xml: <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/NCT06024395</url>
    </required_header>
    <id_info>
      <org_study_id>23-042-E</org_study_id>
      <nct_id>NCT06024395</nct_id>
    </id_info>
    <brief_title>A Stepped Care Approach to Treating Dental Fear</brief_title>
    <official_title>A Stepped-Care Approach to Treating Dental Fear: A Sequential, Multiple Assignment, Randomized Trial for Cognitive-Behavioral Treatment Via Mobile App and Evidence-Based Collaborative Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>New York University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Pennsylvania</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>New York University</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 compare an intervention for dental fear to the usual approach&#xD;
        (i.e., whatever participants' dentist typically does to help participants manage their fear).&#xD;
        The dental fear intervention has 2 separate steps. Step 1 (the less intensive or 'light&#xD;
        touch' intervention step) involves using a mobile application (app). Step 2 consists of a&#xD;
        one-hour telehealth session with a mental health provider tailored to individualized dental&#xD;
        fear.&#xD;
  &#xD;
        This is a randomized study. The time spent participating in the study will depend on which&#xD;
        study condition(s) participants are randomly assigned to. Because this study compares the&#xD;
        dental fear intervention to the standard approach, 25% of participants will not get the&#xD;
        intervention during the study period. These participants (called controls) will be offered&#xD;
        the opportunity to provide feedback about their experiences with dentists. Participants will&#xD;
        be offered the intervention free of charge at the conclusion of the study.&#xD;
  &#xD;
        For each step of the intervention (Dental FearLess app or one-on-one session) relative to&#xD;
        treatment as usual, the investigators hypothesize that participants will show greater&#xD;
        declines in self-reported dental fear and improved oral health-related quality of life at&#xD;
        post-treatment and follow-up period. De-identified attendance records will be collected from&#xD;
        dental practices.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2028</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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reduction of moderate to severe dental fear.</measure>
      <time_frame>baseline, upto 8 weeks, 5/6 month follow-up visit</time_frame>
      <description>Assess the efficacy of a CBT-based stepped-care (i.e., progressive treatment dosing) approach in the reduction of moderate to severe dental fear (measured via subjective report on IDAF).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1250</enrollment>
    <condition>Dental Fear</condition>
    <arm_group>
      <arm_group_label>Dental FearLess App</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dental FearLess app is an e-health intervention that includes psychoeducation about anxiety; affective, cognitive, and behavioral strategies for coping at the dentist.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment as Usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Dental FearLess</intervention_name>
      <description>Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete.</description>
      <arm_group_label>Dental FearLess App</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provide signed and dated informed consent form&#xD;
  &#xD;
            -  Willing to comply with all study procedures and be available for the duration of the&#xD;
               study&#xD;
  &#xD;
            -  Adult, at least 18 years old.&#xD;
  &#xD;
            -  Score 4 or above on the Gatchel single-item dental fear rating scale&#xD;
  &#xD;
            -  Willingness to allow access to dental attendance records&#xD;
  &#xD;
            -  Access to a smartphone or tablet&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Given the scope and nature of the study, there is no exclusion criteria.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Richard Heyman, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>New York University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mark Wolff, DDS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pennsylvania</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kelly Daly, PhD</last_name>
      <phone>914-806-5093</phone>
      <email>kd2691@nyu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>New York University</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10010</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024395
  org study id: 23-042-E
  nct id: NCT06024395
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to compare an intervention for dental fear to the usual approach
        (i.e., whatever participants' dentist typically does to help participants manage their fear).
        The dental fear intervention has 2 separate steps. Step 1 (the less intensive or 'light
        touch' intervention step) involves using a mobile application (app). Step 2 consists of a
        one-hour telehealth session with a mental health provider tailored to individualized dental
        fear.
  
        This is a randomized study. The time spent participating in the study will depend on which
        study condition(s) participants are randomly assigned to. Because this study compares the
        dental fear intervention to the standard approach, 25% of participants will not get the
        intervention during the study period. These participants (called controls) will be offered
        the opportunity to provide feedback about their experiences with dentists. Participants will
        be offered the intervention free of charge at the conclusion of the study.
  
        For each step of the intervention (Dental FearLess app or one-on-one session) relative to
        treatment as usual, the investigators hypothesize that participants will show greater
        declines in self-reported dental fear and improved oral health-related quality of life at
        post-treatment and follow-up period. De-identified attendance records will be collected from
        dental practices.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Reduction of moderate to severe dental fear.
  time frame: baseline, upto 8 weeks, 5/6 month follow-up visit
  description: Assess the efficacy of a CBT-based stepped-care (i.e., progressive treatment dosing) approach in the reduction of moderate to severe dental fear (measured via subjective report on IDAF).
  arm group label: Dental FearLess App
  arm group type: Experimental
  description: Dental FearLess app is an e-health intervention that includes psychoeducation about anxiety; affective, cognitive, and behavioral strategies for coping at the dentist.
  arm group label: Treatment as Usual
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: Dental FearLess
  description: Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete.
  arm group label: Dental FearLess App
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Richard Heyman, Ph.D
  role: Principal Investigator
  affiliation: New York University
  last name: Mark Wolff, DDS
  role: Principal Investigator
  affiliation: University of Pennsylvania
  last name: Kelly Daly, PhD
  phone: 914-806-5093
  email: kd2691@nyu.edu
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  sharing ipd: No