<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/NCT03011619</url>
  </required_header>
  <id_info>
    <org_study_id>16-01404</org_study_id>
    <nct_id>NCT03011619</nct_id>
  </id_info>
  <brief_title>Brief CBT for the Treatment of Depression During Inpatient Hospitalization</brief_title>
  <official_title>Brief CBT for the Treatment of Depression During Inpatient Hospitalization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Moderately to severely depressed subjects will be randomized to the &quot;Control Group,&quot; who will&#xD;
      receive care as usual, or the &quot;CBT Group,&quot; who will receive care as usual in addition to the&#xD;
      manualized course of Cognitive Behavioral Therapy (CBT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants assigned to the CBT condition will receive the usual standard of care during an&#xD;
      inpatient psychiatric hospitalization. This includes but is not limited to medication&#xD;
      management, group therapy, and individual therapy. If a patient is randomly assigned to the&#xD;
      enhanced CBT group, manualized CBT, including a sequence of sessions that builds upon prior&#xD;
      sessions and planned exercises, including worksheets and journal entries.The training M.D.,&#xD;
      who is a treating physician on HCC-10, will also intermittently and randomly observe the CBT&#xD;
      sessions to ensure the manual properly is being followed. Although the control condition may&#xD;
      contain elements of CBT as per the clinician completing the therapy, it is not manualized,&#xD;
      does not include specific exercises to be completed between sessions, and is not a course&#xD;
      that builds upon skills from the previous day, as in the CBT condition. Participants assigned&#xD;
      to the control condition will receive the usual standard of care during an inpatient&#xD;
      psychiatric hospitalization. This includes but is not limited to medication management, group&#xD;
      therapy, and individual therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI left institution&#xD;
  </why_stopped>
  <start_date type="Actual">April 6, 2017</start_date>
  <completion_date type="Actual">April 5, 2018</completion_date>
  <primary_completion_date type="Actual">April 5, 2018</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>Montgomery-Ashberg Depression Scale (MADRS)</measure>
    <time_frame>15 Minutes</time_frame>
    <description>A ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. The ten questions rate the severity of symptoms on scale of 0 (not present), 2 (mild), 4 (moderate), and 6 (severe). It is designed to be sensitive to change, so is often the scale of choice when interventions, such as psychotherapies, electroconvulsive therapy, or drug trials, are being studied.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hamilton Rating Scale for Depression (HAM-D)</measure>
    <time_frame>20 Minutes</time_frame>
    <description>Clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression Severity Scale (CGI-S)</measure>
    <time_frame>20 Minutes</time_frame>
    <description>Single-item rating scale of the clinician's assessment of the global severity of depressive symptoms in relation to the clinician's total experience with depressed patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Control Condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>usual standard of care during an inpatient psychiatric hospitalization; medication management, group therapy, and individual therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBT Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If a patient is randomly assigned to the enhanced CBT group, they will participate in manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Standard of Care</intervention_name>
    <description>medication management, group therapy, and individual therapy.</description>
    <arm_group_label>CBT Condition</arm_group_label>
    <arm_group_label>Control Condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy Condition (CBT)</intervention_name>
    <description>CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.</description>
    <arm_group_label>CBT Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with depression according to Diagnostic and Statistical Manual of Mental&#xD;
             Disorders, Fifth Edition (DSM-V) criteria on initial assessment on the unit.&#xD;
&#xD;
          -  Demonstrates at least moderate degree of depressive symptoms on MADRS, HAM-D, and&#xD;
             CGI-S.&#xD;
&#xD;
          -  Provides written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A mental illness other than depression that is the primary cause of treatment, as&#xD;
             determined by the Principal Investigator.&#xD;
&#xD;
          -  A cognitive or neurologic disorder that inhibits ability to engage in CBT.&#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>Jacqueline Sergie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>March 22, 2019</last_update_submitted>
  <last_update_submitted_qc>March 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Cognitive Behavioral Therapy (CBT)</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>
  </condition_browse>
  <!-- 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/NCT03011619
org study id: 16-01404
nct id: NCT03011619
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Moderately to severely depressed subjects will be randomized to the "Control Group," who will
      receive care as usual, or the "CBT Group," who will receive care as usual in addition to the
      manualized course of Cognitive Behavioral Therapy (CBT).
Participants assigned to the CBT condition will receive the usual standard of care during an
      inpatient psychiatric hospitalization. This includes but is not limited to medication
      management, group therapy, and individual therapy. If a patient is randomly assigned to the
      enhanced CBT group, manualized CBT, including a sequence of sessions that builds upon prior
      sessions and planned exercises, including worksheets and journal entries.The training M.D.,
      who is a treating physician on HCC-10, will also intermittently and randomly observe the CBT
      sessions to ensure the manual properly is being followed. Although the control condition may
      contain elements of CBT as per the clinician completing the therapy, it is not manualized,
      does not include specific exercises to be completed between sessions, and is not a course
      that builds upon skills from the previous day, as in the CBT condition. Participants assigned
      to the control condition will receive the usual standard of care during an inpatient
      psychiatric hospitalization. This includes but is not limited to medication management, group
      therapy, and individual therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Montgomery-Ashberg Depression Scale (MADRS)
time frame: 15 Minutes
description: A ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. The ten questions rate the severity of symptoms on scale of 0 (not present), 2 (mild), 4 (moderate), and 6 (severe). It is designed to be sensitive to change, so is often the scale of choice when interventions, such as psychotherapies, electroconvulsive therapy, or drug trials, are being studied.
measure: Hamilton Rating Scale for Depression (HAM-D)
time frame: 20 Minutes
description: Clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness.
measure: Clinical Global Impression Severity Scale (CGI-S)
time frame: 20 Minutes
description: Single-item rating scale of the clinician's assessment of the global severity of depressive symptoms in relation to the clinician's total experience with depressed patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
arm group label: Control Condition
arm group type: Active Comparator
description: usual standard of care during an inpatient psychiatric hospitalization; medication management, group therapy, and individual therapy.
arm group label: CBT Condition
arm group type: Experimental
description: If a patient is randomly assigned to the enhanced CBT group, they will participate in manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.
intervention type: Behavioral
intervention name: Usual Standard of Care
description: medication management, group therapy, and individual therapy.
arm group label: CBT Condition
arm group label: Control Condition
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy Condition (CBT)
description: CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.
arm group label: CBT Condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jacqueline Sergie, MD
role: Principal Investigator
affiliation: NYU School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder