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/NCT06028984</url>
    </required_header>
    <id_info>
      <org_study_id>BH-SP-01</org_study_id>
      <nct_id>NCT06028984</nct_id>
    </id_info>
    <brief_title>Self-guided Treatment for Depression</brief_title>
    <official_title>Self-guided Treatment for Adolescents/Adults Navigating Depression (STAND-MDD): A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Big Health Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute of Mental Health (NIMH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Big Health Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will examine the efficacy and safety of a self-guided digital therapeutic app for&#xD;
        the adjunct treatment of Major Depressive Disorder compared to a control app in adolescents&#xD;
        and adults.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aims to examine the efficacy of a self-guided digital therapeutic app for&#xD;
        depression compared to a control app in individuals aged 13 and older with a diagnosis of&#xD;
        Major Depressive Disorder. The primary outcomes are patient- and clinician-reported&#xD;
        depression symptom severity after 5 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">March 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Health Questionnaire (PHQ-8)</measure>
      <time_frame>5 weeks post-randomization</time_frame>
      <description>Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Montgomery-Åsberg Depression Rating Scale (MADRS)</measure>
      <time_frame>5 weeks post-randomization</time_frame>
      <description>Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinically important improvement based on the Patient Health Questionnaire (PHQ-8)</measure>
      <time_frame>5 weeks post-randomization, 1-month followup</time_frame>
      <description>5 point or greater reduction in PHQ-8 score from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Response based on the Patient Health Questionnaire (PHQ-8)</measure>
      <time_frame>5 weeks post-randomization, 1-month followup</time_frame>
      <description>50% or greater reduction in PHQ-8 score from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Remission based on the Patient Health Questionnaire (PHQ-8)</measure>
      <time_frame>5 weeks post-randomization, 1-month followup</time_frame>
      <description>PHQ-8 less than 5</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Global improvement assessed using the clinician-rated Clinical Global Impression Scale - Improvement (CGI-I)</measure>
      <time_frame>5 weeks post-randomization, 1-month followup</time_frame>
      <description>A single-item measure scored between 1 and 7 where lower scores indicate greater improvement in global functioning</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Global Impression - Severity (CGI-S)</measure>
      <time_frame>5-weeks post-randomization, 1-month followup</time_frame>
      <description>A single-item measure scored between 1 and 7 where higher scores indicate greater severity of Major Depressive Disorder Symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinically important improvement based on the Montgomery-Åsberg Depression Scale (MADRS)</measure>
      <time_frame>5 weeks post-randomization, 1-month followup</time_frame>
      <description>10 point or greater reduction in MADRS score from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression severity assessed with the Patient Health Questionnaire (PHQ-8) at followup</measure>
      <time_frame>1-, 3- and 6-month followup</time_frame>
      <description>Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinician-rated depression severity as measured by the Montgomery-Åsberg Depression Scale (MADRS) at followup</measure>
      <time_frame>1 month follow up</time_frame>
      <description>Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">248</enrollment>
    <condition>Major Depressive Disorder</condition>
    <arm_group>
      <arm_group_label>Intervention app</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Digitally-delivered self-guided intervention for depression accessed via mobile app</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control app</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>An app based control condition</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Intervention app</intervention_name>
      <description>An app-based intervention for depression</description>
      <arm_group_label>Intervention app</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control app</intervention_name>
      <description>An app with non-therapeutic content</description>
      <arm_group_label>Control app</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Positive self report screen for depression&#xD;
  &#xD;
            -  Participant is at least 13 years of age&#xD;
  &#xD;
            -  Willing and able to provide informed consent; if under 18 years of age, willing and&#xD;
               able to provide assent, and has a legal guardian willing and able to provide consent&#xD;
  &#xD;
            -  Primary diagnosis of Major Depressive Disorder (MDD)&#xD;
  &#xD;
            -  Under the care of a United States (U.S.)-based licensed healthcare provider and&#xD;
               willing and able to provide contact information for the provider and sign a HIPAA&#xD;
               release that allows investigator to contact provider&#xD;
  &#xD;
            -  Fluent and literate in English&#xD;
  &#xD;
            -  Has access to a compatible device and operating system (i.e., capable of installing&#xD;
               the app from the Google Play or Apple App Store) and regular internet access&#xD;
  &#xD;
            -  Located in the continental U.S., Hawaii, or Alaska, and not planning to leave the U.S.&#xD;
               during the primary study period&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has changed or initiated psychotherapy with a mental health professional within 30&#xD;
               days prior to eligibility screening&#xD;
  &#xD;
            -  Has received certain types of psychotherapy within the last 6 months&#xD;
  &#xD;
            -  Has changed prescribed psychotropic medication (initiation or change in dose) within&#xD;
               the past 30 days&#xD;
  &#xD;
            -  Plans to initiate or change treatment (e.g., psychotherapy, psychotropic medication,&#xD;
               and/or other psychosocial treatment) for a mental health disorder during study&#xD;
               intervention period&#xD;
  &#xD;
            -  Suicidal behavior within the past year&#xD;
  &#xD;
            -  Active suicide ideation with intent within the past 3 months&#xD;
  &#xD;
            -  Previously participated in user testing or a clinical study at Limbix Health Inc. or&#xD;
               Big Health Inc. (such as the STAND study or Rise study), or have used a Limbix app&#xD;
  &#xD;
            -  Participated in any other clinical research involving an intervention or treatment&#xD;
               within the past 60 days&#xD;
  &#xD;
            -  Plans to participate in any other clinical research involving an intervention or&#xD;
               treatment during the study intervention period&#xD;
  &#xD;
            -  Living in the same household as another participant in the study (e.g., a sibling)&#xD;
  &#xD;
            -  Has a diagnosis of MDD with psychotic features or comorbid Psychotic Disorder&#xD;
  &#xD;
            -  Has a concurrent diagnosis of (or has been treated for) bipolar disorder I and II or&#xD;
               severe substance use disorder within the past year&#xD;
  &#xD;
            -  Has treatment resistant depression&#xD;
  &#xD;
            -  Is employed by Big Health Inc., or is a collaborator, associate, or relation of Big&#xD;
               Health Inc. staff&#xD;
  &#xD;
            -  Any condition, comorbidity, or event (other than the above) that, in the opinion of&#xD;
               the investigator, will prevent the participant from adhering to the protocol or&#xD;
               benefitting from the intervention, or will prevent investigators from being able to&#xD;
               ensure safety&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Daniella Furman, PhD</last_name>
      <phone>510-833-7578</phone>
      <email>daniella.furman@bighealth.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Aarthi Padmanabhan, PhD</last_name>
      <email>aarthi.padmanabhan@bighealth.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Big Health, Inc.</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94108</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Daniella Furman, PhD</last_name>
        <email>daniella.furman@bighealth.com</email>
      </contact>
      <contact_backup>
        <last_name>Aarthi Padmanabhan, PhD</last_name>
        <email>aarthi.padmanabhan@bighealth.com</email>
      </contact_backup>
      <investigator>
        <last_name>Aarthi Padmanabhan, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Daniella Furman, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Major Depressive Disorder</keyword>
    <keyword>MDD</keyword>
    <keyword>depression</keyword>
    <keyword>digital therapeutic</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Depressive Disorder, Major</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/NCT06028984
  org study id: BH-SP-01
  nct id: NCT06028984
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  This study will examine the efficacy and safety of a self-guided digital therapeutic app for
        the adjunct treatment of Major Depressive Disorder compared to a control app in adolescents
        and adults.
  This study aims to examine the efficacy of a self-guided digital therapeutic app for
        depression compared to a control app in individuals aged 13 and older with a diagnosis of
        Major Depressive Disorder. The primary outcomes are patient- and clinician-reported
        depression symptom severity after 5 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Patient Health Questionnaire (PHQ-8)
  time frame: 5 weeks post-randomization
  description: Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
  measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
  time frame: 5 weeks post-randomization
  description: Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity
  measure: Clinically important improvement based on the Patient Health Questionnaire (PHQ-8)
  time frame: 5 weeks post-randomization, 1-month followup
  description: 5 point or greater reduction in PHQ-8 score from baseline
  measure: Response based on the Patient Health Questionnaire (PHQ-8)
  time frame: 5 weeks post-randomization, 1-month followup
  description: 50% or greater reduction in PHQ-8 score from baseline
  measure: Remission based on the Patient Health Questionnaire (PHQ-8)
  time frame: 5 weeks post-randomization, 1-month followup
  description: PHQ-8 less than 5
  measure: Global improvement assessed using the clinician-rated Clinical Global Impression Scale - Improvement (CGI-I)
  time frame: 5 weeks post-randomization, 1-month followup
  description: A single-item measure scored between 1 and 7 where lower scores indicate greater improvement in global functioning
  measure: Clinical Global Impression - Severity (CGI-S)
  time frame: 5-weeks post-randomization, 1-month followup
  description: A single-item measure scored between 1 and 7 where higher scores indicate greater severity of Major Depressive Disorder Symptoms
  measure: Clinically important improvement based on the Montgomery-Åsberg Depression Scale (MADRS)
  time frame: 5 weeks post-randomization, 1-month followup
  description: 10 point or greater reduction in MADRS score from baseline
  measure: Depression severity assessed with the Patient Health Questionnaire (PHQ-8) at followup
  time frame: 1-, 3- and 6-month followup
  description: Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
  measure: Clinician-rated depression severity as measured by the Montgomery-Åsberg Depression Scale (MADRS) at followup
  time frame: 1 month follow up
  description: Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity
  arm group label: Intervention app
  arm group type: Experimental
  description: Digitally-delivered self-guided intervention for depression accessed via mobile app
  arm group label: Control app
  arm group type: Active Comparator
  description: An app based control condition
  intervention type: Device
  intervention name: Intervention app
  description: An app-based intervention for depression
  arm group label: Intervention app
  intervention type: Other
  intervention name: Control app
  description: An app with non-therapeutic content
  arm group label: Control app
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Daniella Furman, PhD
  phone: 510-833-7578
  email: daniella.furman@bighealth.com
  last name: Aarthi Padmanabhan, PhD
  email: aarthi.padmanabhan@bighealth.com
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Depressive Disorder, Major
  sharing ipd: No