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/NCT06003361</url>
    </required_header>
    <id_info>
      <org_study_id>BH-D-02</org_study_id>
      <nct_id>NCT06003361</nct_id>
    </id_info>
    <brief_title>Rise Study for Depression</brief_title>
    <official_title>Randomized Controlled Trial of a Digital Cognitive Behavioral Therapy Program for Major Depression in Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Big Health Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Big Health Inc.</source>
    <oversight_info>
      <has_dmc>No</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 of digital CBT versus waitlist in improving symptoms for&#xD;
        adults with Major Depressive Disorder.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aims to examine the effectiveness of app-based digital CBT in individuals with a&#xD;
        diagnosis of Major Depressive Disorder. The primary outcomes are depression symptom reduction&#xD;
        and engagement with fulfilling activities after 5 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 31, 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">November 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>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>Environmental Reward Observation Scale (EROS)</measure>
      <time_frame>5 weeks post-randomization</time_frame>
      <description>A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-8)</measure>
      <time_frame>10 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>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montgomery-Åsberg Depression Rating Scale (MADRS)</measure>
      <time_frame>5 and 10 weeks post-randomization</time_frame>
      <description>A validated 10 item observer-rated scale with total scores between 0 and 60 where higher scores indicate greater severity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>World Health Organization 5-item Wellbeing Index (WHO-5)</measure>
      <time_frame>Weeks 5 and 10 post-randomization</time_frame>
      <description>Validated questionnaire; a 5-item scale with raw total scores between 0 and 25 where higher scores indicate greater wellbeing</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Environmental Reward Observation Scale (EROS)</measure>
      <time_frame>10 weeks post-randomization</time_frame>
      <description>A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Major Depressive Disorder</condition>
    <arm_group>
      <arm_group_label>Digital CBT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>digitally-delivered CBT for depression accessed via mobile app</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants will wait for 5 weeks prior to receiving the intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Digital CBT</intervention_name>
      <description>An app-based intervention based on principles from cognitive behavioral therapy for depression.</description>
      <arm_group_label>Digital CBT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Waitlist</intervention_name>
      <description>Participants will wait for 5 weeks prior to receiving the intervention</description>
      <arm_group_label>Waitlist</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults aged ≥22 years old&#xD;
  &#xD;
            -  Score ≥10 and &lt;20 on the 8-item Patient Health Questionnaire (PHQ-8)&#xD;
  &#xD;
            -  Diagnosis of Major Depression&#xD;
  &#xD;
            -  Current resident of the USA&#xD;
  &#xD;
            -  Oral and written fluency in English&#xD;
  &#xD;
            -  Regular access to the internet via a mobile or tablet device using Android (5 or&#xD;
               higher) or iOS (13 or higher)&#xD;
  &#xD;
            -  Participant is able and willing to comply with protocol requirements, has been&#xD;
               informed of the nature of the study, and has signed the IRB-approved informed consent&#xD;
               form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Must not be currently receiving or be expecting to start therapy for depression,&#xD;
               anxiety, or sleep during study participation, or have received therapy for depression,&#xD;
               anxiety, or sleep in the past 12-months&#xD;
  &#xD;
            -  If on psychotropic medication, this must be stable for at least 60 days&#xD;
  &#xD;
            -  Past or present psychosis, schizophrenia, or bipolar disorder&#xD;
  &#xD;
            -  Moderate or greater suicide risk&#xD;
  &#xD;
            -  Treatment-resistant depression&#xD;
  &#xD;
            -  Hearing or vision impairment that prevents effective use of the audio-visual content&#xD;
               of digital CBT or psychoeducation&#xD;
  &#xD;
            -  Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that&#xD;
               would prevent participants from following study procedures&#xD;
  &#xD;
            -  Any condition that the investigator believes would make participation in the study not&#xD;
               in the best interest of the subject or would preclude successful completion of study&#xD;
               activities&#xD;
  &#xD;
            -  Other exclusion criteria may apply&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Tali Ball, PhD</last_name>
      <phone>(510)853-9139</phone>
      <email>risestudy@bighealth.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Big Health Inc.</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94108</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tali Ball, PhD</last_name>
        <email>risestudy@bighealth.com</email>
      </contact>
      <investigator>
        <last_name>Tali Ball, 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 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 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>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/NCT06003361
  org study id: BH-D-02
  nct id: NCT06003361
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  This study will examine the efficacy of digital CBT versus waitlist in improving symptoms for
        adults with Major Depressive Disorder.
  This study aims to examine the effectiveness of app-based digital CBT in individuals with a
        diagnosis of Major Depressive Disorder. The primary outcomes are depression symptom reduction
        and engagement with fulfilling activities after 5 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  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: Environmental Reward Observation Scale (EROS)
  time frame: 5 weeks post-randomization
  description: A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities
  measure: Patient Health Questionnaire (PHQ-8)
  time frame: 10 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 and 10 weeks post-randomization
  description: A validated 10 item observer-rated scale with total scores between 0 and 60 where higher scores indicate greater severity
  measure: World Health Organization 5-item Wellbeing Index (WHO-5)
  time frame: Weeks 5 and 10 post-randomization
  description: Validated questionnaire; a 5-item scale with raw total scores between 0 and 25 where higher scores indicate greater wellbeing
  measure: Environmental Reward Observation Scale (EROS)
  time frame: 10 weeks post-randomization
  description: A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities
  arm group label: Digital CBT
  arm group type: Experimental
  description: digitally-delivered CBT for depression accessed via mobile app
  arm group label: Waitlist
  arm group type: Other
  description: Participants will wait for 5 weeks prior to receiving the intervention
  intervention type: Device
  intervention name: Digital CBT
  description: An app-based intervention based on principles from cognitive behavioral therapy for depression.
  arm group label: Digital CBT
  intervention type: Other
  intervention name: Waitlist
  description: Participants will wait for 5 weeks prior to receiving the intervention
  arm group label: Waitlist
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tali Ball, PhD
  phone: (510)853-9139
  email: risestudy@bighealth.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Depressive Disorder
  mesh term: Depressive Disorder, Major
  sharing ipd: No