<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/NCT03247075</url>
  </required_header>
  <id_info>
    <org_study_id>DNR 2017/1027-31/2</org_study_id>
    <nct_id>NCT03247075</nct_id>
  </id_info>
  <brief_title>Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT</brief_title>
  <acronym>SOFT RCT</acronym>
  <official_title>Internet-delivered Cognitive Behavior Therapy Versus Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - A Randomized Controlled Trial</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Social anxiety disorder among youth is highly prevalent and causes significant impairment in&#xD;
      the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective&#xD;
      treatment, research suggests that many young people with this disorder do not have access to&#xD;
      good-quality CBT. Internet-delivered CBT could be an effective method to increase&#xD;
      availability of evidence-based treatments for youth with social anxiety disorder. The primary&#xD;
      objective of this study is to test the efficacy of internet-delivered CBT (ICBT) for youth&#xD;
      (10 - 17 years) with social anxiety disorder. The investigators aim to conduct a randomized&#xD;
      controlled trial with N = 101 participants. Participants will be randomized to either the&#xD;
      active treatment arm (guided ICBT) or to a control condition (guided internet-delivered&#xD;
      support and counseling). Follow-ups will be conducted at 3 and 12 months after&#xD;
      post-assessment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>Clinician Severity Rating (CSR)</measure>
    <time_frame>6 months (14 months including follow-up)</time_frame>
    <description>A 0-8 rating by a professional assessor, specifying the severity of social anxiety</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Social anxiety disorder</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>Diagnostic status: Social anxiety disorder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Comorbid disorders</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>Diagnostic status: Comorbid psychiatric disorders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Improvement (CGI-I)</measure>
    <time_frame>Measured over the course of 3 months (12 months including follow-up)</time_frame>
    <description>A 1-7 rating by a professional assessor, specifying the degree of improvement from treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Global Assessment Scale (CGAS)</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A 0-100 rating by a professional assessor, specifying global functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version</measure>
    <time_frame>6 months (14 months including follow-up)</time_frame>
    <description>A self-rated measure of severity of social anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Parent version</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A parent-rated measure of severity of social anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Children´s Anxiety and Depression Scale - (RCADS) - Parent version</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A parent-rated measure of severity of anxiety and depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Children´s Anxiety and Depression Scale - (RCADS) Depression sub scale - Child version</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A parent-rated measure of severity of anxiety and depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anticipatory social behaviors scale (ASBQ)</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A self-rated measure of anticipatory anxiety before social situations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-event processing questionnaire revised (PEPQ-R)</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A self-rated measure of anxiety and rumination experienced after social situations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Focus of attention questionnaire (FAQ)</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A self-rated measure of self-focus in social situations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Subtle Avoidance Frequency Examination (SAFE)</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A self-rated measure of safety behaviors in social situations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Child Health Utility 9D (CHU 9D) - Child version</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A self-rated measure of quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ-) - Child version</measure>
    <time_frame>Measured only at post-treatment</time_frame>
    <description>A self-rated measure of treatment satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ-) - Parent version</measure>
    <time_frame>Measured only at post-treatment</time_frame>
    <description>A parent-rated measure of treatment satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment credibility and expectancy - Child version</measure>
    <time_frame>Measured at one time-point, at week three in the allocated intervention.</time_frame>
    <description>A self-rated measure of credibility and expectancy of allocated treatment condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment credibility and expectancy - Parent version</measure>
    <time_frame>Measured at one time-point, at week three in the allocated intervention.</time_frame>
    <description>A parent-rated measure of credibility and expectancy of allocated treatment condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Education, Work and Social Adjustment Scale (EWSAS) - Parent version</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A parent-rated measure of functioning in everyday life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Measured only at pre-treatments</time_frame>
    <description>A self-rated measure of anxiety and depression among parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Disorder Identification Test (AUDIT)</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A self-rated screening measure for hazardous and harmful alcohol consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug Use Disorders Identification Test (DUDIT)</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A self-rated screening measure for drug-related problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Accommodation Scale-Anxiety (FASA)</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A parent-rated measure of parental accommodation to the child's anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) - Child version</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A parent-rated measure of direct and indirect costs related to psychiatric illness in children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Negative Effects Questionnaire (NEQ)</measure>
    <time_frame>Measured only at post-treatment</time_frame>
    <description>A self-rated measure of treatment related adverse and unwanted events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Internet intervention Patient Adherence Scale (iiPAS)</measure>
    <time_frame>Measured at mid-treatment (week 5) and at post-treatment (week 10)</time_frame>
    <description>A clinician-rated measure of adherence to the allocated treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School absenteeism</measure>
    <time_frame>Measured over the course of 6 months (14 months including follow-up)</time_frame>
    <description>A parent-rated measure of the frequency of school absenteeism</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Social Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>Internet-delivered Cognitive Behavior Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 weeks of guided Internet-delivered Cognitive Behavior Therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Internet-delivered Support and Counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 weeks of guided Internet-delivered support and counseling</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavior Therapy</intervention_name>
    <description>Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms</description>
    <arm_group_label>Internet-delivered Cognitive Behavior Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Support and Counseling</intervention_name>
    <description>Guided Internet-delivered support and counseling includes educative material about social anxiety and health related issues such as physical activity, nutritious diet, sleep habits etc.</description>
    <arm_group_label>Internet-delivered Support and Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A principal diagnosis of social anxiety disorder, as defined by DSM-5&#xD;
&#xD;
          -  Age between 10 and 17 years&#xD;
&#xD;
          -  Ability to read and write Swedish&#xD;
&#xD;
          -  Daily access to the internet through a computer or similar device&#xD;
&#xD;
          -  A parent or caregiver 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 with autism spectrum disorder, psychosis, bipolar disorder or severe eating&#xD;
             disorder&#xD;
&#xD;
          -  Present risk of suicide&#xD;
&#xD;
          -  Ongoing alcohol or substance abuse&#xD;
&#xD;
          -  Occurrence of domestic violence&#xD;
&#xD;
          -  Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5&#xD;
             sessions of CBT including in vivo exposure sessions)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Serlachius, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BUP KFE</name>
      <address>
        <city>Stockholm</city>
        <state>Stockholms County</state>
        <zip>113 30</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>January 24, 2021</last_update_submitted>
  <last_update_submitted_qc>January 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</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>Associate professor, child psychiatrist, MD</investigator_title>
  </responsible_party>
  <keyword>Social anxiety disorder</keyword>
  <keyword>Cognitive Behavior Therapy</keyword>
  <keyword>Internet-delivered treatments</keyword>
  <keyword>Children and adolescents</keyword>
  <keyword>Randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Phobia, Social</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/NCT03247075
org study id: DNR 2017/1027-31/2
nct id: NCT03247075
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Social anxiety disorder among youth is highly prevalent and causes significant impairment in
      the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective
      treatment, research suggests that many young people with this disorder do not have access to
      good-quality CBT. Internet-delivered CBT could be an effective method to increase
      availability of evidence-based treatments for youth with social anxiety disorder. The primary
      objective of this study is to test the efficacy of internet-delivered CBT (ICBT) for youth
      (10 - 17 years) with social anxiety disorder. The investigators aim to conduct a randomized
      controlled trial with N = 101 participants. Participants will be randomized to either the
      active treatment arm (guided ICBT) or to a control condition (guided internet-delivered
      support and counseling). Follow-ups will be conducted at 3 and 12 months after
      post-assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinician Severity Rating (CSR)
time frame: 6 months (14 months including follow-up)
description: A 0-8 rating by a professional assessor, specifying the severity of social anxiety
measure: Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Social anxiety disorder
time frame: Measured over the course of 6 months (14 months including follow-up)
description: Diagnostic status: Social anxiety disorder
measure: Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Comorbid disorders
time frame: Measured over the course of 6 months (14 months including follow-up)
description: Diagnostic status: Comorbid psychiatric disorders
measure: Clinical Global Impression - Improvement (CGI-I)
time frame: Measured over the course of 3 months (12 months including follow-up)
description: A 1-7 rating by a professional assessor, specifying the degree of improvement from treatment
measure: Children's Global Assessment Scale (CGAS)
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A 0-100 rating by a professional assessor, specifying global functioning
measure: Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version
time frame: 6 months (14 months including follow-up)
description: A self-rated measure of severity of social anxiety
measure: Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Parent version
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A parent-rated measure of severity of social anxiety
measure: Revised Children´s Anxiety and Depression Scale - (RCADS) - Parent version
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A parent-rated measure of severity of anxiety and depression
measure: Revised Children´s Anxiety and Depression Scale - (RCADS) Depression sub scale - Child version
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A parent-rated measure of severity of anxiety and depression
measure: Anticipatory social behaviors scale (ASBQ)
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A self-rated measure of anticipatory anxiety before social situations
measure: Post-event processing questionnaire revised (PEPQ-R)
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A self-rated measure of anxiety and rumination experienced after social situations
measure: Focus of attention questionnaire (FAQ)
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A self-rated measure of self-focus in social situations
measure: The Subtle Avoidance Frequency Examination (SAFE)
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A self-rated measure of safety behaviors in social situations
measure: The Child Health Utility 9D (CHU 9D) - Child version
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A self-rated measure of quality of life
measure: Client Satisfaction Questionnaire (CSQ-) - Child version
time frame: Measured only at post-treatment
description: A self-rated measure of treatment satisfaction
measure: Client Satisfaction Questionnaire (CSQ-) - Parent version
time frame: Measured only at post-treatment
description: A parent-rated measure of treatment satisfaction
measure: Treatment credibility and expectancy - Child version
time frame: Measured at one time-point, at week three in the allocated intervention.
description: A self-rated measure of credibility and expectancy of allocated treatment condition
measure: Treatment credibility and expectancy - Parent version
time frame: Measured at one time-point, at week three in the allocated intervention.
description: A parent-rated measure of credibility and expectancy of allocated treatment condition
measure: Education, Work and Social Adjustment Scale (EWSAS) - Parent version
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A parent-rated measure of functioning in everyday life
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: Measured only at pre-treatments
description: A self-rated measure of anxiety and depression among parents
measure: Alcohol Disorder Identification Test (AUDIT)
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A self-rated screening measure for hazardous and harmful alcohol consumption
measure: Drug Use Disorders Identification Test (DUDIT)
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A self-rated screening measure for drug-related problems
measure: Family Accommodation Scale-Anxiety (FASA)
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A parent-rated measure of parental accommodation to the child's anxiety
measure: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) - Child version
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A parent-rated measure of direct and indirect costs related to psychiatric illness in children
measure: The Negative Effects Questionnaire (NEQ)
time frame: Measured only at post-treatment
description: A self-rated measure of treatment related adverse and unwanted events
measure: Internet intervention Patient Adherence Scale (iiPAS)
time frame: Measured at mid-treatment (week 5) and at post-treatment (week 10)
description: A clinician-rated measure of adherence to the allocated treatment
measure: School absenteeism
time frame: Measured over the course of 6 months (14 months including follow-up)
description: A parent-rated measure of the frequency of school absenteeism
arm group label: Internet-delivered Cognitive Behavior Therapy
arm group type: Experimental
description: 10 weeks of guided Internet-delivered Cognitive Behavior Therapy
arm group label: Internet-delivered Support and Counseling
arm group type: Active Comparator
description: 10 weeks of guided Internet-delivered support and counseling
intervention type: Behavioral
intervention name: Cognitive Behavior Therapy
description: Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms
arm group label: Internet-delivered Cognitive Behavior Therapy
intervention type: Behavioral
intervention name: Support and Counseling
description: Guided Internet-delivered support and counseling includes educative material about social anxiety and health related issues such as physical activity, nutritious diet, sleep habits etc.
arm group label: Internet-delivered Support and Counseling
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: Eva Serlachius, PhD, MD
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: Associate professor, child psychiatrist, MD
mesh term: Anxiety Disorders
mesh term: Phobia, Social
sharing ipd: No