<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/NCT02257996</url>
  </required_header>
  <id_info>
    <org_study_id>SBPP-1</org_study_id>
    <nct_id>NCT02257996</nct_id>
  </id_info>
  <brief_title>Effectiveness of Online Systematic Brief Psychodynamic Psychotherapy for Neurotic Disorders: Randomized Controlled Trial</brief_title>
  <official_title>The Effectiveness of Online Systematic Brief Psychodynamic Psychotherapy Via HIPAA Complaint Web Conferencing on Adults With Neurotic Disorders: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To evaluate the effectiveness of online systematic brief psychodynamic&#xD;
      psychotherapy (SBPP) via HIPAA compliant web conferencing on adults with neurotic disorders.&#xD;
&#xD;
      Design: Randomized controlled trial. Single blind.&#xD;
&#xD;
      Setting: Internet users in the community, in São Paulo, Brazil.&#xD;
&#xD;
      Participants: Thirty-two adults will be randomly allocated to a group will receive online&#xD;
      systematic brief psychodynamic psychotherapy (n=16), or a waiting list group (n=16).&#xD;
&#xD;
      Method: Systematic adaptative diagnosis system will be applied in both groups at&#xD;
      pre-treatment and post-treatment (or post-waiting list). Assessment will be a comparison of&#xD;
      the adaptative diagnosis evolution between groups.&#xD;
&#xD;
      Primary Outcomes: The subjects treated with online brief systematic psychodynamic&#xD;
      psychotherapy will present an increase in their adaptative efficacy measured by systematic&#xD;
      adaptative diagnosis scale (SADS) in comparison to the waiting list group, when contrasting&#xD;
      their initial and final adaptative diagnostics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2015</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">May 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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Systematic Adaptive Diagnosis Scale (SADS)</measure>
    <time_frame>Each participant will be followed, an expected average of 3 months.</time_frame>
    <description>Participants of interventional group will be followed for the duration of therapeutic process, an expected average of 3 months.&#xD;
Participants of control group will be followed after waiting-list period, an expected average of 3 months.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Neurotic Disorders</condition>
  <arm_group>
    <arm_group_label>Interventional Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Online Systematic Brief Psychodynamic Psychotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Waiting list</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online Systematic Brief Psychodynamic Psychotherapy</intervention_name>
    <description>Systematic Adaptative Diagnosis System will be applied in both groups at two different times: pre-treatment and post-treatment</description>
    <arm_group_label>Interventional Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Residents in Sao Paulo city,&#xD;
&#xD;
          -  Graduation complete or in course,&#xD;
&#xD;
          -  Fluent Portuguese,&#xD;
&#xD;
          -  Basic skills on english language,&#xD;
&#xD;
          -  If in psychiatric treatment, must be under treatment with stable dosage of psychiatric&#xD;
             medication for at least 6 months,&#xD;
&#xD;
          -  Participants with diagnosis of neurotic disorders (F03.650),&#xD;
&#xD;
          -  Motivation for the therapeutic process,&#xD;
&#xD;
          -  Availability for 4 months of psychotherapy,&#xD;
&#xD;
          -  A personal computer (with an IP address), a web camera, a microphone, access to a 1&#xD;
             Mbps internet connection and specific computer configuration to access the Secure&#xD;
             Psychotherapy Virtual Environment,&#xD;
&#xD;
          -  Basic knowledge of elementary internet tools,&#xD;
&#xD;
          -  A justified reason that impedes a in person psychotherapy, such as the ones below:&#xD;
&#xD;
               -  Lack of financial resources,&#xD;
&#xD;
               -  Frequent change of address due to work reasons,&#xD;
&#xD;
               -  Mobility restrictions related to accidents, illnesses or physical deficiencies,&#xD;
&#xD;
               -  Inability to arrive for psychotherapy appointments due to urban chaos.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants that present:&#xD;
&#xD;
          -  a schizophrenia diagnostic or any other severe mental illness,&#xD;
&#xD;
          -  drug and alcohol dependence that are in abstinence from substance abuse,&#xD;
&#xD;
          -  untreated diagnosis of illnesses that may cause emotional imbalance, such as thyroid&#xD;
             malfunction,&#xD;
&#xD;
          -  Participants that are undergoing a therapeutic process during the time of the&#xD;
             research,&#xD;
&#xD;
          -  Individuals with both suicidal ideation and clear intent and need emergency treatment,&#xD;
&#xD;
          -  Participants do not possess the characteristics needed to be included in the sample or&#xD;
             are bearers of deficiencies that may compromise the treatment mediated by a computer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia CA Siqueira, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claudia CA Siqueira, MSc</last_name>
    <phone>+5511985885778</phone>
    <email>claudiacatao@usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marcelo N Russo</last_name>
    <phone>+5511992029060</phone>
    <email>mrusso@casadosinsights.com.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinical Psychology Department from Institute of Psychology at University of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05508-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>Claudia CA Siqueira, MSc</last_name>
      <phone>+5511985885778</phone>
      <email>claudiacatao@usp.br</email>
    </contact>
    <contact_backup>
      <last_name>Marcelo N Russo</last_name>
      <phone>+5511992029060</phone>
      <email>mrusso@casadosinsights.com.br</email>
    </contact_backup>
    <investigator>
      <last_name>Claudia CA Siqueira, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>January 14, 2015</last_update_submitted>
  <last_update_submitted_qc>January 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Claudia Catao Alves Siqueira</investigator_full_name>
    <investigator_title>PhD researcher</investigator_title>
  </responsible_party>
  <keyword>Psychoanalytic Psychotherapy</keyword>
  <keyword>Telepsychology</keyword>
  <keyword>Online Therapy</keyword>
  <keyword>Web conferencing</keyword>
  <keyword>RCT</keyword>
  <keyword>HIPAA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurotic Disorders</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/NCT02257996
org study id: SBPP-1
nct id: NCT02257996
lead sponsor: 
has dmc: Yes
Objective: To evaluate the effectiveness of online systematic brief psychodynamic
      psychotherapy (SBPP) via HIPAA compliant web conferencing on adults with neurotic disorders.

      Design: Randomized controlled trial. Single blind.

      Setting: Internet users in the community, in São Paulo, Brazil.

      Participants: Thirty-two adults will be randomly allocated to a group will receive online
      systematic brief psychodynamic psychotherapy (n=16), or a waiting list group (n=16).

      Method: Systematic adaptative diagnosis system will be applied in both groups at
      pre-treatment and post-treatment (or post-waiting list). Assessment will be a comparison of
      the adaptative diagnosis evolution between groups.

      Primary Outcomes: The subjects treated with online brief systematic psychodynamic
      psychotherapy will present an increase in their adaptative efficacy measured by systematic
      adaptative diagnosis scale (SADS) in comparison to the waiting list group, when contrasting
      their initial and final adaptative diagnostics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Systematic Adaptive Diagnosis Scale (SADS)
time frame: Each participant will be followed, an expected average of 3 months.
description: Participants of interventional group will be followed for the duration of therapeutic process, an expected average of 3 months.
Participants of control group will be followed after waiting-list period, an expected average of 3 months.
arm group label: Interventional Group
arm group type: Experimental
description: Online Systematic Brief Psychodynamic Psychotherapy
arm group label: Control Group
arm group type: No Intervention
description: Waiting list
intervention type: Behavioral
intervention name: Online Systematic Brief Psychodynamic Psychotherapy
description: Systematic Adaptative Diagnosis System will be applied in both groups at two different times: pre-treatment and post-treatment
arm group label: Interventional Group
criteria: 
gender: All
minimum age: 22 Years
maximum age: 65 Years
healthy volunteers: No
last name: Claudia CA Siqueira, MSc
role: Principal Investigator
affiliation: University of Sao Paulo
last name: Claudia CA Siqueira, MSc
phone: +5511985885778
email: claudiacatao@usp.br
last name: Marcelo N Russo
phone: +5511992029060
email: mrusso@casadosinsights.com.br
facility: 
contact: 
contact backup: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Claudia Catao Alves Siqueira
investigator title: PhD researcher
mesh term: Neurotic Disorders