<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/NCT02973932</url>
  </required_header>
  <id_info>
    <org_study_id>F.1331477</org_study_id>
    <nct_id>NCT02973932</nct_id>
  </id_info>
  <brief_title>iCBT for Children and Adolescents With Obsessive-compulsive Disorder</brief_title>
  <official_title>Internet-based Cognitive Behavioral Psychotherapy for Children and Adolescents With Obsessive-compulsive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</source>
  <brief_summary>
    <textblock>
      Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms&#xD;
      and an age of 7 to 17 years. Sessions are verified with teleconferencing with an&#xD;
      psychotherapist, children and their parents. The psychotherapy is supported by an App and a&#xD;
      wristband to obtain psychophysiological data.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)</measure>
    <time_frame>beginning of the study and end therapy (about 16 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)</measure>
    <time_frame>beginning of the study and end therapy (about 16 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's Global Assessment Scale (CGAS)</measure>
    <time_frame>beginning of the study and end therapy (about 16 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Child Behavior Checklist (CBCL)</measure>
    <time_frame>beginning of the study and end therapy (about 16 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)</measure>
    <time_frame>beginning of the study and end therapy (about 16 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Impairment by OCD symptoms</measure>
    <time_frame>Every day throughout the therapy process (14 weeks)</time_frame>
    <description>assessed by App</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Extend of avoidance behavior</measure>
    <time_frame>Every day throughout the therapy process (14 weeks)</time_frame>
    <description>assessed by App</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily mood</measure>
    <time_frame>Every day throughout the therapy process (14 weeks)</time_frame>
    <description>assessed by App</description>
  </primary_outcome>
  <primary_outcome>
    <measure>How the day was</measure>
    <time_frame>Every day throughout the therapy process (14 weeks)</time_frame>
    <description>assessed by App</description>
  </primary_outcome>
  <primary_outcome>
    <measure>How strong OCD is</measure>
    <time_frame>Every week throughout the therapy process (14 weeks)</time_frame>
    <description>assessed by App</description>
  </primary_outcome>
  <primary_outcome>
    <measure>How Every week throughout the therapy processgood e progress was with specific treatment goals</measure>
    <time_frame>Every week throughout the therapy process (14 weeks)</time_frame>
    <description>assessed by App</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety ratings during exposures</measure>
    <time_frame>Every week three days beginning with session 4 up to 14</time_frame>
    <description>assessed by App</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Every day throughout the therapy (14 weeks)</time_frame>
    <description>assessed with wristband</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin conductance level</measure>
    <time_frame>Every day throughout the therapy (14 weeks)</time_frame>
    <description>assessed with wristband</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body temperature</measure>
    <time_frame>Every day throughout the therapy (14 weeks)</time_frame>
    <description>assessed with wristband</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body movements</measure>
    <time_frame>Every day throughout the therapy (14 weeks)</time_frame>
    <description>assessed with wristband</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Psychotherapy Intervention Evaluation</condition>
  <arm_group>
    <arm_group_label>Internet-based psychotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-bahavioral psychotherapy</intervention_name>
    <arm_group_label>Internet-based psychotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children and adolescents (ages 7-17) with a primary DSM-5 obsessive-compulsive&#xD;
             disorder and at least 1 primary caretaker&#xD;
&#xD;
          -  German-speaking (child &amp; caretakers)&#xD;
&#xD;
          -  Family home equipped with broadband connection and appropriate computer, monitor, HD&#xD;
             webcam, and speaker and smart phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IQ below 70&#xD;
&#xD;
          -  A psychiatric comorbidity that makes participation clinically inappropriate (for&#xD;
             example, primary anorexia nervosa), depression with suicidality that requires acute&#xD;
             treatment, and psychosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annette Conzelmann, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Child and Adolescent Psychiatry University of Tübingen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Annette Conzelmann, PhD</last_name>
    <phone>004970712987513</phone>
    <email>annette.conzelmann@med.uni-tuebingen.de</email>
  </overall_contact>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>November 25, 2016</last_update_submitted>
  <last_update_submitted_qc>November 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Tuebingen</investigator_affiliation>
    <investigator_full_name>PD Dr. Annette Conzelmann</investigator_full_name>
    <investigator_title>PD Dr. Annette Conzelmann</investigator_title>
  </responsible_party>
  <keyword>cognitive-behavioral psychotherapy</keyword>
  <keyword>obsessive-compulsive disorder</keyword>
  <keyword>internet-based</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>September 13, 2021</submitted>
    <returned>October 8, 2021</returned>
    <submitted>November 20, 2021</submitted>
    <submission_canceled>November 22, 2021</submission_canceled>
    <submitted>November 24, 2021</submitted>
    <returned>January 27, 2022</returned>
    <submitted>January 28, 2022</submitted>
    <returned>April 4, 2022</returned>
    <submitted>May 23, 2022</submitted>
    <returned>February 23, 2023</returned>
  </pending_results>
  <!-- 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/NCT02973932
org study id: F.1331477
nct id: NCT02973932
lead sponsor: 
Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms
      and an age of 7 to 17 years. Sessions are verified with teleconferencing with an
      psychotherapist, children and their parents. The psychotherapy is supported by an App and a
      wristband to obtain psychophysiological data.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)
time frame: beginning of the study and end therapy (about 16 weeks)
measure: The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
time frame: beginning of the study and end therapy (about 16 weeks)
measure: Children's Global Assessment Scale (CGAS)
time frame: beginning of the study and end therapy (about 16 weeks)
measure: Child Behavior Checklist (CBCL)
time frame: beginning of the study and end therapy (about 16 weeks)
measure: Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)
time frame: beginning of the study and end therapy (about 16 weeks)
measure: Impairment by OCD symptoms
time frame: Every day throughout the therapy process (14 weeks)
description: assessed by App
measure: Extend of avoidance behavior
time frame: Every day throughout the therapy process (14 weeks)
description: assessed by App
measure: Daily mood
time frame: Every day throughout the therapy process (14 weeks)
description: assessed by App
measure: How the day was
time frame: Every day throughout the therapy process (14 weeks)
description: assessed by App
measure: How strong OCD is
time frame: Every week throughout the therapy process (14 weeks)
description: assessed by App
measure: How Every week throughout the therapy processgood e progress was with specific treatment goals
time frame: Every week throughout the therapy process (14 weeks)
description: assessed by App
measure: Anxiety ratings during exposures
time frame: Every week three days beginning with session 4 up to 14
description: assessed by App
measure: Heart rate variability
time frame: Every day throughout the therapy (14 weeks)
description: assessed with wristband
measure: Skin conductance level
time frame: Every day throughout the therapy (14 weeks)
description: assessed with wristband
measure: Body temperature
time frame: Every day throughout the therapy (14 weeks)
description: assessed with wristband
measure: Body movements
time frame: Every day throughout the therapy (14 weeks)
description: assessed with wristband
arm group label: Internet-based psychotherapy
arm group type: Experimental
intervention type: Behavioral
intervention name: Cognitive-bahavioral psychotherapy
arm group label: Internet-based psychotherapy
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Annette Conzelmann, PhD
role: Principal Investigator
affiliation: Department of Child and Adolescent Psychiatry University of Tübingen
last name: Annette Conzelmann, PhD
phone: 004970712987513
email: annette.conzelmann@med.uni-tuebingen.de
responsible party type: Principal Investigator
investigator affiliation: University Hospital Tuebingen
investigator full name: PD Dr. Annette Conzelmann
investigator title: PD Dr. Annette Conzelmann
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
submitted: September 13, 2021
returned: October 8, 2021
submitted: November 20, 2021
submission canceled: November 22, 2021
submitted: November 24, 2021
returned: January 27, 2022
submitted: January 28, 2022
returned: April 4, 2022
submitted: May 23, 2022
returned: February 23, 2023