score of difficulties with emotion regulation, but assesses the following six specific factors related to emotion dysregulation: non-acceptance (non-acceptance of emotional responses), goals (difficulty engaging in goal-oriented behaviors), impulse (difficulty controlling impulses), awareness (lack of emotional awareness), strategies (lack of access to emotion regulation strategies) and clarity (lack of emotional clarity).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Borderline Personality Disorder</condition>
  <arm_group>
    <arm_group_label>iDBT Treatments</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 weekly DBT sessions. During each session, participants will be sent 30-40 PowerPoint slides including general information on particular topic, overview of skills, and homework sheets to be completed and returned to therapists. Therapists involved will be a psychiatry resident, a psychologist, and a registered nurse who will also facilitate the in-person groups. The content and format of the online program will directly corresponded with that of the in-person group. Participants will be asked to send their homework sheets back to therapists by a specific day each week. The following day, the therapist will email feedback regarding the homework submitted and send next week's PowerPoint slides, information sheets, and homework. In order to be eligible to receive the materials, participants are required to send in homework prior to deadline. If homework was not returned, reminder email will be sent. If more than two sessions are missed, participants are excluded from the program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-Person DBT Treatments</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Weekly skills-building groups titled Managing Powerful Emotions (MPE) includes Mindfulness, Distress Tolerance, Emotion Regulation, and Interpersonal Effectiveness. Personality Disorders Service offers more advanced therapy groups for individuals who have successfully completed MPE and wish to continue seeking treatment modalities. Chrysalis Day Treatment Program (CDTP) is for an individual who has progress through two prior phases. In phase one, individuals will participate in a DBT-informed skill-building group (MPE). Once completed, the individual will progress to phase two which includes attending a psychotherapy group, incorporating DBT skills-building. Finally, in phase three, individuals who wish to participate in a more advanced and complex psychological treatment program, apply to participate in CDTP. The CDTP is an intensive day treatment program integrating DBT skills-building, psychodynamic psychotherapy, and a range of other group therapy modalities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>iDBT</intervention_name>
    <description>Electronic DBT sessions designed to mirror in-person DBT.</description>
    <arm_group_label>iDBT Treatments</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>In-Person DBT</intervention_name>
    <description>In-person DBT</description>
    <arm_group_label>In-Person DBT Treatments</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Borderline Personality Disorder Diagnosis via DSM-5 Guidelines&#xD;
&#xD;
          -  Competence to consent and participate&#xD;
&#xD;
          -  Ability to speak and read English&#xD;
&#xD;
          -  Consistent and reliable access to the internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute hypomanic/manic episodes&#xD;
&#xD;
          -  Acute psychosis&#xD;
&#xD;
          -  Severe alcohol or substance use disorder&#xD;
&#xD;
          -  Currently receiving DBT&#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>Nazanin Alavi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen's University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hotel Dieu Hospital</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 5G3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University</investigator_affiliation>
    <investigator_full_name>Dr. Nazanin Alavi</investigator_full_name>
    <investigator_title>Principal Investigator, Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Borderline Personality Disorder</keyword>
  <keyword>Treatment</keyword>
  <keyword>Barriers to Treatment</keyword>
  <keyword>Psychotherapy</keyword>
  <keyword>Dialectal Behavioural Therapy</keyword>
  <keyword>Online</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>Only the therapists involved in the patients' care had access to the participants' information. The data for variables under study were entered anonymously into a database separate from the clinical file. This study was approved by the Research and Ethics Board of Queen's University, Canada.</ipd_description>
  </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/NCT04493580
org study id: PSIY-391-13
nct id: NCT04493580
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose: The aim of the current study was to evaluate the efficacy of online Dialectical
      Behavioural Therapy (e-DBT) in the treatment of individuals with symptoms of borderline
      personality disorder (BPD). Method: Study participants diagnosed with BPD were offered
      treatment options of either online or in-person format of a DBT skills-building program.
      During each session, participants were provided with both the material and feedback regarding
      their previous week's homework. e-DBT protocol and content was designed to mirror in-person
      content. Participants were assessed by using a Self-Assessment Questionnaire (SAQ) and
      Difficulties in Emotion Regulation Scale (DERS).
Dialectal Behavioural Therapy: Since 1995, the Personality Disorders Service in Kingston,
      Ontario, Canada, has developed psychotherapeutic programs that have integrated a range of
      modalities for the treatment of individuals presenting with borderline personality disorders.
      Currently, a range of therapy groups is offered, including a weekly skills-building group
      that is structured to offer the basic DBT curriculum, titled Managing Powerful Emotions
      (MPE). This MPE curriculum includes Mindfulness, Distress Tolerance, Emotion Regulation, and
      Interpersonal Effectiveness. MPE has been offered since 2000 as a first-line treatment for
      individuals who are diagnosed with BPD. The Personality Disorders Service offers more
      advanced therapy groups for individuals who have completed the MPE and wish to continue
      seeking treatment modalities. One of the most intensive therapy programs offered is the
      Chrysalis Day Treatment Program (CDTP). To participate in the CDTP, an individual must
      progress through two prior phases. In phase one, individuals will participate in a
      DBT-informed skill-building group (MPE). Once completed, the individual will progress to
      phase two which includes attending a psychotherapy group, incorporating DBT skills-building.
      Finally, in phase three, individuals who wish to participate in a more advanced and complex
      psychological treatment program, apply to participate in CDTP. The CDTP is an intensive day
      treatment program integrating DBT skills-building, psychodynamic psychotherapy, and a range
      of other group therapy modalities. This integrated form of psychotherapy is extremely
      effective, especially for individuals suffering from more severe and prolonged symptomatology
      and trauma histories.

      Recruitment: Individuals who were referred to the Personality Disorders Service in Kingston,
      Ontario, Canada, with a diagnosis of BPD by a psychiatrist or family physician were offered
      the opportunity to either select in-person DBT skills-building program groups (MPE) or an
      online format of the program (iDBT). Inclusion criteria included participants being between
      the ages of 18 and 65 years at study inception, a diagnosis of borderline personality
      disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
      (DSM-5) guidelines. Moreover, participants were required to have the competence to consent
      and participate, the ability to speak and read English, and have consistent and reliable
      access to the internet. Participants were excluded from the study if they were experiencing
      acute hypomanic or manic episodes, acute psychosis, severe alcohol or substance use disorder,
      or were currently receiving DBT. Individuals who were referred to the program were provided
      with an information sheet about the study comparing the effectiveness of online treatment to
      in-person treatment, and those who consented were included in the study. The in-person group
      served as a control group.

      Measurement Scales: Each individual participating in the study completed a pre- and
      post-program Self-Assessment Questionnaire (SAQ) and Difficulties in Emotion Regulation Scale
      (DERS) (Weiss, Gratz, & Lavender, 2015). The DERS is a self-report tool designed to obtain an
      overall measure of the difficulty respondents have with various aspects of emotion
      regulation. The DERS not only provides an overall score of difficulties with emotion
      regulation but assesses the following six specific factors related to emotion dysregulation:
      non-acceptance (non-acceptance of emotional responses), goals (difficulty engaging in
      goal-oriented behaviours), impulse (difficulty controlling impulses), awareness (lack of
      emotional awareness), strategies (lack of access to emotion regulation strategies) and
      clarity (lack of emotional clarity). It was explained to all participants on the consent form
      and also as part of the first session of both the in-person and electronic groups that the
      program was created for helping individuals to learn useful skills and strategies for
      managing their emotions and behaviours, and that it was not a crisis service. iDBT
      participants were informed that their online therapist would read their emails once a week
      and thus would not be in a position to respond to crises, such as suicidal impulses or
      behaviours. Participants were informed that in the case of an emergency, they were to either
      attend their local emergency department, call emergency services, or call their local crisis
      line.

      Therapy Programs: The therapy program had a duration of 15 weeks, with one DBT session per
      week. During each online session, participants were individually sent approximately 30-40
      PowerPoint slides. These slides included general information on a particular topic, an
      overview of skills related to the issue being covered, and homework sheets to be completed
      and returned to their therapists. Therapists involved were a psychiatry resident, a
      psychologist, and a registered nurse who also facilitated the in-person groups. The content
      and format of the online program directly corresponded with that of the in-person group.
      Participants in the online program were asked to send their homework sheets back to the
      therapists by a specific day each week. The following day, the therapist would email
      individualized feedback regarding the homework submitted and send the next week's PowerPoint
      slides, information sheets, and homework. To be eligible to receive the next week's
      materials, participants were required to send in their homework before the deadline. If the
      homework was not returned, a reminder email was sent. If more than two sessions were missed,
      participants were excluded from the program.

      Ethical Considerations and Confidentiality: Only the therapists involved in the patients'
      care had access to the participants' information. The data for variables under study were
      entered anonymously into a database separate from the clinical file. This study was approved
      by the Research and Ethics Board of Queen's University, Canada.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Individuals who were referred to the Personality Disorders Service in Kingston, Ontario, Canada, with a diagnosis of BPD by a psychiatrist or family physician were offered the opportunity to either select in-person DBT skills-building program groups (MPE) or an online format of the program (iDBT).
primary purpose: Treatment
masking: None (Open Label)
measure: Self-Assessment Questionnaire (SAQ) Changes
time frame: Week 1, Week 15
description: Self assessment questionnaire
measure: Difficulties in Emotion Regulation Scale (DERS) Changes
time frame: Week 1, Week 15
description: Self-report tool designed to obtain an overall measure of the difficulty respondents have with various aspects of emotion regulation. The DERS not only provides an overall score of difficulties with emotion regulation, but assesses the following six specific factors related to emotion dysregulation: non-acceptance (non-acceptance of emotional responses), goals (difficulty engaging in goal-oriented behaviors), impulse (difficulty controlling impulses), awareness (lack of emotional awareness), strategies (lack of access to emotion regulation strategies) and clarity (lack of emotional clarity).
arm group label: iDBT Treatments
arm group type: Experimental
description: 15 weekly DBT sessions. During each session, participants will be sent 30-40 PowerPoint slides including general information on particular topic, overview of skills, and homework sheets to be completed and returned to therapists. Therapists involved will be a psychiatry resident, a psychologist, and a registered nurse who will also facilitate the in-person groups. The content and format of the online program will directly corresponded with that of the in-person group. Participants will be asked to send their homework sheets back to therapists by a specific day each week. The following day, the therapist will email feedback regarding the homework submitted and send next week's PowerPoint slides, information sheets, and homework. In order to be eligible to receive the materials, participants are required to send in homework prior to deadline. If homework was not returned, reminder email will be sent. If more than two sessions are missed, participants are excluded from the program.
arm group label: In-Person DBT Treatments
arm group type: Active Comparator
description: Weekly skills-building groups titled Managing Powerful Emotions (MPE) includes Mindfulness, Distress Tolerance, Emotion Regulation, and Interpersonal Effectiveness. Personality Disorders Service offers more advanced therapy groups for individuals who have successfully completed MPE and wish to continue seeking treatment modalities. Chrysalis Day Treatment Program (CDTP) is for an individual who has progress through two prior phases. In phase one, individuals will participate in a DBT-informed skill-building group (MPE). Once completed, the individual will progress to phase two which includes attending a psychotherapy group, incorporating DBT skills-building. Finally, in phase three, individuals who wish to participate in a more advanced and complex psychological treatment program, apply to participate in CDTP. The CDTP is an intensive day treatment program integrating DBT skills-building, psychodynamic psychotherapy, and a range of other group therapy modalities.
intervention type: Behavioral
intervention name: iDBT
description: Electronic DBT sessions designed to mirror in-person DBT.
arm group label: iDBT Treatments
intervention type: Behavioral
intervention name: In-Person DBT
description: In-person DBT
arm group label: In-Person DBT Treatments
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nazanin Alavi
role: Principal Investigator
affiliation: Queen's University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Queen's University
investigator full name: Dr. Nazanin Alavi
investigator title: Principal Investigator, Assistant Professor
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder
sharing ipd: No
ipd description: Only the therapists involved in the patients' care had access to the participants' information. The data for variables under study were entered anonymously into a database separate from the clinical file. This study was approved by the Research and Ethics Board of Queen's University, Canada.