<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/NCT02978963</url>
  </required_header>
  <id_info>
    <org_study_id>EPN DNR 2016/1408-31/5</org_study_id>
    <nct_id>NCT02978963</nct_id>
  </id_info>
  <brief_title>CBT for Adolescents With Excessive Worry</brief_title>
  <acronym>BiPOro</acronym>
  <official_title>Cognitive Behavioral Therapy for Adolescents With Excessive Worry - a Case Series</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>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This case series aims to test the feasibility and acceptability of streamlined cognitive&#xD;
      behavioral therapy (CBT) for adolescents with excessive worry. The treatment protocol focuses&#xD;
      on reducing intolerance of uncertainty and the hypothesis is that this will help reduce&#xD;
      worry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study aims to test a new form of Cognitive Behavioral Therapy for adolescents with&#xD;
      excessive worry. The investigators will include 12 participants with excessive worry and test&#xD;
      the treatment which focuses on reducing intolerance of uncertainty (IU) in order to reduce&#xD;
      worry.&#xD;
&#xD;
      Participants will be randomized to either one, two or three weeks of weekly baseline&#xD;
      measurements prior to starting treatment, and will thus work as their on controls in this&#xD;
      case series design.&#xD;
&#xD;
      Primary outcome measures will be collected at 12 weeks after treatment start. Participants&#xD;
      will be followed up at three months after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Penn State Worry Questionnaire for Children (PSWQ-C)</measure>
    <time_frame>At 12 weeks after treatment starts</time_frame>
    <description>Child and parent version</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)</measure>
    <time_frame>Baseline, 12 weeks after start of treatment and three month after treatment has ended.</time_frame>
    <description>Diagnostic interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Severity (CGI-S)</measure>
    <time_frame>Baseline, 12 weeks after start of treatment and three month after treatment has ended.</time_frame>
    <description>Clinician rated severity of symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Improvement (CGI-I)</measure>
    <time_frame>At 12 weeks after start of treatment and three month after treatment has ended.</time_frame>
    <description>Clinician rated improvement after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Global Assessment Scale (CGAS)</measure>
    <time_frame>Baseline, 12 weeks after start of treatment and three month after treatment has ended.</time_frame>
    <description>Clinician rated global functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Intolerance of Uncertainty Scale (Brief IUS)</measure>
    <time_frame>Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended</time_frame>
    <description>Self rated tolerance to treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Cognitive Avoidance Questionnaire (Brief CAQ)</measure>
    <time_frame>Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended</time_frame>
    <description>Self rated cognitive avoidance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Why Worry-II (Brief WW2)</measure>
    <time_frame>Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended</time_frame>
    <description>Self rated positive assumptions of worry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Problem Orientation Questionnaire (NPOQ)</measure>
    <time_frame>Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended</time_frame>
    <description>Self rated negative problem orientation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Children´s Anxiety and Depression Scale (RCADS-C)</measure>
    <time_frame>Baseline, 12 weeks after start of treatment and three month after treatment has ended.</time_frame>
    <description>Child and parent version.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Education, Work and Social Adjustment Scale (EWSAS)</measure>
    <time_frame>Baseline, 12 weeks after start of treatment and three month after treatment has ended.</time_frame>
    <description>Child and parent version.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Excessive Worry</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive cognitive behavioral therapy for excessive worry. Focus in treatment will be on reducing participants' intolerance uncertainty through in vivo and imaginary exposure to uncertainty inducing situations and thoughts. Treatment will also contain psycho education about anxiety and worry, as well as planning for maintenance of treatment gains. Parents of the participants will receive support and education about worry through an internet-delivered program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral therapy</intervention_name>
    <description>CBT focused on reducing intolerance of uncertainty</description>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    <other_name>CBT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A score on PSWQ-C of at least 22&#xD;
&#xD;
          -  Age between 13 and 17 years&#xD;
&#xD;
          -  Ability to read and write in Swedish&#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;
          -  Diagnosis of autism spectrum disorder, psychosis, bipolar disorder or severe eating&#xD;
             disorder&#xD;
&#xD;
          -  Present risk of suicide&#xD;
&#xD;
          -  Ongoing substance dependence&#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>13 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 2017</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>December 20, 2017</last_update_submitted>
  <last_update_submitted_qc>December 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2017</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</investigator_title>
  </responsible_party>
  <keyword>Excessive worry</keyword>
  <keyword>Worry</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Intolerance of uncertainty</keyword>
  <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/NCT02978963
org study id: EPN DNR 2016/1408-31/5
nct id: NCT02978963
lead sponsor: 
collaborator: 
has dmc: No
This case series aims to test the feasibility and acceptability of streamlined cognitive
      behavioral therapy (CBT) for adolescents with excessive worry. The treatment protocol focuses
      on reducing intolerance of uncertainty and the hypothesis is that this will help reduce
      worry.
This pilot study aims to test a new form of Cognitive Behavioral Therapy for adolescents with
      excessive worry. The investigators will include 12 participants with excessive worry and test
      the treatment which focuses on reducing intolerance of uncertainty (IU) in order to reduce
      worry.

      Participants will be randomized to either one, two or three weeks of weekly baseline
      measurements prior to starting treatment, and will thus work as their on controls in this
      case series design.

      Primary outcome measures will be collected at 12 weeks after treatment start. Participants
      will be followed up at three months after treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Penn State Worry Questionnaire for Children (PSWQ-C)
time frame: At 12 weeks after treatment starts
description: Child and parent version
measure: Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
description: Diagnostic interview
measure: Clinical Global Impression - Severity (CGI-S)
time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
description: Clinician rated severity of symptoms
measure: Clinical Global Impression - Improvement (CGI-I)
time frame: At 12 weeks after start of treatment and three month after treatment has ended.
description: Clinician rated improvement after treatment
measure: Children's Global Assessment Scale (CGAS)
time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
description: Clinician rated global functioning
measure: Brief Intolerance of Uncertainty Scale (Brief IUS)
time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
description: Self rated tolerance to treatment
measure: Brief Cognitive Avoidance Questionnaire (Brief CAQ)
time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
description: Self rated cognitive avoidance
measure: Brief Why Worry-II (Brief WW2)
time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
description: Self rated positive assumptions of worry
measure: Negative Problem Orientation Questionnaire (NPOQ)
time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
description: Self rated negative problem orientation
measure: Revised Children´s Anxiety and Depression Scale (RCADS-C)
time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
description: Child and parent version.
measure: Education, Work and Social Adjustment Scale (EWSAS)
time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
description: Child and parent version.
arm group label: Cognitive Behavioral Therapy
arm group type: Experimental
description: All participants will receive cognitive behavioral therapy for excessive worry. Focus in treatment will be on reducing participants' intolerance uncertainty through in vivo and imaginary exposure to uncertainty inducing situations and thoughts. Treatment will also contain psycho education about anxiety and worry, as well as planning for maintenance of treatment gains. Parents of the participants will receive support and education about worry through an internet-delivered program.
intervention type: Behavioral
intervention name: Cognitive behavioral therapy
description: CBT focused on reducing intolerance of uncertainty
arm group label: Cognitive Behavioral Therapy
other name: CBT
criteria: 
gender: All
minimum age: 13 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: Associate professor
sharing ipd: No