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/NCT06013137</url>
    </required_header>
    <id_info>
      <org_study_id>02000591</org_study_id>
      <nct_id>NCT06013137</nct_id>
    </id_info>
    <brief_title>Chatbot for Depression, Anxiety, and Eating Disorders</brief_title>
    <official_title>Testing an Artificial Intelligence Chatbot for Mental Health</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dartmouth-Hitchcock Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dartmouth-Hitchcock Medical Center</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The research team would like to test how efficacious an artificial intelligence chatbot is in&#xD;
        delivering supportive behavioral interventions in populations with anxiety, depression, or&#xD;
        eating concerns.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research team has developed a deep learning-powered application that can provide support&#xD;
        and therapeutic suggestions via natural dialogue. The chatbot is designed to be highly&#xD;
        scalable such that it could address access issues (to address the majority of persons who do&#xD;
        not not have access to therapy). Eventually, it is hoped this intervention can provide&#xD;
        accessible therapy for those with anxiety, depression, and eating disorders, among other&#xD;
        mental illnesses. The chatbot has been trained with intervention-oriented text conversations&#xD;
        written by research assistants, employing a variety of therapeutic techniques, including&#xD;
        cognitive-behavioral therapy. The research team hopes to test how well the chatbot can&#xD;
        respond and aid those with mental health symptoms. The chatbot's effectiveness will be&#xD;
        monitored based on the participants' interactions with the chatbot, as well as the&#xD;
        participants' scores on the PHQ-9, GAD-IV, EDE-QS, and general satisfactory questionnaires.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 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>Anxiety Symptoms</measure>
      <time_frame>Each participant in the anxiety cohort will fill out an anxiety questionnaire to establish baseline symptoms, and they will fill out this questionnaire again after 4 and 8 weeks of using the therapy chatbot to track changes in their symptoms.</time_frame>
      <description>Anxiety symptoms will be measured with the GAD-IV.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depressive Symptoms</measure>
      <time_frame>Each participant in the depression cohort will fill out a questionnaire to establish baseline symptoms, and they will fill out this questionnaire again after 4 and 8 weeks of using the therapy chatbot to track changes in their symptoms.</time_frame>
      <description>Depressive symptoms will be measured with the PHQ-9.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Eating Disorders Symptoms</measure>
      <time_frame>Each participant in the eating disorders cohort will fill out a questionnaire to establish baseline symptoms, and they will fill out this questionnaire again after 4 and 8 weeks of using the therapy chatbot to track changes in their symptoms.</time_frame>
      <description>Eating Disorders symptoms will be measured with the EDE-QS.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">210</enrollment>
    <condition>Depression</condition>
    <condition>Anxiety</condition>
    <condition>Eating Disorders</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will have access to the Therabot smartphone application. They will interact with the generative chatbot daily to discuss their mental health. Each participant in this group will have some benchmark symptoms of depression, anxiety, or eating disorders. They will fill out questionnaires every 4 weeks to describe changes in symptoms.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will not have access to the Therabot App. They will fill out questionnaires every 4 weeks to describe changes in symptoms. Each participant in this group will have some benchmark symptoms of depression, anxiety, or eating disorders.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Therabot</intervention_name>
      <description>The participants assigned to the experimental group will interact with an artificial intelligence therapy chatbot to alleviate symptoms associated with depression, anxiety, and eating disorders. The control group will not have access to this smartphone chatbot app.</description>
      <arm_group_label>Experimental</arm_group_label>
      <other_name>Artificial Intelligence Chatbot</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  We will recruit participants online using Facebook, Google Ads, Reddit, MTurk,&#xD;
               listservs, and other online platforms.&#xD;
  &#xD;
            -  These individuals must meet the criteria for anxiety, depression or disordered eating,&#xD;
               according to the PHQ-9, GADQ-IV, and SWED 3.0.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals currently being treated for active suicidality (measured with C-SSRS),&#xD;
               Bipolar I/II, and active psychosis will be excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nicholas C Jacobson, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nicholas C Jacobson, PhD</last_name>
      <phone>+1(603)-646-7015</phone>
      <email>nicholas.c.jacobson@dartmouth.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sukanya Bhattacharya</last_name>
      <phone>603-646-6306</phone>
      <phone_ext>66306</phone_ext>
      <email>sukanya.bhattacharya.24@dartmouth.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
      <investigator_full_name>Nicholas C. Jacobson</investigator_full_name>
      <investigator_title>Dr. Nicholas Jacobson</investigator_title>
    </responsible_party>
    <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>Feeding and Eating 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/NCT06013137
  org study id: 02000591
  nct id: NCT06013137
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The research team would like to test how efficacious an artificial intelligence chatbot is in
        delivering supportive behavioral interventions in populations with anxiety, depression, or
        eating concerns.
  The research team has developed a deep learning-powered application that can provide support
        and therapeutic suggestions via natural dialogue. The chatbot is designed to be highly
        scalable such that it could address access issues (to address the majority of persons who do
        not not have access to therapy). Eventually, it is hoped this intervention can provide
        accessible therapy for those with anxiety, depression, and eating disorders, among other
        mental illnesses. The chatbot has been trained with intervention-oriented text conversations
        written by research assistants, employing a variety of therapeutic techniques, including
        cognitive-behavioral therapy. The research team hopes to test how well the chatbot can
        respond and aid those with mental health symptoms. The chatbot's effectiveness will be
        monitored based on the participants' interactions with the chatbot, as well as the
        participants' scores on the PHQ-9, GAD-IV, EDE-QS, and general satisfactory questionnaires.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Anxiety Symptoms
  time frame: Each participant in the anxiety cohort will fill out an anxiety questionnaire to establish baseline symptoms, and they will fill out this questionnaire again after 4 and 8 weeks of using the therapy chatbot to track changes in their symptoms.
  description: Anxiety symptoms will be measured with the GAD-IV.
  measure: Depressive Symptoms
  time frame: Each participant in the depression cohort will fill out a questionnaire to establish baseline symptoms, and they will fill out this questionnaire again after 4 and 8 weeks of using the therapy chatbot to track changes in their symptoms.
  description: Depressive symptoms will be measured with the PHQ-9.
  measure: Eating Disorders Symptoms
  time frame: Each participant in the eating disorders cohort will fill out a questionnaire to establish baseline symptoms, and they will fill out this questionnaire again after 4 and 8 weeks of using the therapy chatbot to track changes in their symptoms.
  description: Eating Disorders symptoms will be measured with the EDE-QS.
  arm group label: Experimental
  arm group type: Experimental
  description: This group will have access to the Therabot smartphone application. They will interact with the generative chatbot daily to discuss their mental health. Each participant in this group will have some benchmark symptoms of depression, anxiety, or eating disorders. They will fill out questionnaires every 4 weeks to describe changes in symptoms.
  arm group label: Control
  arm group type: No Intervention
  description: This group will not have access to the Therabot App. They will fill out questionnaires every 4 weeks to describe changes in symptoms. Each participant in this group will have some benchmark symptoms of depression, anxiety, or eating disorders.
  intervention type: Other
  intervention name: Therabot
  description: The participants assigned to the experimental group will interact with an artificial intelligence therapy chatbot to alleviate symptoms associated with depression, anxiety, and eating disorders. The control group will not have access to this smartphone chatbot app.
  arm group label: Experimental
  other name: Artificial Intelligence Chatbot
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nicholas C Jacobson, PhD
  role: Principal Investigator
  affiliation: Dartmouth-Hitchcock Medical Center
  last name: Nicholas C Jacobson, PhD
  phone: +1(603)-646-7015
  email: nicholas.c.jacobson@dartmouth.edu
  last name: Sukanya Bhattacharya
  phone: 603-646-6306
  phone ext: 66306
  email: sukanya.bhattacharya.24@dartmouth.edu
  responsible party type: Principal Investigator
  investigator affiliation: Dartmouth-Hitchcock Medical Center
  investigator full name: Nicholas C. Jacobson
  investigator title: Dr. Nicholas Jacobson
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Feeding and Eating Disorders
  sharing ipd: No