<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/NCT02205177</url>
  </required_header>
  <id_info>
    <org_study_id>13-000288 - PILOT</org_study_id>
    <secondary_id>R34MH100468</secondary_id>
    <nct_id>NCT02205177</nct_id>
  </id_info>
  <brief_title>Youth Mayo Clinic Anxiety Coach Pilot Study</brief_title>
  <official_title>Expanding Access to Therapy for Childhood Anxiety Disorders Via Smart Phones - PILOT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stephen Whiteside</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study aims to test the feasibility and effectiveness of using the Mayo Clinic&#xD;
      Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of&#xD;
      anxiety disorders in youth, particularly those youth who may have limited access to mental&#xD;
      health treatment in the traditional clinical setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study aims to test the feasibility and effectiveness of using the Mayo Clinic&#xD;
      Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of&#xD;
      anxiety disorders in youth, particularly those youth who may have limited access to mental&#xD;
      health treatment in the traditional clinical setting. Therapist will provide CBT to patients&#xD;
      with infrequent face-to-face contact and then will examine the acceptability, ease of use and&#xD;
      need for contact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion</measure>
    <time_frame>Within 5 working days of Treatment Completion</time_frame>
    <description>The Pediatric Anxiety Rating Scale (PARS) is an interview-based tool used to assess for the presence and severity of anxiety symptoms in children and adolescents utilizing parental and youth input to guide clinician ratings. The PARS has 5 questions. Four of those questions has a scale ranging from none (1) to extreme (5). The other question has a rating of 1-5. The total score ranges from 0 - 25, with 25 being the worst.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview</measure>
    <time_frame>Within 5 working days of Treatment Completion</time_frame>
    <description>The number of patients that completed the summary of the qualitative interview will be used to enhance Anxiety Coach</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Face-to-Face w/ Anxiety Coach (FTF-AC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions are expected to initially occur weekly and be within the office although the therapist can leave the office to conduct exposure. The therapist is expected to utilize Anxiety Coach within the session, encourage the patient to use the application to complete homework, and review progress in-session via the web-based portal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Minimal Contact w/ Anxiety Coach (MC-AC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 and up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mayo Clinic Anxiety Coach</intervention_name>
    <description>Mayo Clinic Anxiety Coach is a smartphone application based on cognitive-behavioral treatment for anxiety disorders (i.e., exposure-based therapy) that can be used as 1) a stand-alone treatment requiring minimal provider contact, and 2) an augmentation of face-to-face treatment that increases clinician fidelity and patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence and theory suggesting that information and communication technologies (ICTs) are well-suited for encouraging behavior change through 1) scheduled reminders to engage in therapeutic exercises, 2) point of performance support, 3) individually tailored information, 4) real-time symptom assessment, and 5) readily accessible asynchronous communication.</description>
    <arm_group_label>Face-to-Face w/ Anxiety Coach (FTF-AC)</arm_group_label>
    <arm_group_label>Minimal Contact w/ Anxiety Coach (MC-AC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 7 to 17&#xD;
&#xD;
          2. Primary diagnosis of:&#xD;
&#xD;
               1. social phobia,&#xD;
&#xD;
               2. separation anxiety disorder,&#xD;
&#xD;
               3. panic disorder with and without agoraphobia,&#xD;
&#xD;
               4. specific phobia, or&#xD;
&#xD;
               5. obsessive compulsive disorder&#xD;
&#xD;
          3. A parent or other primary care giver available to participate with the child in all&#xD;
             assessment and treatment activities&#xD;
&#xD;
          4. Estimated average intelligence&#xD;
&#xD;
          5. English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of and/or current diagnosis of:&#xD;
&#xD;
               1. psychosis,&#xD;
&#xD;
               2. autism,&#xD;
&#xD;
               3. bipolar disorder,&#xD;
&#xD;
               4. mental retardation,&#xD;
&#xD;
               5. oppositional defiant disorder,&#xD;
&#xD;
               6. PTSD,&#xD;
&#xD;
               7. selective mutism, or&#xD;
&#xD;
               8. major depressive disorder&#xD;
&#xD;
          2. Current suicidality or recent suicidal behavior&#xD;
&#xD;
          3. Parent to be involved in study who is unable to adequately participate due to&#xD;
             intellectual or psychiatric difficulties&#xD;
&#xD;
          4. Starting or changing the dosage of a psychiatric medication in the last two months&#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>Stephen Whiteside, PhD, LP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <results_first_submitted>March 14, 2019</results_first_submitted>
  <results_first_submitted_qc>August 1, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 5, 2019</results_first_posted>
  <last_update_submitted>August 1, 2019</last_update_submitted>
  <last_update_submitted_qc>August 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Stephen Whiteside</investigator_full_name>
    <investigator_title>Associate Professor of Psychology</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Social Anxiety</keyword>
  <keyword>Social Phobia</keyword>
  <keyword>Separation Anxiety</keyword>
  <keyword>Generalized Anxiety</keyword>
  <keyword>GAD</keyword>
  <keyword>Phobia</keyword>
  <keyword>Panic</keyword>
  <keyword>Agoraphobia</keyword>
  <keyword>Obsessive Compulsive Disorder</keyword>
  <keyword>OCD</keyword>
  <keyword>Child</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Smartphone</keyword>
  <keyword>Teen</keyword>
  <keyword>Youth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02205177/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02205177/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Face-to-Face w/ Anxiety Coach (FTF-AC)</title>
          <description>In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions are expected to initially occur weekly and be within the office although the therapist can leave the office to conduct exposure. The therapist is expected to utilize Anxiety Coach within the session, encourage the patient to use the application to complete homework, &amp; review progress in-session via the web-based portal.&#xD;
Mayo Clinic Anxiety Coach is a smartphone application based on cognitive-behavioral treatment for anxiety disorders (i.e., exposure-based therapy) that can be used as 1) a stand-alone treatment requiring minimal provider contact, and 2) an augmentation of face-to-face treatment that increases clinician fidelity &amp; patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence &amp; theory suggesting that information and communication technologies (ICTs) are well-suited for encouraging</description>
        </group>
        <group group_id="P2">
          <title>Minimal Contact w/ Anxiety Coach (MC-AC)</title>
          <description>In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 &amp; up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol.&#xD;
Mayo Clinic Anxiety Coach: Mayo Clinic Anxiety Coach is a smartphone application based on cognitive-behavioral treatment for anxiety disorders (i.e., exposure-based therapy) that can be used as 1) a stand-alone treatment requiring minimal provider contact, and 2) an augmentation of face-to-face treatment that increases clinician fidelity and patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence and theory suggesting that information and communicatio</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Face-to-Face w/ Anxiety Coach (FTF-AC)</title>
          <description>Therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions occur weekly &amp; within the office. Therapists will use Anxiety Coach at each session, encouraging patients to use the application to complete homework, &amp; review progress in-session via the web-based portal.&#xD;
Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact &amp; an augmentation of face-to-face treatment that increases clinician fidelity &amp; patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence &amp; theory suggesting that information &amp; communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment &amp; readily accessible asynchronous communication.</description>
        </group>
        <group group_id="B2">
          <title>Minimal Contact w/ Anxiety Coach (MC-AC)</title>
          <description>Therapist's will meet with the patient &amp; parent for an initial 50-minute, face-to-face session to give a tutorial on using Anxiety Coach. The therapist will review the patient's progress via the web-based portal &amp; communicate with patients electronically weekly for a total of 6 to 12 weeks of intervention.&#xD;
Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact &amp; an augmentation of face-to-face treatment that increases clinician fidelity &amp; patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence &amp; theory suggesting that information &amp; communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment &amp; readily accessible asynchronous communication.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion</title>
        <description>The Pediatric Anxiety Rating Scale (PARS) is an interview-based tool used to assess for the presence and severity of anxiety symptoms in children and adolescents utilizing parental and youth input to guide clinician ratings. The PARS has 5 questions. Four of those questions has a scale ranging from none (1) to extreme (5). The other question has a rating of 1-5. The total score ranges from 0 - 25, with 25 being the worst.</description>
        <time_frame>Within 5 working days of Treatment Completion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Face-to-Face w/ Anxiety Coach (FTF-AC)</title>
            <description>In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions are expected to initially occur weekly and be within the office although the therapist can leave the office to conduct exposure. The therapist is expected to utilize Anxiety Coach within the session, encourage the patient to use the application to complete homework, and review progress in-session via the web-based portal.</description>
          </group>
          <group group_id="O2">
            <title>Minimal Contact w/ Anxiety Coach (MC-AC)</title>
            <description>In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 and up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion</title>
          <description>The Pediatric Anxiety Rating Scale (PARS) is an interview-based tool used to assess for the presence and severity of anxiety symptoms in children and adolescents utilizing parental and youth input to guide clinician ratings. The PARS has 5 questions. Four of those questions has a scale ranging from none (1) to extreme (5). The other question has a rating of 1-5. The total score ranges from 0 - 25, with 25 being the worst.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" spread="3.1"/>
                    <measurement group_id="O2" value="-1" spread=".7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview</title>
        <description>The number of patients that completed the summary of the qualitative interview will be used to enhance Anxiety Coach</description>
        <time_frame>Within 5 working days of Treatment Completion</time_frame>
        <population>No families from minimal contact responded to interview request. three of the families from the Face to Face condition did not respond to invitation to interview.</population>
        <group_list>
          <group group_id="O1">
            <title>Face-to-Face w/ Anxiety Coach (FTF-AC)</title>
            <description>In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions are expected to initially occur weekly and be within the office although the therapist can leave the office to conduct exposure. The therapist is expected to utilize Anxiety Coach within the session, encourage the patient to use the application to complete homework, and review progress in-session via the web-based portal.</description>
          </group>
          <group group_id="O2">
            <title>Minimal Contact w/ Anxiety Coach (MC-AC)</title>
            <description>In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 and up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview</title>
          <description>The number of patients that completed the summary of the qualitative interview will be used to enhance Anxiety Coach</description>
          <population>No families from minimal contact responded to interview request. three of the families from the Face to Face condition did not respond to invitation to interview.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>11 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Face-to-Face w/ Anxiety Coach (FTF-AC)</title>
          <description>Therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions occur weekly &amp; within the office. Therapists will use Anxiety Coach at each session, encouraging patients to use the application to complete homework, &amp; review progress in-session via the web-based portal.&#xD;
Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact &amp; an augmentation of face-to-face treatment that increases clinician fidelity &amp; patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence &amp; theory suggesting that information &amp; communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment &amp; readily accessible asynchronous communication.</description>
        </group>
        <group group_id="E2">
          <title>Minimal Contact w/ Anxiety Coach (MC-AC)</title>
          <description>Therapist's will meet with the patient &amp; parent for an initial 50-minute, face-to-face session to give a tutorial on using Anxiety Coach. The therapist will review the patient's progress via the web-based portal &amp; communicate with patients electronically weekly for a total of 6 to 12 weeks of intervention.&#xD;
Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact &amp; an augmentation of face-to-face treatment that increases clinician fidelity &amp; patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence &amp; theory suggesting that information &amp; communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment &amp; readily accessible asynchronous communication.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Stephen P Whiteside, PhD, LP</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-2933</phone>
      <email>Whiteside.Stephen@mayo.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02205177
org study id: 13-000288 - PILOT
secondary id: R34MH100468
nct id: NCT02205177
lead sponsor: 
collaborator: 
has dmc: No
This research study aims to test the feasibility and effectiveness of using the Mayo Clinic
      Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of
      anxiety disorders in youth, particularly those youth who may have limited access to mental
      health treatment in the traditional clinical setting.
This research study aims to test the feasibility and effectiveness of using the Mayo Clinic
      Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of
      anxiety disorders in youth, particularly those youth who may have limited access to mental
      health treatment in the traditional clinical setting. Therapist will provide CBT to patients
      with infrequent face-to-face contact and then will examine the acceptability, ease of use and
      need for contact.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion
time frame: Within 5 working days of Treatment Completion
description: The Pediatric Anxiety Rating Scale (PARS) is an interview-based tool used to assess for the presence and severity of anxiety symptoms in children and adolescents utilizing parental and youth input to guide clinician ratings. The PARS has 5 questions. Four of those questions has a scale ranging from none (1) to extreme (5). The other question has a rating of 1-5. The total score ranges from 0 - 25, with 25 being the worst.
measure: Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview
time frame: Within 5 working days of Treatment Completion
description: The number of patients that completed the summary of the qualitative interview will be used to enhance Anxiety Coach
arm group label: Face-to-Face w/ Anxiety Coach (FTF-AC)
arm group type: Active Comparator
description: In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions are expected to initially occur weekly and be within the office although the therapist can leave the office to conduct exposure. The therapist is expected to utilize Anxiety Coach within the session, encourage the patient to use the application to complete homework, and review progress in-session via the web-based portal.
arm group label: Minimal Contact w/ Anxiety Coach (MC-AC)
arm group type: Experimental
description: In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 and up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol.
intervention type: Device
intervention name: Mayo Clinic Anxiety Coach
description: Mayo Clinic Anxiety Coach is a smartphone application based on cognitive-behavioral treatment for anxiety disorders (i.e., exposure-based therapy) that can be used as 1) a stand-alone treatment requiring minimal provider contact, and 2) an augmentation of face-to-face treatment that increases clinician fidelity and patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence and theory suggesting that information and communication technologies (ICTs) are well-suited for encouraging behavior change through 1) scheduled reminders to engage in therapeutic exercises, 2) point of performance support, 3) individually tailored information, 4) real-time symptom assessment, and 5) readily accessible asynchronous communication.
arm group label: Face-to-Face w/ Anxiety Coach (FTF-AC)
arm group label: Minimal Contact w/ Anxiety Coach (MC-AC)
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Stephen Whiteside, PhD, LP
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Stephen Whiteside
investigator title: Associate Professor of Psychology
mesh term: Anxiety Disorders
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 