<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/NCT03803332</url>
  </required_header>
  <id_info>
    <org_study_id>1409015511</org_study_id>
    <secondary_id>W81XWH-16-R-BAA1</secondary_id>
    <nct_id>NCT03803332</nct_id>
  </id_info>
  <brief_title>A Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Due to Military Sexual Trauma (MST) in Male and Female Military Personnel</brief_title>
  <official_title>A Non-Inferiority Randomized Controlled Clinical Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Consequent to Military Sexual Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare two kinds of therapy for Posttraumatic Stress&#xD;
      Disorder (PTSD): exposure therapy (ET) and Interpersonal Psychotherapy (IPT). The results of&#xD;
      this study will allow us to see if IPT and ET are equally effective in treating PTSD due to&#xD;
      Military Sexual Trauma, with the long-term goal of making PTSD treatment effective for as&#xD;
      many people as possible.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 9, 2020</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">March 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>Difference in mean Clinician Administered PTSD Scale-5 (CAPS-5) score changes between the Exposure Therapy (ET) and Interpersonal Psychotherapy (IPT) treatment groups from baseline to post-treatment</measure>
    <time_frame>Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition</time_frame>
    <description>The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group</measure>
    <time_frame>Baseline, 11 weeks</time_frame>
    <description>The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group</measure>
    <time_frame>Baseline, 15 weeks</time_frame>
    <description>The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">208</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>Exposure Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive 10 90-minute exposure therapy sessions for PTSD following the treatment procedures as outlined in the standard Prolonged Exposure therapy manual.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interpersonal Psychotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure Therapy</intervention_name>
    <description>Psychotherapy including imaginal and in vivo exposure for PTSD.</description>
    <arm_group_label>Exposure Therapy</arm_group_label>
    <other_name>Prolonged Exposure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interpersonal Psychotherapy</intervention_name>
    <description>Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.</description>
    <arm_group_label>Interpersonal Psychotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Military Sexual Trauma (MST) survivors, with MST defined as actual or threatened&#xD;
             sexual violence, from Vietnam era to current Operation Iraqi Freedom/Operation&#xD;
             Enduring Freedom/Operation New Dawn&#xD;
&#xD;
          -  Diagnosed with PTSD consequent to MST, with a minimum CAPS score &gt; 40&#xD;
&#xD;
          -  Medically stable at time of study enrollment (for persons with chronic injuries and&#xD;
             that any disability present does not prevent attendance of weekly outpatient therapy&#xD;
             sessions)&#xD;
&#xD;
          -  Ability to provide informed consent and function at an intellectual level sufficient&#xD;
             to allow accurate completion of all assessment instruments&#xD;
&#xD;
          -  Stable on psychotropic medication for the prior 60 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar&#xD;
             disorder&#xD;
&#xD;
          -  Participation in a clinical trial or concurrent evidence-based treatment for&#xD;
             MST-related psychiatric conditions or PTSD during the previous 3 months&#xD;
&#xD;
          -  Current evidence of significant unstable medical illness or organic brain impairment&#xD;
             such that the patient could not attend sessions regularly or complete assessments&#xD;
&#xD;
          -  Patients who in the investigator's judgment pose a current homicidal or suicidal risk&#xD;
&#xD;
          -  Current or history of substance dependence in the past 90 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JoAnn Difede, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Olivia Baryluk, BS</last_name>
    <phone>212-821-0783</phone>
    <email>olb4002@med.cornell.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivia Baryluk, BS</last_name>
      <phone>212-821-0783</phone>
      <email>olb4002@med.cornell.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>October 11, 2022</last_update_submitted>
  <last_update_submitted_qc>October 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>Military Sexual Trauma</keyword>
  <keyword>exposure therapy</keyword>
  <keyword>interpersonal psychotherapy</keyword>
  <keyword>treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sexual Trauma</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/NCT03803332
org study id: 1409015511
secondary id: W81XWH-16-R-BAA1
nct id: NCT03803332
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare two kinds of therapy for Posttraumatic Stress
      Disorder (PTSD): exposure therapy (ET) and Interpersonal Psychotherapy (IPT). The results of
      this study will allow us to see if IPT and ET are equally effective in treating PTSD due to
      Military Sexual Trauma, with the long-term goal of making PTSD treatment effective for as
      many people as possible.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Difference in mean Clinician Administered PTSD Scale-5 (CAPS-5) score changes between the Exposure Therapy (ET) and Interpersonal Psychotherapy (IPT) treatment groups from baseline to post-treatment
time frame: Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition
description: The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
measure: Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group
time frame: Baseline, 11 weeks
description: The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
measure: Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group
time frame: Baseline, 15 weeks
description: The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
arm group label: Exposure Therapy
arm group type: Active Comparator
description: Participants receive 10 90-minute exposure therapy sessions for PTSD following the treatment procedures as outlined in the standard Prolonged Exposure therapy manual.
arm group label: Interpersonal Psychotherapy
arm group type: Active Comparator
description: Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life.
intervention type: Behavioral
intervention name: Exposure Therapy
description: Psychotherapy including imaginal and in vivo exposure for PTSD.
arm group label: Exposure Therapy
other name: Prolonged Exposure
intervention type: Behavioral
intervention name: Interpersonal Psychotherapy
description: Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.
arm group label: Interpersonal Psychotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: JoAnn Difede, PhD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: Olivia Baryluk, BS
phone: 212-821-0783
email: olb4002@med.cornell.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Sexual Trauma
sharing ipd: No