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/NCT06010654</url>
    </required_header>
    <id_info>
      <org_study_id>3-2023-0018</org_study_id>
      <nct_id>NCT06010654</nct_id>
    </id_info>
    <brief_title>Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder</brief_title>
    <official_title>A Single Blind, Parallel Arm, Single Institution Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>HAII corp.ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>HAII corp.ltd</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 investigators propose to develop and adapt 'ANZEILAX' smartphone app specifically for&#xD;
        individuals with Generalized anxiety disorder. The study will measure the therapeutic effects&#xD;
        and safety of 'ANZEILAX' on symptoms of anxiety using pre- and post-treatment scores for&#xD;
        generalized anxiety disorder and other physical, emotional, and cognitive symptoms of anxiety&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">April 4, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 29, 2024</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Generalized Anxiety Disorder-7</measure>
      <time_frame>Baseline assessment, Week 5, Week 10, Week 15</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Beck Anxiety Inventory</measure>
      <time_frame>Baseline assessment, Week 5, Week 10, Week 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Penn State Worry Questionnaire</measure>
      <time_frame>Baseline assessment, Week 5, Week 10, Week 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Anxiety and Depression Scale</measure>
      <time_frame>Baseline assessment, Week 5, Week 10, Week 15</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment adherence</measure>
      <time_frame>Week 5, Week 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction evaluation</measure>
      <time_frame>Week 5, Week 10</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Generalized Anxiety Disorder</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The general treatment of the standard treatment method and the test device that provides self-talk training based on acceptance and commitment therapy (ACT) are used concurrently for 10 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Treatment as usual (TAU) is a standard treatment for 10 weeks, which is the clinical trial period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Software as a Medical device</intervention_name>
      <description>The test device is a software medical device designed for the purpose of treating generalized anxiety disorder that provides self-talk training based on acceptance and commitment therapy (ACT). Use 2 sets per day for 10 weeks with generalized treatment of standard treatment method.</description>
      <arm_group_label>Experimental Group</arm_group_label>
      <other_name>ANZEILAX</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          People can participate in this clinical trial only if following criteria are met.&#xD;
  &#xD;
            1. Adults aged 19 years or older with a high school diploma or higher&#xD;
  &#xD;
            2. Disease groups according to the criteria below:&#xD;
  &#xD;
                 -  A person diagnosed with Generalized Anxiety Disorder (DSM-5 (ICD-10) code: 300.02&#xD;
                    (F41.1))&#xD;
  &#xD;
                 -  Those who are classified as moderate or severe with 10 points or more through&#xD;
                    GAD-7&#xD;
  &#xD;
                 -  Those taking prescription drugs related to generalized anxiety disorder&#xD;
  &#xD;
            3. A group of disorders with generalized anxiety disorder, or a group of disorders with&#xD;
               worry that is a major symptom of generalized anxiety disorder in any of the following&#xD;
               criteria:&#xD;
  &#xD;
                 -  Those suffering from other anxiety disorders such as panic disorder and social&#xD;
                    anxiety disorder&#xD;
  &#xD;
                 -  Those suffering from major depressive disorder accompanied by worry, the main&#xD;
                    symptom of generalized anxiety disorder&#xD;
  &#xD;
            4. A person who fully understands the purpose, contents, and process of the clinical&#xD;
               trial, agrees to participate, and signs the consent form in handwriting&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          If any of the following criteria is applicable, the person cannot participate in this&#xD;
          clinical trial.&#xD;
  &#xD;
            1. Those who cannot read the consent form&#xD;
  &#xD;
            2. Those who are inexperienced in using smartphones&#xD;
  &#xD;
            3. In case of psychiatric symptoms or history (including schizophrenia, psychosis,&#xD;
               bipolar disorder, epilepsy)&#xD;
  &#xD;
            4. In case of brain damage, cognitive impairment, or neurological disease&#xD;
  &#xD;
            5. In case of intellectual disability&#xD;
  &#xD;
            6. Having a substance and alcohol use disorder&#xD;
  &#xD;
            7. Suicidal intent, suicidal ideation, or self-injurious behavior in the past 6 months&#xD;
  &#xD;
            8. Receiving cognitive behavioral therapy for anxiety, depression or mood disorders, or&#xD;
               participating in such therapy in the past 3 months&#xD;
  &#xD;
            9. Those who are registered in other clinical studies&#xD;
  &#xD;
           10. Other investigators judged that the conduct of this clinical trial was inappropriate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Yonsei University Health System, Gangnam Severance Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>06273</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>KIM</last_name>
        <phone>+820220193341</phone>
        <email>jaejkim@yuhs.ac</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
  
  
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/NCT06010654
  org study id: 3-2023-0018
  nct id: NCT06010654
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The investigators propose to develop and adapt 'ANZEILAX' smartphone app specifically for
        individuals with Generalized anxiety disorder. The study will measure the therapeutic effects
        and safety of 'ANZEILAX' on symptoms of anxiety using pre- and post-treatment scores for
        generalized anxiety disorder and other physical, emotional, and cognitive symptoms of anxiety
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Generalized Anxiety Disorder-7
  time frame: Baseline assessment, Week 5, Week 10, Week 15
  measure: Beck Anxiety Inventory
  time frame: Baseline assessment, Week 5, Week 10, Week 15
  measure: Penn State Worry Questionnaire
  time frame: Baseline assessment, Week 5, Week 10, Week 15
  measure: Hospital Anxiety and Depression Scale
  time frame: Baseline assessment, Week 5, Week 10, Week 15
  measure: Treatment adherence
  time frame: Week 5, Week 10
  measure: Satisfaction evaluation
  time frame: Week 5, Week 10
  arm group label: Experimental Group
  arm group type: Experimental
  description: The general treatment of the standard treatment method and the test device that provides self-talk training based on acceptance and commitment therapy (ACT) are used concurrently for 10 weeks.
  arm group label: Control Group
  arm group type: No Intervention
  description: Treatment as usual (TAU) is a standard treatment for 10 weeks, which is the clinical trial period.
  intervention type: Device
  intervention name: Software as a Medical device
  description: The test device is a software medical device designed for the purpose of treating generalized anxiety disorder that provides self-talk training based on acceptance and commitment therapy (ACT). Use 2 sets per day for 10 weeks with generalized treatment of standard treatment method.
  arm group label: Experimental Group
  other name: ANZEILAX
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Anxiety Disorders
  sharing ipd: No