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/NCT05988619</url>
    </required_header>
    <id_info>
      <org_study_id>19000581</org_study_id>
      <nct_id>NCT05988619</nct_id>
    </id_info>
    <brief_title>iCBT With TMS in Patients With MDD</brief_title>
    <official_title>Combined Internet-Based Cognitive Behavioral Therapy With Transcranial Magnetic Stimulation for Patients With Major Depressive Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Los Angeles</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, Los Angeles</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Major Depressive Disorder (MDD) is a common mental health diagnosis. While there are many&#xD;
        approaches to the treatment of MDD, current treatments of MDD often do not substantially&#xD;
        reduce depressive symptoms among those in need of care. Prior research suggests that&#xD;
        combining cognitive-behavioral therapy (CBT) and psychopharmacology can produce optimal&#xD;
        treatment outcomes compared to the use of either treatment individually. Transcranial&#xD;
        Magnetic Stimulation (TMS) is one promising brain stimulation approach used to treat MDD,&#xD;
        especially among patients with treatment-resistant symptoms. Like psychopharmacological&#xD;
        interventions, TMS may produce optimal treatment outcomes when paired with CBT. However,&#xD;
        standard TMS protocols are time-intensive, typically requiring daily doctor visits for one&#xD;
        hour of six to eight weeks. Therefore, an internet-delivered CBT protocol may augment the&#xD;
        effects of TMS without substantially increasing patient burden. To that end, the present&#xD;
        study assesses if a combined TMS and internet-delivered CBT protocol may produce superior&#xD;
        treatment outcomes compared with TMS alone.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 21, 2021</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 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 (Care Provider)</masking>
      <masking_description>Care providers administering the TMS treatment are blinded and do not know whether the participant has been randomized to receive iCBT or educational content as a supplement to the TMS treatment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Depression Symptoms</measure>
      <time_frame>Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up</time_frame>
      <description>Change in depression symptoms as measured by the Hamilton Depression Rating Scale (HAM-D), Dimensional Anhedonia Rating Scale (DARS), Temporal Experience of Pleasure Scale (TEPS), Inventory of Depressive Symptomatology (IDS), and Sheehan Disability Scale (SDS).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Major Depressive Disorder</condition>
    <arm_group>
      <arm_group_label>iCBT and TMS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>All participants complete six weeks of TMS treatment (five days per week) within the UCLA TMS Clinic. Participants in this condition additionally access iCBT materials and attend a weekly session for 30 minutes with a trained mental health coach to discuss iCBT content.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Psychoeducation and TMS</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>All participants complete six weeks of TMS treatment (five days per week) within the UCLA TMS Clinic. Participants in this condition additionally access educational materials about mental health and attend a weekly session for 30 minutes with a trained mental health coach to discuss educational content.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial Magnetic Stimulation</intervention_name>
      <description>TMS is a noninvasive method of brain stimulation administered by physicians in the UCLA TMS Clinical and Research Service. It is an FDA-approved treatment for Major Depressive Disorder.</description>
      <arm_group_label>Psychoeducation and TMS</arm_group_label>
      <arm_group_label>iCBT and TMS</arm_group_label>
      <other_name>TMS</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Internet-Based Cognitive Behavioral Therapy</intervention_name>
      <description>This Way Up is an internet-based cognitive behavioral therapy (iCBT) for depression and anxiety. Participants learn about depression and anxiety symptoms, as well as behavioral strategies for addressing these symptoms. Participants are provided with homework exercises designed to help them engage in these strategies regularly.</description>
      <arm_group_label>iCBT and TMS</arm_group_label>
      <other_name>iCBT</other_name>
      <other_name>This Way Up</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Psychoeducation</intervention_name>
      <description>Stories of the Mind is an educational program that is freely available through the Public Broadcast Service (PBS). Participants view video testimonials in which individuals describe their personal experiences across a variety of mental health concerns.</description>
      <arm_group_label>Psychoeducation and TMS</arm_group_label>
      <other_name>Stories of the Mind</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Subjects with Major Depressive Disorder who are receiving a full course of TMS treatment in&#xD;
          at the UCLA TMS Clinic. Eligibility is determined by TMS physicians who are&#xD;
          co-investigators on this study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Any indications of metal implants, pregnancy, psychosis, autism spectrum disorders, complex&#xD;
          regional pain syndromes, substance use dependence and comorbidities that would interfere&#xD;
          with treatment response. The criteria are assessed using MINI interview and Hamilton&#xD;
          Depression scale conducted by trained and certified interviewers. Participants may not&#xD;
          participate if they are currently completing CBT outside of 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_contact>
      <last_name>Benjamin M Rosenberg, PhD</last_name>
      <phone>310-825-7471</phone>
      <email>benrosenberg@g.ucla.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>UCLA TMS Clinical and Research Service</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90024</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrew F Leuchter, MD</last_name>
        <phone>310-825-7471</phone>
        <email>UCLATMS@mednet.ucla.edu</email>
      </contact>
      <investigator>
        <last_name>Andrew F Leuchter, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Michelle G Craske, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Benjamin M Rosenberg, 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 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
      <investigator_full_name>Ben Rosenberg</investigator_full_name>
      <investigator_title>Postdoctoral Fellow</investigator_title>
    </responsible_party>
    <keyword>Depression</keyword>
    <keyword>TMS</keyword>
    <keyword>Brain Stimulation</keyword>
    <keyword>Internet-Based CBT</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depressive Disorder</mesh_term>
      <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>
  
  
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/NCT05988619
  org study id: 19000581
  nct id: NCT05988619
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  Major Depressive Disorder (MDD) is a common mental health diagnosis. While there are many
        approaches to the treatment of MDD, current treatments of MDD often do not substantially
        reduce depressive symptoms among those in need of care. Prior research suggests that
        combining cognitive-behavioral therapy (CBT) and psychopharmacology can produce optimal
        treatment outcomes compared to the use of either treatment individually. Transcranial
        Magnetic Stimulation (TMS) is one promising brain stimulation approach used to treat MDD,
        especially among patients with treatment-resistant symptoms. Like psychopharmacological
        interventions, TMS may produce optimal treatment outcomes when paired with CBT. However,
        standard TMS protocols are time-intensive, typically requiring daily doctor visits for one
        hour of six to eight weeks. Therefore, an internet-delivered CBT protocol may augment the
        effects of TMS without substantially increasing patient burden. To that end, the present
        study assesses if a combined TMS and internet-delivered CBT protocol may produce superior
        treatment outcomes compared with TMS alone.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Care Provider)
  masking description: Care providers administering the TMS treatment are blinded and do not know whether the participant has been randomized to receive iCBT or educational content as a supplement to the TMS treatment.
  measure: Change in Depression Symptoms
  time frame: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
  description: Change in depression symptoms as measured by the Hamilton Depression Rating Scale (HAM-D), Dimensional Anhedonia Rating Scale (DARS), Temporal Experience of Pleasure Scale (TEPS), Inventory of Depressive Symptomatology (IDS), and Sheehan Disability Scale (SDS).
  arm group label: iCBT and TMS
  arm group type: Active Comparator
  description: All participants complete six weeks of TMS treatment (five days per week) within the UCLA TMS Clinic. Participants in this condition additionally access iCBT materials and attend a weekly session for 30 minutes with a trained mental health coach to discuss iCBT content.
  arm group label: Psychoeducation and TMS
  arm group type: Placebo Comparator
  description: All participants complete six weeks of TMS treatment (five days per week) within the UCLA TMS Clinic. Participants in this condition additionally access educational materials about mental health and attend a weekly session for 30 minutes with a trained mental health coach to discuss educational content.
  intervention type: Device
  intervention name: Transcranial Magnetic Stimulation
  description: TMS is a noninvasive method of brain stimulation administered by physicians in the UCLA TMS Clinical and Research Service. It is an FDA-approved treatment for Major Depressive Disorder.
  arm group label: Psychoeducation and TMS
  arm group label: iCBT and TMS
  other name: TMS
  intervention type: Behavioral
  intervention name: Internet-Based Cognitive Behavioral Therapy
  description: This Way Up is an internet-based cognitive behavioral therapy (iCBT) for depression and anxiety. Participants learn about depression and anxiety symptoms, as well as behavioral strategies for addressing these symptoms. Participants are provided with homework exercises designed to help them engage in these strategies regularly.
  arm group label: iCBT and TMS
  other name: iCBT
  other name: This Way Up
  intervention type: Behavioral
  intervention name: Psychoeducation
  description: Stories of the Mind is an educational program that is freely available through the Public Broadcast Service (PBS). Participants view video testimonials in which individuals describe their personal experiences across a variety of mental health concerns.
  arm group label: Psychoeducation and TMS
  other name: Stories of the Mind
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Benjamin M Rosenberg, PhD
  phone: 310-825-7471
  email: benrosenberg@g.ucla.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of California, Los Angeles
  investigator full name: Ben Rosenberg
  investigator title: Postdoctoral Fellow
  mesh term: Depressive Disorder
  mesh term: Depression
  mesh term: Depressive Disorder, Major
  sharing ipd: No