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/NCT05987969</url>
    </required_header>
    <id_info>
      <org_study_id>Alena App RCT 2023 #1</org_study_id>
      <nct_id>NCT05987969</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of the Alena App as a Treatment for Social Anxiety Disorder</brief_title>
    <official_title>Efficacy, Tolerability and Safety of a Smartphone-delivered, Fully Automatic Cognitive Behavioural Therapy Programme for Social Anxiety</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aya Technologies Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aya Technologies Limited</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 present study is a randomised controlled trial that seeks to investigate the efficacy and&#xD;
        safety of the Alena app as a treatment for social anxiety disorder.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This will be a 10-week web-based parallel-group unblinded randomised controlled trial with an&#xD;
        8-week intervention period and a 2-week follow-up post-intervention. Participants will be&#xD;
        randomly allocated to receive access to the Alena app or to a wait list control group, in a&#xD;
        1:1 ratio. The Alena app primarily comprises CBT-based therapy for social anxiety based on&#xD;
        the Clark and Wells model, as well as cognitive assessments, calming exercises and a&#xD;
        community forum.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 20, 2023</start_date>
    <completion_date type="Actual">June 7, 2023</completion_date>
    <primary_completion_date type="Actual">June 7, 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>Change in Social Phobia Inventory (SPIN)</measure>
      <time_frame>Change from baseline SPIN at 8 weeks</time_frame>
      <description>The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Work and Social Adjustment Scale (WSAS)</measure>
      <time_frame>Change from baseline WSAS at 8 weeks</time_frame>
      <description>The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day activities, such as work, home management and social leisure activities.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Social Phobia Inventory (SPIN)</measure>
      <time_frame>Change from SPIN level at the end of the intervention period at 4 weeks later</time_frame>
      <description>The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear,</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Work and Social Adjustment Scale (WSAS)</measure>
      <time_frame>At the follow-up point of 4 weeks after the end of the intervention period.</time_frame>
      <description>The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serious adverse events</measure>
      <time_frame>Within the intervention period of 8 weeks</time_frame>
      <description>Serious adverse events are defined as those that meet the criteria for ISO:14155(A:14)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">250</enrollment>
    <condition>Social Anxiety Disorder (Social Phobia)</condition>
    <condition>Social Anxiety</condition>
    <condition>Social Anxiety Disorder</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Access to the &quot;Alena&quot; CBT-based mobile application intervention for 8 weeks. Instructed to complete one of the 4 main modules every 2 weeks. Also asked to complete one additional short exercise per week and engage with one forum post per week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Wait list control - Given access to the intervention at the end of the 10-week trial period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>&quot;Alena&quot; mobile application</intervention_name>
      <description>This mobile application primarily comprises CBT-based therapy for social anxiety based on the Clark and Wells model, as well as cognitive assessments, calming exercises and a community forum.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Scored over 30 on the SPIN (indicating at least moderate social anxiety)&#xD;
  &#xD;
            -  Aged 18 or over&#xD;
  &#xD;
            -  Fluent in English&#xD;
  &#xD;
            -  Has access to a smartphone (iOS or Android) and the internet&#xD;
  &#xD;
            -  UK resident&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Currently receiving therapy for their mental health&#xD;
  &#xD;
            -  Mental health medication has changed (dosage or presence) in the last 8 weeks&#xD;
  &#xD;
            -  Scores over 7 on the AUDIT-C and/or yes on either drug dependence question taken from&#xD;
               the DUDIT (indicating drug or alcohol abuse)&#xD;
  &#xD;
            -  Previous experience with the Alena app through prior studies or user testing&#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>
    <location>
      <facility>
        <name>Aya Technologies Limited</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>RCT</keyword>
    <keyword>mobile applications</keyword>
    <keyword>social anxiety</keyword>
    <keyword>mental health</keyword>
    <keyword>social anxiety disorder</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
      <mesh_term>Phobia, Social</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/NCT05987969
  org study id: Alena App RCT 2023 #1
  nct id: NCT05987969
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present study is a randomised controlled trial that seeks to investigate the efficacy and
        safety of the Alena app as a treatment for social anxiety disorder.
  This will be a 10-week web-based parallel-group unblinded randomised controlled trial with an
        8-week intervention period and a 2-week follow-up post-intervention. Participants will be
        randomly allocated to receive access to the Alena app or to a wait list control group, in a
        1:1 ratio. The Alena app primarily comprises CBT-based therapy for social anxiety based on
        the Clark and Wells model, as well as cognitive assessments, calming exercises and a
        community forum.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Social Phobia Inventory (SPIN)
  time frame: Change from baseline SPIN at 8 weeks
  description: The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components.
  measure: Change in Work and Social Adjustment Scale (WSAS)
  time frame: Change from baseline WSAS at 8 weeks
  description: The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day activities, such as work, home management and social leisure activities.
  measure: Change in Social Phobia Inventory (SPIN)
  time frame: Change from SPIN level at the end of the intervention period at 4 weeks later
  description: The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear,
  measure: Work and Social Adjustment Scale (WSAS)
  time frame: At the follow-up point of 4 weeks after the end of the intervention period.
  description: The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day
  measure: Serious adverse events
  time frame: Within the intervention period of 8 weeks
  description: Serious adverse events are defined as those that meet the criteria for ISO:14155(A:14)
  arm group label: Intervention
  arm group type: Experimental
  description: Access to the "Alena" CBT-based mobile application intervention for 8 weeks. Instructed to complete one of the 4 main modules every 2 weeks. Also asked to complete one additional short exercise per week and engage with one forum post per week.
  arm group label: No intervention
  arm group type: No Intervention
  description: Wait list control - Given access to the intervention at the end of the 10-week trial period.
  intervention type: Other
  intervention name: "Alena" mobile application
  description: This mobile application primarily comprises CBT-based therapy for social anxiety based on the Clark and Wells model, as well as cognitive assessments, calming exercises and a community forum.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Anxiety Disorders
  mesh term: Phobia, Social
  sharing ipd: No