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Arab American Women's Health Study

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ClinicalTrials.gov Identifier: NCT03303326
Recruitment Status : Active, not recruiting
First Posted : October 6, 2017
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Mark A. Lumley, Wayne State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mental Health Wellness 1 Behavioral: Immediate interview Not Applicable

Detailed Description:

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Arab American Women's Health Study
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Interview
A 60-minute interview about women's health conducted immediately after baseline questionnaires.
Behavioral: Immediate interview
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.
Other Name: Women's Health Interview

No Intervention: Delayed Interview
The interview is conducted after the follow-up questionnaires are completed, rather than after baseline.



Primary Outcome Measures :
  1. Patient Health Questionnaire [ Time Frame: Change from baseline to 5-week follow-up ]
    Physical symptoms


Secondary Outcome Measures :
  1. Brief Symptom Inventory [ Time Frame: Change from baseline to 5-week follow-up ]
    Psychological symptoms

  2. Satisfaction with Life Scale [ Time Frame: Change from baseline to 5-week follow-up ]
    Satisfaction with life

  3. Sexual Self-Schema Scale [ Time Frame: Change from baseline to 5-week follow-up ]
    Sexual self-schemas

  4. Sexual Self Disclosure Scale (Catania) [ Time Frame: Change from baseline to 5-week follow-up ]
    Self-reported ease or difficulty with disclosing information about sexuality

  5. Sexual Self Disclosure Scale (Herold & Way) [ Time Frame: Change from baseline to 5-week follow-up ]
    Degree of past sexual disclosure

  6. Female Sexual Function Index [ Time Frame: Change from baseline to 5-week follow-up ]
    Female sexual function

  7. Sexual Satisfaction Scale for Women [ Time Frame: Change from baseline to 5-week follow-up ]
    Sexual satisfaction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Arab American or Chaldean
  • Female
  • Age 18-35

Exclusion Criteria:

  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303326


Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
Blue Cross Blue Shield of Michigan Foundation
Investigators
Principal Investigator: Mark Lumley, PhD Wayne State University

Responsible Party: Mark A. Lumley, Distinguished Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT03303326     History of Changes
Other Study ID Numbers: 064917B3E
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mark A. Lumley, Wayne State University:
sexual health