<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/NCT04486742</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 2019-2560</org_study_id>
    <nct_id>NCT04486742</nct_id>
  </id_info>
  <brief_title>Brief Cognitive Behavioral Therapy to Treat Itch Rumination &quot;Itch CBT&quot; in Eczema</brief_title>
  <official_title>Brief Cognitive Behavioral Therapy to Treat Itch Rumination &quot;Itch CBT&quot; in Eczema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</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>
      The main purpose of this study is to adapt cognitive behavior therapy (CBT) to improve itch&#xD;
      in children with eczema.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eczema is characterized by chronic itch. Many children develop a chronic focus (rumination)&#xD;
      on their itch. Rumination is a maladaptive method of responding to distress, in which the&#xD;
      individual thinks obsessively about the source of distress. The rumination on chronic itch in&#xD;
      eczema can have detrimental effects on one's quality of life, as well as induce significant&#xD;
      anxiety about when itch will return, how long it will last, and how it will affect physical&#xD;
      and social functioning.&#xD;
&#xD;
      Cognitive behavior therapy (CBT) is a frontline treatment for rumination, as it focuses on&#xD;
      teaching strategies so that the individual can examine distressing thoughts objectively and&#xD;
      determine their validity, replace negative thinking patterns with more adaptive thought&#xD;
      patterns, and increase the individual's awareness to their problematic thought patterns.&#xD;
      Additionally, CBT helps the individual to implement behavioral strategies to cope with&#xD;
      possibly anxiety-inducing situations, such as scratching while trying to go to sleep.&#xD;
&#xD;
      The investigators hypothesize that an Itch CBT intervention is an effective,&#xD;
      non-medication-based, easy to implement strategy to improve itch in children with eczema.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Itch Severity Numerical Rating Scale</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>Numerical rating scale to assess itch severity, scale of 0-10, higher score means higher itch severity and worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's Dermatology Life Quality Index</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>Questionnaire to assess impact of eczema on quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Itch Rumination Questionnaire</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>Questionnaire to assess common fear and anxiety around itch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Anxiety and Depression</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>Questionnaire to assess anxiety and depression symptoms in pediatric populations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Pediatric Itch - Short Form 1 (2+6)</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>Questionnaire to assess level and severity of itch and common disturbances due to itch (social, emotional, physical)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Itch CBT Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the Itch CBT Arm will participate in 4 weekly telehealth sessions with a therapist to address common areas of anxiety related to atopic dermatitis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to the Usual Care Arm of the study will receive standard of care eczema educational materials that are typically provided by their health care provider after a clinic (or telehealth) visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Itch CBT</intervention_name>
    <description>Telemedicine CBT sessions with a therapist to address atopic dermatitis related concerns.</description>
    <arm_group_label>Itch CBT Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate to severe atopic dermatitis [assessed by Patient Oriented Eczema Measure&#xD;
             (POEM)score of &gt;-8 OR NRS itch score of &gt;= 4].&#xD;
&#xD;
          -  English speaking.&#xD;
&#xD;
          -  Currently receiving treatment at Lurie Children's Hospital for atopic dermatitis.&#xD;
&#xD;
          -  Parent or guardian available to participate in protocol.&#xD;
&#xD;
          -  Have sufficient technology (e.g., cell phone, computer, tablet, etc.) that can be used&#xD;
             to access Zoom conference technology for telemedicine visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to comprehend and complete questionnaires.&#xD;
&#xD;
          -  History of intellectual disability or psychosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Paller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lurie Children's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>August 14, 2022</last_update_submitted>
  <last_update_submitted_qc>August 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Amy Paller</investigator_full_name>
    <investigator_title>Study Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT04486742/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT04486742/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04486742
org study id: IRB 2019-2560
nct id: NCT04486742
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to adapt cognitive behavior therapy (CBT) to improve itch
      in children with eczema.
Eczema is characterized by chronic itch. Many children develop a chronic focus (rumination)
      on their itch. Rumination is a maladaptive method of responding to distress, in which the
      individual thinks obsessively about the source of distress. The rumination on chronic itch in
      eczema can have detrimental effects on one's quality of life, as well as induce significant
      anxiety about when itch will return, how long it will last, and how it will affect physical
      and social functioning.

      Cognitive behavior therapy (CBT) is a frontline treatment for rumination, as it focuses on
      teaching strategies so that the individual can examine distressing thoughts objectively and
      determine their validity, replace negative thinking patterns with more adaptive thought
      patterns, and increase the individual's awareness to their problematic thought patterns.
      Additionally, CBT helps the individual to implement behavioral strategies to cope with
      possibly anxiety-inducing situations, such as scratching while trying to go to sleep.

      The investigators hypothesize that an Itch CBT intervention is an effective,
      non-medication-based, easy to implement strategy to improve itch in children with eczema.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Itch Severity Numerical Rating Scale
time frame: Baseline to Week 4
description: Numerical rating scale to assess itch severity, scale of 0-10, higher score means higher itch severity and worse outcome.
measure: Children's Dermatology Life Quality Index
time frame: Baseline to Week 4
description: Questionnaire to assess impact of eczema on quality of life.
measure: Itch Rumination Questionnaire
time frame: Baseline to Week 4
description: Questionnaire to assess common fear and anxiety around itch
measure: PROMIS Anxiety and Depression
time frame: Baseline to Week 4
description: Questionnaire to assess anxiety and depression symptoms in pediatric populations
measure: PROMIS Pediatric Itch - Short Form 1 (2+6)
time frame: Baseline to Week 4
description: Questionnaire to assess level and severity of itch and common disturbances due to itch (social, emotional, physical)
arm group label: Itch CBT Arm
arm group type: Experimental
description: Participants randomized to the Itch CBT Arm will participate in 4 weekly telehealth sessions with a therapist to address common areas of anxiety related to atopic dermatitis.
arm group label: Usual Care Arm
arm group type: No Intervention
description: Participants randomized to the Usual Care Arm of the study will receive standard of care eczema educational materials that are typically provided by their health care provider after a clinic (or telehealth) visit.
intervention type: Behavioral
intervention name: Itch CBT
description: Telemedicine CBT sessions with a therapist to address atopic dermatitis related concerns.
arm group label: Itch CBT Arm
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Amy Paller, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Amy Paller
investigator title: Study Principal Investigator
mesh term: Dermatitis
provided document: 
provided document: 