<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/NCT03263546</url>
  </required_header>
  <id_info>
    <org_study_id>REPN 2017/1070-31/1</org_study_id>
    <nct_id>NCT03263546</nct_id>
  </id_info>
  <brief_title>Internet-delivered CBT for Paediatric OCD</brief_title>
  <official_title>Implementation of Internet-delivered Cognitive-behavior Therapy for Paediatric Obsessive-compulsive Disorder in the Clinic: a Randomized Stepped Care Non-inferiority Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Stockholm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate if therapist-guided internet-delivered cognitive&#xD;
      behavioral therapy (ICBT) in a stepped-care approach is an effective and cost-effective&#xD;
      treatment in reducing OCD symptoms for children and adolescents compared to gold standard&#xD;
      treatment (face-to-face CBT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled non-inferiority trial comparing therapist-guided internet-delivered&#xD;
      cognitive behavioral therapy (ICBT) in a stepped care model with face-to-face CBT for&#xD;
      children and adolescents with obsessive-compulsive disorder (OCD).&#xD;
&#xD;
      Participants will be randomized to either stepped care ICBT or to gold standard face-to-face&#xD;
      CBT. One group (stepped care) will be first offered ICBT for 16 weeks. Non-responders at the&#xD;
      3-month follow-up will receive additional face-to-face CBT. The other group (gold standard&#xD;
      treatment) will be randomized directly to receive face-to-face CBT for 16 weeks.&#xD;
      Non-responders will, as in the other group, receive additional face-to-face treatment after&#xD;
      the 3-month follow-up. The primary endpoint will be at 6-month follow-up. Long-term effects&#xD;
      are also investigated (1 year, 2 years and 5 years after treatment completion).&#xD;
&#xD;
      The primary objective is to evaluate whether ICBT in a stepped care approach will be&#xD;
      non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms,&#xD;
      depression, impairment, sleep problems, health and functioning. The secondary objective is to&#xD;
      a) carry out a full health economic evaluation and b) investigate if self-referred and&#xD;
      referred participants differ regarding outcome in the two treatment groups.&#xD;
&#xD;
      The hypotheses are:&#xD;
&#xD;
        1. An ICBT stepped care approach will be non-inferior to gold standard treatment&#xD;
           (face-to-face CBT) in reducing OCD symptoms.&#xD;
&#xD;
        2. The stepped care approach will be associated with lower costs, such as reduced therapist&#xD;
           and administration times, service utilization, minimized work and school absence for&#xD;
           families etc., compared to gold standard treatment.&#xD;
&#xD;
        3. Self-referred patients will benefit significantly better than referred patients&#xD;
           regarding outcome in the ICBT group, but there will not be any difference in the&#xD;
           face-to-face CBT group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 6, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">April 28, 2020</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>week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.</time_frame>
    <description>Change in OCD symptom severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. Primary endpoint is 6 months follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical global impression severity (CGI-S)</measure>
    <time_frame>week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up</time_frame>
    <description>Change in global severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical global impression improvement (CGI-I)</measure>
    <time_frame>week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up</time_frame>
    <description>Change in global improvement from week 16 to 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's global assessment scale (C-GAS)</measure>
    <time_frame>week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up</time_frame>
    <description>Change in global functioning from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obsessive-compulsive inventory - child version (OCI-CV)</measure>
    <time_frame>week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment</time_frame>
    <description>Change in child-rated OCD symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, at 1 year follow-up, and weekly during treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Child Health Utility 9D (CHU9D)</measure>
    <time_frame>week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up</time_frame>
    <description>Change in general health from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up</time_frame>
    <description>Change in sleep problems from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Obsessional Compulsive Inventory Revised - parent version (ChOCI-R)</measure>
    <time_frame>week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment</time_frame>
    <description>Change in parent-rated OCD symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, at 1 year follow-up, and weekly during treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family accommodation scale for obsessive-compulsive disorder - self-rated version (FAS-SR)</measure>
    <time_frame>week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up</time_frame>
    <description>Change in parent-rated family accommodation from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P)</measure>
    <time_frame>week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.</time_frame>
    <description>Change in economic costs from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood and Feeling Questionnaire (MFQ)</measure>
    <time_frame>week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up</time_frame>
    <description>Change in child and parent rated depressive symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Education, work and social adjustment scale (EWSAS)</measure>
    <time_frame>week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up</time_frame>
    <description>Change in child and parent rated impairment and functioning from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Autism Spectrum Quotient (AQ-10)</measure>
    <time_frame>week 0</time_frame>
    <description>Measure of autistic symptoms at baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment credibility and expectancy scale</measure>
    <time_frame>week 2</time_frame>
    <description>Child and parent version. Investigate if both conditions have equal credibility in order to rule out placebo.</description>
  </other_outcome>
  <other_outcome>
    <measure>Working alliance inventory (WAI)</measure>
    <time_frame>week 2</time_frame>
    <description>Child and parent version. Investigate if both conditions have equal working alliance in order to rule out non-specific factors.</description>
  </other_outcome>
  <other_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ-8)</measure>
    <time_frame>week 16 and at 6 months follow-up</time_frame>
    <description>Child and parent version. Investigate if both conditions have equal satisfaction.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient EX/RP Adherence Scale (PEAS)</measure>
    <time_frame>week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16</time_frame>
    <description>Clinician-rated version during face-to-face CBT. Self-rated version during both ICBT and face-to-face CBT. Investigate treatment adherence in both conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>internet intervention Patient Adherence Scale (iiPAS)</measure>
    <time_frame>week 8 and 16</time_frame>
    <description>Investigate treatment adherence in the ICBT condition.</description>
  </other_outcome>
  <other_outcome>
    <measure>Parental strategy scale</measure>
    <time_frame>week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16</time_frame>
    <description>Investigate the use of parental strategies weekly during treatment.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">152</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Stepped care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Internet-delivered cognitive behavioral therapy (ICBT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gold standard treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cognitive behavioral therapy (CBT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet-delivered cognitive behavioral therapy (ICBT)</intervention_name>
    <description>Participants will receive internet-delivered CBT with therapist support for 16 weeks. The treatment consists of 14 online chapters with interactive features as videos and illustrations. The treatment has the main focus on exposure with ritual prevention. The children and parents have regular contact with a personal assigned therapist via written text messages in the platform.&#xD;
Participants that are classified as non-responders at 3 months follow-up will receive face-to-face CBT of up to 12 sessions over 12 weeks.</description>
    <arm_group_label>Stepped care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral therapy (CBT)</intervention_name>
    <description>Participants in the gold standard group will receive 14 individual face-to-face CBT sessions over 16 weeks. The treatment is based on current evidence based recommendations for OCD, and focuses on exposure with ritual prevention.&#xD;
Participants that are classified as non-responders at 3 months follow-up will receive additional face-to-face CBT of up to 12 sessions over 12 weeks.</description>
    <arm_group_label>Gold standard treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary DSM-5 diagnosis of OCD&#xD;
&#xD;
          -  Total score of ≥16 on the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)&#xD;
&#xD;
          -  Age between 7 and 17 years&#xD;
&#xD;
          -  Ability to read and write Swedish and with access to a computer and use of internet.&#xD;
&#xD;
          -  Participants on psychotropic medication must had been on a stable dose for the last 6&#xD;
             weeks prior to baseline assessment. If the child is on medication for OCD, they will&#xD;
             be requested to stay on stable doses for the duration of the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Organic brain disorders, global learning disabilities, autism spectrum disorder,&#xD;
             psychosis, bipolar disorder and severe eating disorder.&#xD;
&#xD;
          -  Suicidal ideation&#xD;
&#xD;
          -  Not able to understand the basics of the ICBT self-help material, patient being&#xD;
             housebound or in need of intensive- or in-patient treatment.&#xD;
&#xD;
          -  Having completed a course of CBT for OCD within the last 12 months (defined as at&#xD;
             least 5 sessions CBT including exposure and response prevention).&#xD;
&#xD;
          -  Children with ongoing psychological treatment for OCD or another anxiety disorder will&#xD;
             not be included in the study.&#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>Eva Serlachius, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BUP Specialmottagning</name>
      <address>
        <city>Göteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Child and Adolescent Psychiatry (CAP) research center</name>
      <address>
        <city>Stockholm</city>
        <zip>11330</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</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, associate professor</investigator_title>
  </responsible_party>
  <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>No</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/NCT03263546
org study id: REPN 2017/1070-31/1
nct id: NCT03263546
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate if therapist-guided internet-delivered cognitive
      behavioral therapy (ICBT) in a stepped-care approach is an effective and cost-effective
      treatment in reducing OCD symptoms for children and adolescents compared to gold standard
      treatment (face-to-face CBT).
A randomized controlled non-inferiority trial comparing therapist-guided internet-delivered
      cognitive behavioral therapy (ICBT) in a stepped care model with face-to-face CBT for
      children and adolescents with obsessive-compulsive disorder (OCD).

      Participants will be randomized to either stepped care ICBT or to gold standard face-to-face
      CBT. One group (stepped care) will be first offered ICBT for 16 weeks. Non-responders at the
      3-month follow-up will receive additional face-to-face CBT. The other group (gold standard
      treatment) will be randomized directly to receive face-to-face CBT for 16 weeks.
      Non-responders will, as in the other group, receive additional face-to-face treatment after
      the 3-month follow-up. The primary endpoint will be at 6-month follow-up. Long-term effects
      are also investigated (1 year, 2 years and 5 years after treatment completion).

      The primary objective is to evaluate whether ICBT in a stepped care approach will be
      non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms,
      depression, impairment, sleep problems, health and functioning. The secondary objective is to
      a) carry out a full health economic evaluation and b) investigate if self-referred and
      referred participants differ regarding outcome in the two treatment groups.

      The hypotheses are:

        1. An ICBT stepped care approach will be non-inferior to gold standard treatment
           (face-to-face CBT) in reducing OCD symptoms.

        2. The stepped care approach will be associated with lower costs, such as reduced therapist
           and administration times, service utilization, minimized work and school absence for
           families etc., compared to gold standard treatment.

        3. Self-referred patients will benefit significantly better than referred patients
           regarding outcome in the ICBT group, but there will not be any difference in the
           face-to-face CBT group.
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: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.
description: Change in OCD symptom severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. Primary endpoint is 6 months follow-up.
measure: Clinical global impression severity (CGI-S)
time frame: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up
description: Change in global severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up.
measure: Clinical global impression improvement (CGI-I)
time frame: week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up
description: Change in global improvement from week 16 to 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up.
measure: Children's global assessment scale (C-GAS)
time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
description: Change in global functioning from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up.
measure: Obsessive-compulsive inventory - child version (OCI-CV)
time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment
description: Change in child-rated OCD symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, at 1 year follow-up, and weekly during treatment.
measure: The Child Health Utility 9D (CHU9D)
time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
description: Change in general health from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up.
measure: Insomnia Severity Index (ISI)
time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
description: Change in sleep problems from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up
measure: Children's Obsessional Compulsive Inventory Revised - parent version (ChOCI-R)
time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment
description: Change in parent-rated OCD symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, at 1 year follow-up, and weekly during treatment.
measure: Family accommodation scale for obsessive-compulsive disorder - self-rated version (FAS-SR)
time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
description: Change in parent-rated family accommodation from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up
measure: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P)
time frame: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.
description: Change in economic costs from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up.
measure: Mood and Feeling Questionnaire (MFQ)
time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
description: Change in child and parent rated depressive symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up
measure: Education, work and social adjustment scale (EWSAS)
time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
description: Change in child and parent rated impairment and functioning from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up
measure: Autism Spectrum Quotient (AQ-10)
time frame: week 0
description: Measure of autistic symptoms at baseline
measure: Treatment credibility and expectancy scale
time frame: week 2
description: Child and parent version. Investigate if both conditions have equal credibility in order to rule out placebo.
measure: Working alliance inventory (WAI)
time frame: week 2
description: Child and parent version. Investigate if both conditions have equal working alliance in order to rule out non-specific factors.
measure: Client Satisfaction Questionnaire (CSQ-8)
time frame: week 16 and at 6 months follow-up
description: Child and parent version. Investigate if both conditions have equal satisfaction.
measure: Patient EX/RP Adherence Scale (PEAS)
time frame: week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16
description: Clinician-rated version during face-to-face CBT. Self-rated version during both ICBT and face-to-face CBT. Investigate treatment adherence in both conditions.
measure: internet intervention Patient Adherence Scale (iiPAS)
time frame: week 8 and 16
description: Investigate treatment adherence in the ICBT condition.
measure: Parental strategy scale
time frame: week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16
description: Investigate the use of parental strategies weekly during treatment.
arm group label: Stepped care
arm group type: Experimental
description: Internet-delivered cognitive behavioral therapy (ICBT)
arm group label: Gold standard treatment
arm group type: Active Comparator
description: Cognitive behavioral therapy (CBT)
intervention type: Behavioral
intervention name: Internet-delivered cognitive behavioral therapy (ICBT)
description: Participants will receive internet-delivered CBT with therapist support for 16 weeks. The treatment consists of 14 online chapters with interactive features as videos and illustrations. The treatment has the main focus on exposure with ritual prevention. The children and parents have regular contact with a personal assigned therapist via written text messages in the platform.
Participants that are classified as non-responders at 3 months follow-up will receive face-to-face CBT of up to 12 sessions over 12 weeks.
arm group label: Stepped care
intervention type: Behavioral
intervention name: Cognitive behavioral therapy (CBT)
description: Participants in the gold standard group will receive 14 individual face-to-face CBT sessions over 16 weeks. The treatment is based on current evidence based recommendations for OCD, and focuses on exposure with ritual prevention.
Participants that are classified as non-responders at 3 months follow-up will receive additional face-to-face CBT of up to 12 sessions over 12 weeks.
arm group label: Gold standard treatment
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Eva Serlachius, MD, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Eva Serlachius
investigator title: MD, associate professor
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
sharing ipd: No