<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/NCT01692067</url>
  </required_header>
  <id_info>
    <org_study_id>PT075819</org_study_id>
    <secondary_id>GRANT00341283 (USAMRMC)</secondary_id>
    <secondary_id>DHI08-136 (DVA)</secondary_id>
    <nct_id>NCT01692067</nct_id>
  </id_info>
  <brief_title>Deployment Health in Regular Military Women</brief_title>
  <acronym>DHRMS</acronym>
  <official_title>Combat, Sexual Assault and Post-Traumatic Stress in OIF/OEF Military Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Iowa City Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>US Department of Veterans Affairs</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Iowa City Veterans Affairs Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine potential risk factors for physical and sexual&#xD;
      assault in regular military women (as opposed to Reserve and National Guard). In addition,&#xD;
      this study seeks to determine associations between service women's violence exposures and:&#xD;
      current physical and mental health status (e.g. PTSD), and access to and use of DoD, DVA and&#xD;
      civilian healthcare.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The proposed study of Regular Military service women builds on and extends a&#xD;
      funded VA HSR&amp;D grant currently investigating similar objectives in Reserves and National&#xD;
      Guard (R/NG) service women. This proposed study addresses the radically changing DoD and DVA&#xD;
      health care delivery needs of two priority populations: women exposed to combat, and women&#xD;
      sexually assaulted during military. There is a limited understanding of the complex&#xD;
      relationship between these traumatic exposures and women's health outcomes, such as&#xD;
      post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI) and with their&#xD;
      subsequent health service use or barriers to care.&#xD;
&#xD;
      Objectives: The objectives are: 1) To identify and describe organizational, situational, and&#xD;
      individual risk factors for physical and sexual assault (i.e., victimization) in women who&#xD;
      have served or are currently serving in the Regular Military in Operation Enduring Freedom&#xD;
      and Operation Iraqi Freedom (OEF/OIF) by deployment status (those who are deployed to combat&#xD;
      related regions once, those deployed more than once, those serving in non-combat related&#xD;
      areas outside of the continental United States (US), or those serving within the continental&#xD;
      US. 2) To determine associations between PTSD, TBI, and physical and sexual assault during&#xD;
      OEF/OIF with current physical and mental health status and health risk behaviors by&#xD;
      deployment status. 3) To identify current internal and external barriers to DoD, DVA, and&#xD;
      civilian health services in relationship to women's deployment and victimization status and&#xD;
      the association between PTSD and TBI; 4) To identify and describe differences between Regular&#xD;
      Military and R/NG populations for each of these objectives.&#xD;
&#xD;
      Methods: We propose a cross sectional study design with two sequential phases. Phase 1 would&#xD;
      include focus groups to refine the current study interview specific to Regular Military&#xD;
      populations. Phase 2 would involve the identification and successful interviewing of 669&#xD;
      Regular Military service women, using random sampling with stratification by deployment&#xD;
      status, state of service accession, and service branch. Building on our current study, women&#xD;
      will be selected from five states: Iowa, Illinois, Kansas, Missouri, and Nebraska. Potential&#xD;
      study participants will be mailed an information summary and asked to take part in a study&#xD;
      assessing the deployment health of military women. 1058 women will be contacted to obtain the&#xD;
      target of 669 completed interviews. Consenting participants (167 per deployment group) will&#xD;
      complete a telephone interview that assesses socio-demographic variables, trauma exposures,&#xD;
      health history, current health status, military environmental factors (organizational and&#xD;
      situational factors), military and DVA health care and barriers to this care, and self&#xD;
      reported service use. Descriptive analysis and multiple logistic regression analysis will be&#xD;
      used.&#xD;
&#xD;
      Implications: It is unclear if the needs of military women are met by current&#xD;
      combat-associated PTSD treatments originally based on male populations. It is anticipated&#xD;
      that our findings will improve understanding of the health risks and outcomes of deployed&#xD;
      Regular Military service women in contrast to women serving in the R/NG (with PTSD and TBI as&#xD;
      key outcome variables). Our results consequently will have implications for DoD and DVA&#xD;
      evidence based interventions for both primary prevention and care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Organizational, situational, and individual risk factors for physical and sexual assault in women who have or currently serving in active duty Regular Military in OIF/OEF by deployment status.</measure>
    <time_frame>Months 28-42 of grant</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Traumatic brain injury</measure>
    <time_frame>Months 28-42 of grant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Current internal (e.g. PTSD) and external barriers (e.g. access to care factors)to health services</measure>
    <time_frame>Months 28-42 of grant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification and description of differences between Regular Military and Reserve/National Guard service women for each of these aims (building on currently funded grant).</measure>
    <time_frame>Months 28-42 of grant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD</measure>
    <time_frame>Months 28-42 of Grant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Current medical health, including reproductive health</measure>
    <time_frame>Months 28-42 of grant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deployment factors associated with risk of violence/health</measure>
    <time_frame>Months 28-42 of grant</time_frame>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">871</enrollment>
  <condition>Military Physical and Sexual Trauma</condition>
  <condition>Combat Trauma</condition>
  <condition>PTSD</condition>
  <condition>TBI</condition>
  <arm_group>
    <arm_group_label>D0</arm_group_label>
    <description>Not deployed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D1</arm_group_label>
    <description>Deployed to combat-related regions once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D2</arm_group_label>
    <description>Deployed to combat related regions more than once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D3</arm_group_label>
    <description>Deployed outside of the continental US but not to combat related regions</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women and Men who have or are currently serving in the USA regular military.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Focus Group:&#xD;
&#xD;
               -  Men or women who have or are currently active duty regular military (RM) of&#xD;
                  OIF/OEF service eras (10/7/01- present)&#xD;
&#xD;
          -  Interview phase:&#xD;
&#xD;
               -  Women, who have or are currently serving active duty RM during OIF/OEF service&#xD;
                  eras&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Focus Group:&#xD;
&#xD;
               -  Disabilities that render incapable of hearing&#xD;
&#xD;
               -  Comprehending&#xD;
&#xD;
               -  Communicating in a group or inhibit travel to focus group&#xD;
&#xD;
          -  Interview phase:&#xD;
&#xD;
               -  Disabilities that render incapable of hearing&#xD;
&#xD;
               -  Comprehending&#xD;
&#xD;
               -  Communicating independently with interviewers by telephone&#xD;
&#xD;
               -  Not having telephone and unable to access a nearby VA or other possible resource&#xD;
                  to contact toll free number.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne G Sadler, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>US Department of Veterans Affairs</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anne G. Sadler, Ph.D.; VAMC</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa City VAMC</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 28, 2011</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>July 18, 2019</last_update_submitted>
  <last_update_submitted_qc>July 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Iowa City Veterans Affairs Medical Center</investigator_affiliation>
    <investigator_full_name>Anne G SAdler</investigator_full_name>
    <investigator_title>CADRE Core Investigator</investigator_title>
  </responsible_party>
  <keyword>Rape</keyword>
  <keyword>Women</keyword>
  <keyword>Military</keyword>
  <keyword>Veterans</keyword>
  <keyword>Post-traumatic Stress Disorder</keyword>
  <keyword>Traumatic Brain Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Sexual Trauma</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/NCT01692067
org study id: PT075819
secondary id: GRANT00341283 (USAMRMC)
secondary id: DHI08-136 (DVA)
nct id: NCT01692067
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine potential risk factors for physical and sexual
      assault in regular military women (as opposed to Reserve and National Guard). In addition,
      this study seeks to determine associations between service women's violence exposures and:
      current physical and mental health status (e.g. PTSD), and access to and use of DoD, DVA and
      civilian healthcare.
Background: The proposed study of Regular Military service women builds on and extends a
      funded VA HSR&D grant currently investigating similar objectives in Reserves and National
      Guard (R/NG) service women. This proposed study addresses the radically changing DoD and DVA
      health care delivery needs of two priority populations: women exposed to combat, and women
      sexually assaulted during military. There is a limited understanding of the complex
      relationship between these traumatic exposures and women's health outcomes, such as
      post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI) and with their
      subsequent health service use or barriers to care.

      Objectives: The objectives are: 1) To identify and describe organizational, situational, and
      individual risk factors for physical and sexual assault (i.e., victimization) in women who
      have served or are currently serving in the Regular Military in Operation Enduring Freedom
      and Operation Iraqi Freedom (OEF/OIF) by deployment status (those who are deployed to combat
      related regions once, those deployed more than once, those serving in non-combat related
      areas outside of the continental United States (US), or those serving within the continental
      US. 2) To determine associations between PTSD, TBI, and physical and sexual assault during
      OEF/OIF with current physical and mental health status and health risk behaviors by
      deployment status. 3) To identify current internal and external barriers to DoD, DVA, and
      civilian health services in relationship to women's deployment and victimization status and
      the association between PTSD and TBI; 4) To identify and describe differences between Regular
      Military and R/NG populations for each of these objectives.

      Methods: We propose a cross sectional study design with two sequential phases. Phase 1 would
      include focus groups to refine the current study interview specific to Regular Military
      populations. Phase 2 would involve the identification and successful interviewing of 669
      Regular Military service women, using random sampling with stratification by deployment
      status, state of service accession, and service branch. Building on our current study, women
      will be selected from five states: Iowa, Illinois, Kansas, Missouri, and Nebraska. Potential
      study participants will be mailed an information summary and asked to take part in a study
      assessing the deployment health of military women. 1058 women will be contacted to obtain the
      target of 669 completed interviews. Consenting participants (167 per deployment group) will
      complete a telephone interview that assesses socio-demographic variables, trauma exposures,
      health history, current health status, military environmental factors (organizational and
      situational factors), military and DVA health care and barriers to this care, and self
      reported service use. Descriptive analysis and multiple logistic regression analysis will be
      used.

      Implications: It is unclear if the needs of military women are met by current
      combat-associated PTSD treatments originally based on male populations. It is anticipated
      that our findings will improve understanding of the health risks and outcomes of deployed
      Regular Military service women in contrast to women serving in the R/NG (with PTSD and TBI as
      key outcome variables). Our results consequently will have implications for DoD and DVA
      evidence based interventions for both primary prevention and care.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Organizational, situational, and individual risk factors for physical and sexual assault in women who have or currently serving in active duty Regular Military in OIF/OEF by deployment status.
time frame: Months 28-42 of grant
measure: Traumatic brain injury
time frame: Months 28-42 of grant
measure: Current internal (e.g. PTSD) and external barriers (e.g. access to care factors)to health services
time frame: Months 28-42 of grant
measure: Identification and description of differences between Regular Military and Reserve/National Guard service women for each of these aims (building on currently funded grant).
time frame: Months 28-42 of grant
measure: PTSD
time frame: Months 28-42 of Grant
measure: Current medical health, including reproductive health
time frame: Months 28-42 of grant
measure: Deployment factors associated with risk of violence/health
time frame: Months 28-42 of grant
arm group label: D0
description: Not deployed
arm group label: D1
description: Deployed to combat-related regions once
arm group label: D2
description: Deployed to combat related regions more than once
arm group label: D3
description: Deployed outside of the continental US but not to combat related regions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anne G Sadler, Ph.D.
role: Principal Investigator
affiliation: US Department of Veterans Affairs
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Iowa City Veterans Affairs Medical Center
investigator full name: Anne G SAdler
investigator title: CADRE Core Investigator
mesh term: Wounds and Injuries
mesh term: Sexual Trauma