<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/NCT02205203</url>
  </required_header>
  <id_info>
    <org_study_id>13-000288 - RCT</org_study_id>
    <secondary_id>R34MH100468</secondary_id>
    <nct_id>NCT02205203</nct_id>
  </id_info>
  <brief_title>Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial</brief_title>
  <official_title>Expanding Access to Therapy for Childhood Anxiety Disorders Via Smart Phones - RCT</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </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>
      60 therapists in underserved areas will treat children with anxiety disorders in one of three&#xD;
      conditions (treatment as usual, Anxiety Coach with face-to-face therapy, or Anxiety Coach&#xD;
      with minimal direct contact) to determine the feasibility of using of Anxiety Coach to&#xD;
      increase the frequency of exposure and improve outcomes with varying degrees of face-to-face&#xD;
      contact (N = 60 patients).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</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>Double (Investigator, 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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">145</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 Mayo Clinic 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>Treatment as Usual (TAU)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the TAU condition therapists provide treatment consistent with their orientation and clinical judgment. Previous research suggests that TAU will include supportive therapy, relaxation, and cognitive restructuring. The format of treatment will be 6 to 12, 50-minute, face-to-face therapy sessions in the therapist's office, with flexibility to leave the office (e.g., for exposure). Therapists can communicate with patients between sessions (e.g., phone calls), as long as this medium is not the primary mode of treatment.</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>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>In the TAU condition therapists provide treatment consistent with their orientation and clinical judgment. Previous research suggests that TAU will include supportive therapy, relaxation, and cognitive restructuring. The format of treatment will be 6 to 12, 50-minute, face-to-face therapy sessions in the therapist's office, with flexibility to leave the office (e.g., for exposure).</description>
    <arm_group_label>Treatment as Usual (TAU)</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, Ph.D., L.P.</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>
  <link>
    <url>http://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>March 2021</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>
  <last_update_submitted>March 24, 2021</last_update_submitted>
  <last_update_submitted_qc>March 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2021</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>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>
  <!-- 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/NCT02205203
org study id: 13-000288 - RCT
secondary id: R34MH100468
nct id: NCT02205203
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: 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.
60 therapists in underserved areas will treat children with anxiety disorders in one of three
      conditions (treatment as usual, Anxiety Coach with face-to-face therapy, or Anxiety Coach
      with minimal direct contact) to determine the feasibility of using of Anxiety Coach to
      increase the frequency of exposure and improve outcomes with varying degrees of face-to-face
      contact (N = 60 patients).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, 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.
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 Mayo Clinic 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: Treatment as Usual (TAU)
arm group type: Experimental
description: In the TAU condition therapists provide treatment consistent with their orientation and clinical judgment. Previous research suggests that TAU will include supportive therapy, relaxation, and cognitive restructuring. The format of treatment will be 6 to 12, 50-minute, face-to-face therapy sessions in the therapist's office, with flexibility to leave the office (e.g., for exposure). Therapists can communicate with patients between sessions (e.g., phone calls), as long as this medium is not the primary mode of treatment.
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)
intervention type: Other
intervention name: Treatment as Usual
description: In the TAU condition therapists provide treatment consistent with their orientation and clinical judgment. Previous research suggests that TAU will include supportive therapy, relaxation, and cognitive restructuring. The format of treatment will be 6 to 12, 50-minute, face-to-face therapy sessions in the therapist's office, with flexibility to leave the office (e.g., for exposure).
arm group label: Treatment as Usual (TAU)
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Stephen Whiteside, Ph.D., L.P.
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: http://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Stephen Whiteside
investigator title: Professor of Psychology
mesh term: Anxiety Disorders
sharing ipd: No