Anxiety Disorders, Depression and Related Factors in PCOS

March 14, 2024 updated by: Mỹ Đức Hospital

Prevalence of Anxiety Disorders, Depression and Related Factors in Vietnamese Infertile Women With Polycystic Ovarian Syndrome

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

768

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 70000
        • Recruiting
        • My Duc Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Infertile Vietnamese women with PCOS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of anxiety disorders
Time Frame: 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.
immediately after the interview
The prevalence of depression
Time Frame: 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.
immediately after the interview

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mỹ Đức Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/23/DD-BVMD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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