<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/NCT04455646</url>
  </required_header>
  <id_info>
    <org_study_id>101</org_study_id>
    <nct_id>NCT04455646</nct_id>
  </id_info>
  <brief_title>Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)</brief_title>
  <official_title>Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brainsway</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brainsway</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A naturalistic study design, in which dTMS patients will be randomized to get a free add-on&#xD;
      CBT treatment. The dTMS procedure will include treatment as usual, and participants will use&#xD;
      the app from post randomization (Pre-treatment is defined as measures from the first three&#xD;
      days of treatment) to the end of dTMS treatment (Post-treatment which is defined as measures&#xD;
      from after twenty TMS sessions over a minimum of four weeks), and for an additional three&#xD;
      months of FU (FU).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be recruited from those attending dTMS clinics around the world&#xD;
      (i.e.,naturalistic study design), and consenting individuals (in person consent done in the&#xD;
      clinic on paper) will be given a random user code. This code will be specific for their&#xD;
      version of the app, and the only link between their signature and the code will remain at the&#xD;
      site for auditing purposes. Participants will undergo treatment as usual of dTMS and will use&#xD;
      GGDE twice a day. Participants will be asked to complete demographic and clinical&#xD;
      questionnaires via the GGDE app, and relevant clinical questionnaires will be re-administered&#xD;
      following treatment and during FU. The initial and all following dTMS sessions will involve&#xD;
      patients going through the stimulation procedure (The operator will record stimulation&#xD;
      variables such as individual patient's intensity of stimulation and coil location into GGDE)&#xD;
      followed by 5 min of GGDE use. The patient will indicate which statements (in that session)&#xD;
      were most relevant and challenging to them, which will be followed by a pre-prepared&#xD;
      psycho-education paragraph about the specific maladaptive belief addressed by the app that&#xD;
      day. The patient will then be prompted to use the app one more time at home during the same&#xD;
      day. Patient will continue similar use during FU, with two GGDE usage each day. The&#xD;
      naturalistic design will allow the accumulation of large quantities of data in a short period&#xD;
      of time, aiming to optimize GGDE using machine learning. Importantly, GGDE will allow the&#xD;
      random allocation of users to different GGDE modules of the app (i.e., similar app versions&#xD;
      with changes in specific parameters related to different depressive traits). One out of the&#xD;
      ten modules used in this trial will include neutral (placebo) stimuli requiring the user to&#xD;
      respond to plus/minus signs rather than MDD relevant statements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 26, 2019</start_date>
  <completion_date type="Anticipated">August 26, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 26, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Health Questionnaire (PHQ)</measure>
    <time_frame>1 year</time_frame>
    <description>The change from Pre- to Post-treatment in the Patient Health Questionnaire (PHQ) scores from baseline to endpoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Patient Health Questionnaire (PHQ)</measure>
    <time_frame>1 year</time_frame>
    <description>Response rate (50% reduction from Pre-treatment of the PHQ score), where the rate refers to the percentage of patients in response at Post-treatment.&#xD;
Remission rate (PHQ&lt;5; [1]), where the rate refers to the percentage of patients in remission at Post-treatment,&#xD;
Response rate, Remission rate, and the change from Pre-treatment to FU in the PHQ score.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">540</enrollment>
  <condition>Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT-based, mobile-delivered, intervention platform</intervention_name>
    <description>App of this platform have been shown to be associated with reduced psychopathology symptoms,including depressive symptoms, following treatment (i.e., relapse prevention). GGDE, which was specifically designed to address MDD related maladaptive beliefs and symptoms,includes different CBT-based intervention modules (nine active and one sham), as well as means for data collection and response monitoring. The active treatment modules will differ in the proportion of adaptive vs. maladaptive statements and the emphasis on particular content (e.g loneliness vs. hopelessness).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The intention is to enroll at least 540 patients diagnosed with MDD who were accepted into&#xD;
        dTMS treatment for depression. The patients will be of all racial, ethnic and gender&#xD;
        categories. The course of illness histories will be based upon patient reporting through&#xD;
        the GGDE app. Patients who are unlikely to show response based on the literature to date&#xD;
        (presence of psychosis, co-morbid and prominent anxiety disorder or substance abuse,&#xD;
        personality disorder or dysthymia) will not be asked to participate in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult outpatients accepted to treatment as usual dTMS with a Primary DSM-V diagnosis&#xD;
             of Major Depression, single or recurrent episode&#xD;
&#xD;
          -  Capable and willing to provide informed consent&#xD;
&#xD;
          -  In a possession of a Smartphone capable of running the GGDE app.&#xD;
&#xD;
          -  Able to adhere to the treatment schedule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Investigators, site personnel directly affiliated with this study, and their immediate&#xD;
        families (immediate family is defined as a spouse, parent, child or sibling, whether by&#xD;
        birth or legal adoption).&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Aron Tendler, MD</last_name>
    <phone>(561) 333-8884</phone>
    <email>aron.tendler@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amit Ezra, MA</last_name>
    <phone>+972503103134</phone>
    <phone_ext>+972503103134</phone_ext>
    <email>amite@brainsway.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kadima Neuropsychiatry</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Feifel, MD</last_name>
      <phone>858-412-4130</phone>
      <email>dfeifel@kadimanp.com</email>
    </contact>
    <investigator>
      <last_name>David Feifel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Advanced Mental Health Care Inc. - Juno Beach</name>
      <address>
        <city>Juno Beach</city>
        <state>Florida</state>
        <zip>33408</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elyssa Sisko</last_name>
      <phone>561-267-8876</phone>
      <email>elyssasisko@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Aron Tendler, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Advanced Mental Health Care Inc. - Palm Beach</name>
      <address>
        <city>Palm Beach</city>
        <state>Florida</state>
        <zip>33480</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elyssa Sisko</last_name>
      <phone>561-333-8884</phone>
    </contact>
    <contact_backup>
      <phone>561-386-1600</phone>
    </contact_backup>
    <investigator>
      <last_name>Aron Tendler</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Advanced Mental Health Care Inc. - Royal Palm Beach</name>
      <address>
        <city>Royal Palm Beach</city>
        <state>Florida</state>
        <zip>33411</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elyssa Sisko</last_name>
      <phone>561-267-8876</phone>
      <email>elyssasisko@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Aron Tendler, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Annapolis</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hanita Chhabra, MD</last_name>
      <phone>443-837-9645</phone>
      <email>sfox@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Columbia</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Misty Borst, MD</last_name>
      <phone>443-718-5206</phone>
      <email>mdraayer@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Frederick</name>
      <address>
        <city>Frederick</city>
        <state>Maryland</state>
        <zip>21701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joshua Sussal, MD</last_name>
      <phone>240-651-6824</phone>
      <email>dslim@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Glen Burnie</name>
      <address>
        <city>Glen Burnie</city>
        <state>Maryland</state>
        <zip>21061</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hanita Chhabra, MD</last_name>
      <phone>443-577-3703</phone>
      <email>kkapoor@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Greenbelt</name>
      <address>
        <city>Greenbelt</city>
        <state>Maryland</state>
        <zip>20770</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joshua Sussal, MD</last_name>
      <phone>240-542-0186</phone>
      <email>jkelley@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Kensington</name>
      <address>
        <city>Kensington</city>
        <state>Maryland</state>
        <zip>20895</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Geoffrey Grammer, MD</last_name>
      <phone>855-940-4867</phone>
      <email>bthompson@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Olney</name>
      <address>
        <city>Olney</city>
        <state>Maryland</state>
        <zip>20832</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joshua Sussal, MD</last_name>
      <phone>301-476-0391</phone>
      <email>pdasilva@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Rockville</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Geoffrey Grammer, MD</last_name>
      <phone>855-940-4867</phone>
      <email>jliu@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - O'Fallon</name>
      <address>
        <city>O'Fallon</city>
        <state>Missouri</state>
        <zip>63368</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Howard Ilivicky, MD</last_name>
      <phone>314-497-9657</phone>
      <email>pfowler@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Tesson Ferry</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steven Harvey, MD</last_name>
      <phone>314-748-0091</phone>
      <email>pfowler@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Creve Coeur</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Rifkin, MD</last_name>
      <phone>314-720-8561</phone>
      <email>pfowler@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Hernandez, MD</last_name>
      <phone>919-951-0271</phone>
      <email>sarnold@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Greensboro</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27410</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keshavpal Reddy, MD</last_name>
      <phone>336-808-0986</phone>
      <email>wsellars@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Matthews</name>
      <address>
        <city>Matthews</city>
        <state>North Carolina</state>
        <zip>28105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Darlene Ifill-Taylor, MD</last_name>
      <phone>704-321-8252</phone>
      <email>cwilson@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Raleigh</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kellie Tolin, MD</last_name>
      <phone>984-789-4739</phone>
      <email>mirvin@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook - Glen Allen</name>
      <address>
        <city>Glen Allen</city>
        <state>Virginia</state>
        <zip>23059</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>William Sauvé, MD</last_name>
      <phone>804-980-7520</phone>
      <email>hauerbach@greenbrooktms.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Greenbrook TMS NeuroHealth Centers</name>
      <address>
        <city>McLean</city>
        <state>Virginia</state>
        <zip>22102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Oleksik</last_name>
      <phone>703-356-1568</phone>
      <email>joleksik@greenbrooktms.com</email>
    </contact>
    <contact_backup>
      <last_name>Kirsten Burke</last_name>
      <phone>703-356-1568</phone>
    </contact_backup>
    <investigator>
      <last_name>Geoffrey Grammer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Greenbook - Newport News</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>William Sauvé, MD</last_name>
      <phone>757-320-0224</phone>
      <email>rrose@greenbrooktms.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</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>Depression</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>


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/NCT04455646
org study id: 101
nct id: NCT04455646
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
A naturalistic study design, in which dTMS patients will be randomized to get a free add-on
      CBT treatment. The dTMS procedure will include treatment as usual, and participants will use
      the app from post randomization (Pre-treatment is defined as measures from the first three
      days of treatment) to the end of dTMS treatment (Post-treatment which is defined as measures
      from after twenty TMS sessions over a minimum of four weeks), and for an additional three
      months of FU (FU).
Participants will be recruited from those attending dTMS clinics around the world
      (i.e.,naturalistic study design), and consenting individuals (in person consent done in the
      clinic on paper) will be given a random user code. This code will be specific for their
      version of the app, and the only link between their signature and the code will remain at the
      site for auditing purposes. Participants will undergo treatment as usual of dTMS and will use
      GGDE twice a day. Participants will be asked to complete demographic and clinical
      questionnaires via the GGDE app, and relevant clinical questionnaires will be re-administered
      following treatment and during FU. The initial and all following dTMS sessions will involve
      patients going through the stimulation procedure (The operator will record stimulation
      variables such as individual patient's intensity of stimulation and coil location into GGDE)
      followed by 5 min of GGDE use. The patient will indicate which statements (in that session)
      were most relevant and challenging to them, which will be followed by a pre-prepared
      psycho-education paragraph about the specific maladaptive belief addressed by the app that
      day. The patient will then be prompted to use the app one more time at home during the same
      day. Patient will continue similar use during FU, with two GGDE usage each day. The
      naturalistic design will allow the accumulation of large quantities of data in a short period
      of time, aiming to optimize GGDE using machine learning. Importantly, GGDE will allow the
      random allocation of users to different GGDE modules of the app (i.e., similar app versions
      with changes in specific parameters related to different depressive traits). One out of the
      ten modules used in this trial will include neutral (placebo) stimuli requiring the user to
      respond to plus/minus signs rather than MDD relevant statements.
observational model: Cohort
time perspective: Retrospective
measure: Patient Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Patient Health Questionnaire (PHQ) Health Questionnaire (PHQ)
time frame: 1 year
description: The change from Pre- to Post-treatment in the Patient Health Questionnaire (PHQ) scores from baseline to endpoint.
measure: Patient Patient Health Questionnaire (PHQ)
time frame: 1 year
description: Response rate (50% reduction from Pre-treatment of the PHQ score), where the rate refers to the percentage of patients in response at Post-treatment.
Remission rate (PHQ<5; [1]), where the rate refers to the percentage of patients in remission at Post-treatment,
Response rate, Remission rate, and the change from Pre-treatment to FU in the PHQ score.
intervention type: Behavioral
intervention name: CBT-based, mobile-delivered, intervention platform
description: App of this platform have been shown to be associated with reduced psychopathology symptoms,including depressive symptoms, following treatment (i.e., relapse prevention). GGDE, which was specifically designed to address MDD related maladaptive beliefs and symptoms,includes different CBT-based intervention modules (nine active and one sham), as well as means for data collection and response monitoring. The active treatment modules will differ in the proportion of adaptive vs. maladaptive statements and the emphasis on particular content (e.g loneliness vs. hopelessness).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: 68 Years
healthy volunteers: No
last name: Aron Tendler, MD
phone: (561) 333-8884
email: aron.tendler@gmail.com
last name: Amit Ezra, MA
phone: +972503103134
phone ext: +972503103134
email: amite@brainsway.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder, Major
sharing ipd: No