<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/NCT03303326</url>
  </required_header>
  <id_info>
    <org_study_id>064917B3E</org_study_id>
    <nct_id>NCT03303326</nct_id>
  </id_info>
  <brief_title>Arab American Women's Health Study</brief_title>
  <official_title>Arab American Women's Health Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Blue Cross Blue Shield of Michigan Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wayne State University</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>
      This study evaluates how Arab American women's cultural values and sexual health are related&#xD;
      to their physical and emotional health. The study will also examine whether engaging in a&#xD;
      sexual health interview affects women's physical and emotional health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sexuality is an important aspect of health, in part because emotional conflicts over&#xD;
      sexuality as well as unwanted sexual experiences can impact physical and psychological&#xD;
      health; yet no studies have examined sexual health among Arab American women in the U.S.&#xD;
      These women face the task of negotiating their heritage culture and the American culture in&#xD;
      which they reside. This may result in bicultural identity conflict for some women as they try&#xD;
      to negotiate these two identities, which may have implications for sexuality and sexual&#xD;
      health due to the two cultures' disparate views on sexuality. Confidential discussion of&#xD;
      these sensitive topics with a knowledgeable interviewer may yield beneficial effects.&#xD;
&#xD;
      The overall goal of the current study is to fill the gap in the literature on Arab American&#xD;
      sexual health by examining how sexual health is related to physical and psychological health.&#xD;
      This will be accomplished using both: a) correlational findings about sexual, physical, and&#xD;
      psychological health from information gathered through self-report questionnaires and a&#xD;
      60-minute women's health interview; and b) an experimental test of the effects of the women's&#xD;
      health interview on physical and psychological health. A sample of young adult Arab American&#xD;
      women will be assessed at baseline via questionnaires for various constructs (sexual&#xD;
      attitudes, cultural and religious identity, and physical and mental health), and then&#xD;
      randomized to either an immediate or delayed health interview, with a 5-week follow-up&#xD;
      reassessment.&#xD;
&#xD;
      It is hypothesized that lower sexual well-being, negative sexual self-schemas, and unwanted&#xD;
      sexual experiences will correlate with more somatic and psychological health symptoms and&#xD;
      lower satisfaction with life. It is also hypothesized that participants who have the&#xD;
      immediate interview will report greater reduction in somatic and psychological symptoms and a&#xD;
      greater willingness to discuss sexual health with medical providers compared to participants&#xD;
      who are not interviewed (i.e., have a delayed interview after follow-up assessment).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">May 24, 2018</completion_date>
  <primary_completion_date type="Actual">May 24, 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Health Questionnaire</measure>
    <time_frame>Change from baseline to 5-week follow-up</time_frame>
    <description>Physical symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brief Symptom Inventory</measure>
    <time_frame>Change from baseline to 5-week follow-up</time_frame>
    <description>Psychological symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Life Scale</measure>
    <time_frame>Change from baseline to 5-week follow-up</time_frame>
    <description>Satisfaction with life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Self-Schema Scale</measure>
    <time_frame>Change from baseline to 5-week follow-up</time_frame>
    <description>Sexual self-schemas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Self Disclosure Scale (Catania)</measure>
    <time_frame>Change from baseline to 5-week follow-up</time_frame>
    <description>Self-reported ease or difficulty with disclosing information about sexuality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Self Disclosure Scale (Herold &amp; Way)</measure>
    <time_frame>Change from baseline to 5-week follow-up</time_frame>
    <description>Degree of past sexual disclosure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Female Sexual Function Index</measure>
    <time_frame>Change from baseline to 5-week follow-up</time_frame>
    <description>Female sexual function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Satisfaction Scale for Women</measure>
    <time_frame>Change from baseline to 5-week follow-up</time_frame>
    <description>Sexual satisfaction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Mental Health Wellness 1</condition>
  <arm_group>
    <arm_group_label>Immediate Interview</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 60-minute interview about women's health conducted immediately after baseline questionnaires.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Interview</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The interview is conducted after the follow-up questionnaires are completed, rather than after baseline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Immediate interview</intervention_name>
    <description>A women's health interview that obtains information about physical, mental, and sexual health, particularly relatively private sexual health-related attitudes and experiences, as well as conflicts and stress related to sexuality.</description>
    <arm_group_label>Immediate Interview</arm_group_label>
    <other_name>Women's Health Interview</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Arab American or Chaldean&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age 18-35&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Lumley, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wayne State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wayne State University</investigator_affiliation>
    <investigator_full_name>Mark A. Lumley</investigator_full_name>
    <investigator_title>Distinguished Professor</investigator_title>
  </responsible_party>
  <keyword>sexual health</keyword>
  <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/NCT03303326
org study id: 064917B3E
nct id: NCT03303326
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates how Arab American women's cultural values and sexual health are related
      to their physical and emotional health. The study will also examine whether engaging in a
      sexual health interview affects women's physical and emotional health.
Sexuality is an important aspect of health, in part because emotional conflicts over
      sexuality as well as unwanted sexual experiences can impact physical and psychological
      health; yet no studies have examined sexual health among Arab American women in the U.S.
      These women face the task of negotiating their heritage culture and the American culture in
      which they reside. This may result in bicultural identity conflict for some women as they try
      to negotiate these two identities, which may have implications for sexuality and sexual
      health due to the two cultures' disparate views on sexuality. Confidential discussion of
      these sensitive topics with a knowledgeable interviewer may yield beneficial effects.

      The overall goal of the current study is to fill the gap in the literature on Arab American
      sexual health by examining how sexual health is related to physical and psychological health.
      This will be accomplished using both: a) correlational findings about sexual, physical, and
      psychological health from information gathered through self-report questionnaires and a
      60-minute women's health interview; and b) an experimental test of the effects of the women's
      health interview on physical and psychological health. A sample of young adult Arab American
      women will be assessed at baseline via questionnaires for various constructs (sexual
      attitudes, cultural and religious identity, and physical and mental health), and then
      randomized to either an immediate or delayed health interview, with a 5-week follow-up
      reassessment.

      It is hypothesized that lower sexual well-being, negative sexual self-schemas, and unwanted
      sexual experiences will correlate with more somatic and psychological health symptoms and
      lower satisfaction with life. It is also hypothesized that participants who have the
      immediate interview will report greater reduction in somatic and psychological symptoms and a
      greater willingness to discuss sexual health with medical providers compared to participants
      who are not interviewed (i.e., have a delayed interview after follow-up assessment).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Patient Health Questionnaire
time frame: Change from baseline to 5-week follow-up
description: Physical symptoms
measure: Brief Symptom Inventory
time frame: Change from baseline to 5-week follow-up
description: Psychological symptoms
measure: Satisfaction with Life Scale
time frame: Change from baseline to 5-week follow-up
description: Satisfaction with life
measure: Sexual Self-Schema Scale
time frame: Change from baseline to 5-week follow-up
description: Sexual self-schemas
measure: Sexual Self Disclosure Scale (Catania)
time frame: Change from baseline to 5-week follow-up
description: Self-reported ease or difficulty with disclosing information about sexuality
measure: Sexual Self Disclosure Scale (Herold & Way)
time frame: Change from baseline to 5-week follow-up
description: Degree of past sexual disclosure
measure: Female Sexual Function Index
time frame: Change from baseline to 5-week follow-up
description: Female sexual function
measure: Sexual Satisfaction Scale for Women
time frame: Change from baseline to 5-week follow-up
description: Sexual satisfaction
arm group label: Immediate Interview
arm group type: Experimental
description: A 60-minute interview about women's health conducted immediately after baseline questionnaires.
arm group label: Delayed Interview
arm group type: No Intervention
description: The interview is conducted after the follow-up questionnaires are completed, rather than after baseline.
intervention type: Behavioral
intervention name: Immediate interview
description: A women's health interview that obtains information about physical, mental, and sexual health, particularly relatively private sexual health-related attitudes and experiences, as well as conflicts and stress related to sexuality.
arm group label: Immediate Interview
other name: Women's Health Interview
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Lumley, PhD
role: Principal Investigator
affiliation: Wayne State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wayne State University
investigator full name: Mark A. Lumley
investigator title: Distinguished Professor
sharing ipd: No