Mental Health Wellness 1NCT03303326
Arab American Women's Health Study
A study testing Immediate interview in people with Mental Health Wellness 1, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Immediate interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2017to 24 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Arab American or Chaldean
- Female
- Age 18-35
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Mental Health Wellness 1
- Being tested
- Immediate interview
- Keywords
- sexual health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate interviewBehavioural
Also called Women's Health 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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Interview | Experimental | A 60-minute interview about women's health conducted immediately after baseline questionnaires. Receives: Behavioral: Immediate interview |
| Delayed Interview | No intervention | The interview is conducted after the follow-up questionnaires are completed, rather than after baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire
Physical symptoms
Measured: Change from baseline to 5-week follow-up
Secondary outcomes (7)
Brief Symptom Inventory
Psychological symptoms
Measured: Change from baseline to 5-week follow-up
Satisfaction with Life Scale
Satisfaction with life
Measured: Change from baseline to 5-week follow-up
Sexual Self-Schema Scale
Sexual self-schemas
Measured: Change from baseline to 5-week follow-up
Sexual Self Disclosure Scale (Catania)
Self-reported ease or difficulty with disclosing information about sexuality
Measured: Change from baseline to 5-week follow-up
Sexual Self Disclosure Scale (Herold & Way)
Degree of past sexual disclosure
Measured: Change from baseline to 5-week follow-up
Female Sexual Function Index
Female sexual function
Measured: Change from baseline to 5-week follow-up
Sexual Satisfaction Scale for Women
Sexual satisfaction
Measured: Change from baseline to 5-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start28 Sep 2017
- Primary completion24 May 2018
- Study completion24 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Mark A. Lumley, Wayne State University
- Investigators
- Mark Lumley, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303326
- Sponsor's protocol ID
- 064917B3E
- Status last verified
- Oct 2018
- First submitted
- 2 Oct 2017
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arab American Women's Health Study
- ClinicalTrials.gov ID
- NCT03303326
- Acronym / sponsor ID
- 064917B3E
- Conditions
- Mental Health Wellness 1
- Keywords
- sexual health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Interview | Experimental | Behavioral: Immediate interviewA 60-minute interview about women's health conducted immediately after baseline questionnaires. |
| Delayed Interview | No intervention | –The interview is conducted after the follow-up questionnaires are completed, rather than after baseline. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Arab American or Chaldean
- Female
- Age 18-35
Key exclusion criteria (1 listed)
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate interviewAlso: Women's Health InterviewA 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. | Behavioural | Immediate Interview |
Primary outcome
Patient Health Questionnaire
Time frame: Change from baseline to 5-week follow-up
Physical symptoms
7 secondary outcomes
Brief Symptom Inventory
Time frame: Change from baseline to 5-week follow-up
Satisfaction with Life Scale
Time frame: Change from baseline to 5-week follow-up
Sexual Self-Schema Scale
Time frame: Change from baseline to 5-week follow-up
Sexual Self Disclosure Scale (Catania)
Time frame: Change from baseline to 5-week follow-up
Sexual Self Disclosure Scale (Herold & Way)
Time frame: Change from baseline to 5-week follow-up
Female Sexual Function Index
Time frame: Change from baseline to 5-week follow-up
Sexual Satisfaction Scale for Women
Time frame: Change from baseline to 5-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Lumley, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate interview in people with Mental Health Wellness 1, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (time frame: Change from baseline to 5-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.