Anxiety Disorders, Depression and Related Factors in PCOS

Sponsor
Mỹ Đức Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05864690
Collaborator
(none)
768
1
9.7
79

Study Details

Study Description

Brief Summary

Polycystic ovary syndrome (PCOS) is a systemic neuro-endocrine-metabolic-reproductive disorder, common in women of reproductive age, affecting 21.27% of women worldwide and the rate of PCOS has been increasing over the past decade.

Women with PCOS have many health problems, including insulin resistance, hyperandrogenemia, and ovulation disorders. Moreover, PCOS is also associated with significant consequences such as increased risk of cardiovascular disease, glucose intolerance and diabetes mellitus (both type 2 and gestational), increased risk of endometrial hyperplasia and endometrial cancer and mental health disorders.

A meta-analysis of 57 studies has been reported that women with PCOS are more likely to have an increased risk of diagnosis of depression, anxiety, bipolar disorder, and obsessive-compulsive disorder.

These psychological disorders may be related to biometric and biochemical characteristics in women with PCOS, such as body image, hirsutism or acne. Furthermore, researches showed that waist-to-hip ratio and plasmatic levels of testosterone is inversely related to anxiety, psychoticism, hostility and to the indexes of psychological distress. Psychological consequences may also be related to other factors, including stigmatization and isolation, the lack of empathy from family and friends, the feeling of guilt and the diminished sense of self-worth, the costs of treatment and treatment outcomes.

However, there has been no data on the psychological disorders in infertile women with PCOS. Therefore, the study aimed to determine the prevalence of anxiety disorders, depression in infertile women with PCOS and associated factors.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    • This trial will be conducted at My Duc Hospital, Ho Chi Minh City, Viet Nam.

    • Women who are potentially eligible will be provided information about the study purposes, procedures, related risk and benefits

    • Screening for eligibility will be performed on the day of the first visit when diagnosis about PCOS is established.

    • Patients will be provided information related to the study together with the informed consent documents. Signed informed consent forms will be obtained by the investigators from all women before the enrolment.

    • All patients selected for this study will answer the questionares and complete the GAD-7 GAD-7 (General Anxiety Disorder-7) and PHQ-9 (Patient Health Questionnaire-9) following careful instruction on how to complete the instrument by investigator in a private room without the presence of their husband.

    • The survey will last about 15 minutes. If the result of the GAD-7 and PHQ-9 suggested anxiety disorders, depression, the patient will refer to specialists for further assessment and treatment.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    768 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevalence of Anxiety Disorders, Depression and Related Factors in Vietnamese Infertile Women With Polycystic Ovarian Syndrome
    Actual Study Start Date :
    May 8, 2023
    Anticipated Primary Completion Date :
    Dec 30, 2023
    Anticipated Study Completion Date :
    Feb 28, 2024

    Outcome Measures

    Primary Outcome Measures

    1. The prevalence of anxiety disorders [immediately after the interview]

      The prevalence of anxiety disorders using General Anxiety Disorder-7 (GAD-7). The minimum values is 0 and maximum values is 21. Using cutoff score 10 with sensitivity 89% and specificity 82% for any anxiety disorder. Higher GAD-7 scores correlate with disability and functional impairment (in measures such as work productivity and health care utilization.

    2. The prevalence of depression [immediately after the interview]

      The prevalence of depression using Patient Health Questionnaire -9 (PHQ-9). The minimum values is 0 and maximum values is 27. PHQ-9 scores ≥10 were found to be 88% sensitive and also 88% specific for detecting major depressive disorder. Higher PHQ-9 scores are associated with decreased functional status and increased symptom-related difficulties, sick days, and healthcare utilization.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Infertile Vietnamese women

    • Reporting PCOS according to Rotterdam 2003

    • Agreement to participate in the study

    Exclusion Criteria:
    • Having a family history of neuropsychiatric disease

    • Patients who are deaf, blind, or born dumb

    • Patents cannot understand Vietnamese

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 My Duc Hospital Ho Chi Minh City Vietnam 70000

    Sponsors and Collaborators

    • Mỹ Đức Hospital

    Investigators

    • Principal Investigator: Lan N Vuong, PhD, MD, IVFMD and HOPE Research Center, My Duc Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mỹ Đức Hospital
    ClinicalTrials.gov Identifier:
    NCT05864690
    Other Study ID Numbers:
    • 04/23/DD-BVMD
    First Posted:
    May 18, 2023
    Last Update Posted:
    May 18, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mỹ Đức Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2023