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/NCT06021821</url>
    </required_header>
    <id_info>
      <org_study_id>20288</org_study_id>
      <nct_id>NCT06021821</nct_id>
    </id_info>
    <brief_title>A Randomized-Controlled Trial to Investigate the Effect of a Novel Music Therapy Application to Reduce Anxiety and Stress</brief_title>
    <official_title>A Randomized-Controlled Trial to Investigate the Effect of a Novel Music Therapy Application to Reduce Anxiety and Stress</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>SoundMind</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Citruslabs</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>SoundMind</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 virtual, open-label, three-group, randomized-controlled trial will last six weeks.&#xD;
        Participants will be allocated into three groups; the Intervention Group, Spotify Group, and&#xD;
        Control Group. All participants will complete a baseline questionnaire before completing&#xD;
        their designated regime daily for six weeks. In addition, participants will complete&#xD;
        study-specific surveys and validated questionnaires at the end of each week (Week 1, 2, 3, 4,&#xD;
        5 &amp; 6). The study will include 75 [participants in total, 25 per group, who all have&#xD;
        self-reported concerns around anxiety, stress, or depression.&#xD;
  &#xD;
        Questionnaires will be used to monitor sleep, cognitive ability, and changes in symptoms of&#xD;
        anxiety, depression, and stress. Both study-specific questionnaires and validated&#xD;
        questionnaires will be utilized, including the Generalized Anxiety Disorder Assessment&#xD;
        (GAD-7), the 9-question Patient Health Questionnaire (PHQ-9), Perceived Stress Scale (PSS),&#xD;
        and The World Health Organisation- Five Well-Being Index (WHO-5). Likert scale responses will&#xD;
        be examined from baseline to each check-in. Participant responses on product feedback will be&#xD;
        presented as % scores.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 29, 2023</start_date>
    <completion_date type="Actual">July 26, 2023</completion_date>
    <primary_completion_date type="Actual">July 26, 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>
      <intervention_model_description>Three-group study.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in scores on the Generalized Anxiety Disorder 7-item scale (GAD-7). [Baseline to Week 6]</measure>
      <time_frame>6 weeks</time_frame>
      <description>The GAD-7 is a self-report questionnaire used to assess the severity of generalized anxiety disorder. It consists of seven questions that ask about the frequency and intensity of common symptoms of anxiety over the past two weeks. Each question is scored on a scale from 0 to 3, with the total scores ranging from 0 to 21. The scoring is typically interpreted as follows:&#xD;
  0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in scores on the Patient Health Questionnaire-9 (PHQ-9). [Baseline to Week 6]</measure>
      <time_frame>6 weeks</time_frame>
      <description>The PHQ-9 is a self-report questionnaire used to assess the severity of depression symptoms. Each question is scored on a scale from 0 to 3, with the total scores ranging from 0 to 27. The scoring is typically interpreted as follows:&#xD;
  0-4: Minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in scores on the Perceived Stress Scale (PSS). [Baseline to Week 6]</measure>
      <time_frame>6 weeks</time_frame>
      <description>The PSS is a widely used self-report questionnaire designed to measure an individual's perception of stress in their life. Higher scores indicate higher perceived stress.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in scores on the World Health Organization Well-Being Index (WHO-5). [Baseline to Week 6]</measure>
      <time_frame>6 weeks</time_frame>
      <description>The WHO-5, or World Health Organization Well-Being Index, is a self-reported questionnaire used to measure psychological well-being and mood. Respondents are asked to rate statements on a scale from 0 to 5, where 0 indicates &quot;at no time&quot; and 5 indicates &quot;all of the time.&quot; The scores are summed, resulting in a total score that can range from 0 to 25. A total score of 0-13 suggests poor well-being and a higher risk of depression.&#xD;
  A total score of 14-17 indicates moderate well-being. A total score of 18-25 suggests good well-being.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in participant-perceived sleep quality. [Baseline to Week 6]</measure>
      <time_frame>6 weeks</time_frame>
      <description>Survey-based assessment of participants' perception of their sleep quality.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">75</enrollment>
    <condition>Anxiety</condition>
    <condition>Depression</condition>
    <condition>Stress</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will listen to the SoundMind app for 20 minutes per day, ideally during a moment of stress.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Spotify Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will listen to a specified Spotify playlist for 20 minutes per day, ideally during a moment of stress.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will have no tasks prescribed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>SoundMind App</intervention_name>
      <description>he SoundMind application uses binaural beats to encourage relaxation, focus, and alertness.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Spotify Playlist</intervention_name>
      <description>Participants will listen to a &quot;calm vibes&quot; playlist by Spotify.</description>
      <arm_group_label>Spotify Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  Between 18-28 years of age&#xD;
  &#xD;
            -  Self-reported concerns around anxiety, stress, or depression&#xD;
  &#xD;
            -  Generally healthy - don't live with any uncontrolled chronic disease&#xD;
  &#xD;
            -  Must have headphones&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any pre-existing chronic conditions that would prevent participants from adhering to&#xD;
               the protocol, including oncological and psychiatric disorders&#xD;
  &#xD;
            -  Women who are pregnant, breastfeeding or attempting to become pregnant&#xD;
  &#xD;
            -  Unwilling to follow the study protocol&#xD;
  &#xD;
            -  Testing any other product for any other research studies at the same time&#xD;
  &#xD;
            -  History of epilepsy or seizures&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>28 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Citruslabs</name>
        <address>
          <city>Santa Monica</city>
          <state>California</state>
          <zip>90404</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 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>Undecided</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/NCT06021821
  org study id: 20288
  nct id: NCT06021821
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This virtual, open-label, three-group, randomized-controlled trial will last six weeks.
        Participants will be allocated into three groups; the Intervention Group, Spotify Group, and
        Control Group. All participants will complete a baseline questionnaire before completing
        their designated regime daily for six weeks. In addition, participants will complete
        study-specific surveys and validated questionnaires at the end of each week (Week 1, 2, 3, 4,
        5 & 6). The study will include 75 [participants in total, 25 per group, who all have
        self-reported concerns around anxiety, stress, or depression.
  
        Questionnaires will be used to monitor sleep, cognitive ability, and changes in symptoms of
        anxiety, depression, and stress. Both study-specific questionnaires and validated
        questionnaires will be utilized, including the Generalized Anxiety Disorder Assessment
        (GAD-7), the 9-question Patient Health Questionnaire (PHQ-9), Perceived Stress Scale (PSS),
        and The World Health Organisation- Five Well-Being Index (WHO-5). Likert scale responses will
        be examined from baseline to each check-in. Participant responses on product feedback will be
        presented as % scores.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Three-group study.
  primary purpose: Other
  masking: None (Open Label)
  measure: Change in scores on the Generalized Anxiety Disorder 7-item scale (GAD-7). [Baseline to Week 6]
  time frame: 6 weeks
  description: The GAD-7 is a self-report questionnaire used to assess the severity of generalized anxiety disorder. It consists of seven questions that ask about the frequency and intensity of common symptoms of anxiety over the past two weeks. Each question is scored on a scale from 0 to 3, with the total scores ranging from 0 to 21. The scoring is typically interpreted as follows:
  0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety
  measure: Change in scores on the Patient Health Questionnaire-9 (PHQ-9). [Baseline to Week 6]
  time frame: 6 weeks
  description: The PHQ-9 is a self-report questionnaire used to assess the severity of depression symptoms. Each question is scored on a scale from 0 to 3, with the total scores ranging from 0 to 27. The scoring is typically interpreted as follows:
  0-4: Minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression
  measure: Change in scores on the Perceived Stress Scale (PSS). [Baseline to Week 6]
  time frame: 6 weeks
  description: The PSS is a widely used self-report questionnaire designed to measure an individual's perception of stress in their life. Higher scores indicate higher perceived stress.
  measure: Change in scores on the World Health Organization Well-Being Index (WHO-5). [Baseline to Week 6]
  time frame: 6 weeks
  description: The WHO-5, or World Health Organization Well-Being Index, is a self-reported questionnaire used to measure psychological well-being and mood. Respondents are asked to rate statements on a scale from 0 to 5, where 0 indicates "at no time" and 5 indicates "all of the time." The scores are summed, resulting in a total score that can range from 0 to 25. A total score of 0-13 suggests poor well-being and a higher risk of depression.
  A total score of 14-17 indicates moderate well-being. A total score of 18-25 suggests good well-being.
  measure: Changes in participant-perceived sleep quality. [Baseline to Week 6]
  time frame: 6 weeks
  description: Survey-based assessment of participants' perception of their sleep quality.
  arm group label: Intervention Group
  arm group type: Experimental
  description: Participants will listen to the SoundMind app for 20 minutes per day, ideally during a moment of stress.
  arm group label: Spotify Group
  arm group type: Active Comparator
  description: Participants will listen to a specified Spotify playlist for 20 minutes per day, ideally during a moment of stress.
  arm group label: Control Group
  arm group type: No Intervention
  description: This group will have no tasks prescribed.
  intervention type: Other
  intervention name: SoundMind App
  description: he SoundMind application uses binaural beats to encourage relaxation, focus, and alertness.
  arm group label: Intervention Group
  intervention type: Other
  intervention name: Spotify Playlist
  description: Participants will listen to a "calm vibes" playlist by Spotify.
  arm group label: Spotify Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 28 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Anxiety Disorders
  sharing ipd: Undecided