<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/NCT02191631</url>
  </required_header>
  <id_info>
    <org_study_id>BiPOCD RCT</org_study_id>
    <nct_id>NCT02191631</nct_id>
  </id_info>
  <brief_title>Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study</brief_title>
  <acronym>BiPOCD</acronym>
  <official_title>Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17&#xD;
      years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either&#xD;
      ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment&#xD;
      condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to test the efficacy of Internet-delivered cognitive&#xD;
      behavior therapy (ICBT) for adolescents (12 - 17 years) with OCD. We aim to conduct a&#xD;
      randomized controlled study with N = 66 participants. Participants will be randomly assigned&#xD;
      to ICBT or a wait list condition, either lasting 12 weeks. The primary outcome measure is the&#xD;
      Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be&#xD;
      followed up 3 and 12 months after treatment. ICBT is expected to yield significantly better&#xD;
      symptom reduction than the wait list condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS</measure>
    <time_frame>Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended</time_frame>
    <description>Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 12 months after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Severity, CGI-S</measure>
    <time_frame>Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Improvement, CGI-I</measure>
    <time_frame>Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent Adherence EX/RP Scale, PEAS</measure>
    <time_frame>Baseline, 6 and 12 weeks after treatment starts</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003)</measure>
    <time_frame>Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Education, Work and Social Adjustment Scale - child and parent version (EWSAS)</measure>
    <time_frame>Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spence Child Anxiety Scale - Child and Parent version (SCAS-C/P, Spence, 1998</measure>
    <time_frame>Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Depression Inventory - Short version (CDI-S, Kovacs, 1985)</measure>
    <time_frame>Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009)</measure>
    <time_frame>Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technology acceptance scale</measure>
    <time_frame>Baseline, 6 and 12 weeks after treatment starts,</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)</measure>
    <time_frame>Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D - quality of life</measure>
    <time_frame>Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Measurement of homework adherence</measure>
    <time_frame>Baseline, daily measurements until 12 weeks after baseline</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>12 weeks after baseline</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>DNA samples (from blood and/or saliva)</measure>
    <time_frame>Baseline</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Internet-delivered CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 12 weeks of internet-delivered cognitive behavior therapy with psychologist support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive no treatment for 12 weeks. After that period participants will receive Internet-delivered Cognitive Behavior Therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet-delivered Cognitive Behavior Therapy</intervention_name>
    <description>The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet plattform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks.</description>
    <arm_group_label>Internet-delivered CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a primary diagnosis of OCD as defined by DSM-5&#xD;
&#xD;
          -  a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS&#xD;
&#xD;
          -  age between 12 and 17 years&#xD;
&#xD;
          -  ability to read and write Swedish&#xD;
&#xD;
          -  daily access to the internet&#xD;
&#xD;
          -  a parent that is able to co-participate in the treatment&#xD;
&#xD;
          -  Participants on psychotropic medication must have been on a stable dose for the last 6&#xD;
             weeks prior to baseline assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosed autism spectrum disorder, psychosis or bipolar disorder, severe eating&#xD;
             disorder&#xD;
&#xD;
          -  suicidal ideation&#xD;
&#xD;
          -  ongoing substance dependence&#xD;
&#xD;
          -  subject not able to read or understand the basics of the ICBT material&#xD;
&#xD;
          -  completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT&#xD;
             including exposure and response prevention)&#xD;
&#xD;
          -  ongoing psychological treatment for OCD or another anxiety disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Serlachius, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska Institutet</name>
      <address>
        <city>Stockholm</city>
        <zip>171 77</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Eva Serlachius</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>OCD</keyword>
  <keyword>adolescents</keyword>
  <keyword>pediatric</keyword>
  <keyword>internet</keyword>
  <keyword>online</keyword>
  <keyword>CBT</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>
  <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/NCT02191631
org study id: BiPOCD RCT
nct id: NCT02191631
lead sponsor: 
has dmc: No
The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17
      years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either
      ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment
      condition.
The primary objective of this study is to test the efficacy of Internet-delivered cognitive
      behavior therapy (ICBT) for adolescents (12 - 17 years) with OCD. We aim to conduct a
      randomized controlled study with N = 66 participants. Participants will be randomly assigned
      to ICBT or a wait list condition, either lasting 12 weeks. The primary outcome measure is the
      Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be
      followed up 3 and 12 months after treatment. ICBT is expected to yield significantly better
      symptom reduction than the wait list condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
description: Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 12 months after treatment
measure: Clinical Global Impression - Severity, CGI-S
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Clinical Global Impression - Improvement, CGI-I
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Parent Adherence EX/RP Scale, PEAS
time frame: Baseline, 6 and 12 weeks after treatment starts
measure: Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003)
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Education, Work and Social Adjustment Scale - child and parent version (EWSAS)
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Spence Child Anxiety Scale - Child and Parent version (SCAS-C/P, Spence, 1998
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Child Depression Inventory - Short version (CDI-S, Kovacs, 1985)
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009)
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Technology acceptance scale
time frame: Baseline, 6 and 12 weeks after treatment starts,
measure: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: EQ-5D - quality of life
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Measurement of homework adherence
time frame: Baseline, daily measurements until 12 weeks after baseline
measure: Number of Participants with Adverse Events
time frame: 12 weeks after baseline
measure: DNA samples (from blood and/or saliva)
time frame: Baseline
arm group label: Internet-delivered CBT
arm group type: Experimental
description: Participants will receive 12 weeks of internet-delivered cognitive behavior therapy with psychologist support.
arm group label: Wait list
arm group type: No Intervention
description: Participants will receive no treatment for 12 weeks. After that period participants will receive Internet-delivered Cognitive Behavior Therapy.
intervention type: Behavioral
intervention name: Internet-delivered Cognitive Behavior Therapy
description: The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet plattform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks.
arm group label: Internet-delivered CBT
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Eva Serlachius, MD, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Eva Serlachius
investigator title: MD, PhD
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
sharing ipd: Undecided