Prevalence and Severity of Depression in Coronary Artery Disease Patients (PAD-CAD)

March 16, 2025 updated by: Abdul-Ilah R. Khamis, Al-Nahrain University

Assessing the Prevalence and Severity of Depression Among Coronary Artery Diseases Patients in Baghdad Using the PHQ-9: A Cross-Sectional Study

This observational study aims to estimate the prevalence and severity of depression among patients with coronary artery disease (CAD) in Baghdad, Iraq, using the self-administered PHQ-9 questionnaire. The study seeks to answer the following questions:

What is the prevalence of depression among CAD patients? How is the severity of depression distributed within this group? Are specific demographic, clinical, or environmental factors associated with higher levels of depression?

Participants will:

Complete the PHQ-9 to assess the severity of depressive symptoms at a specific point in time.

Provide demographic and clinical information, including age, gender, socioeconomic status, comorbidities, and CAD-related factors such as type of intervention and duration of illness, to explore potential correlations with depression.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Coronary artery disease (CAD) remains one of the leading causes of morbidity and mortality worldwide, with multiple risk factors influencing its onset and progression. Among the psychosocial factors associated with CAD, depression plays a particularly prominent role. Research indicates that while 17% to 27% of patients with CAD have major depression, a significantly larger percentage experience subsyndromal depressive symptoms. This highlights a widespread issue where depressive symptoms, even if not clinically classified as major depression, still contribute to poorer health outcomes in CAD patients. Major depression is not only prevalent among CAD patients but is also linked to an increased risk for developing CAD and higher mortality from the disease. However, the exact mechanisms through which depression impacts cardiovascular health remain unclear.

Coronary heart disease (CHD), a major manifestation of CAD, typically results from the rupture or erosion of an atherosclerotic plaque in the epicardial coronary arteries. Over 60 risk factors and markers have been associated with the initiation and progression of these plaques. When a plaque ruptures, it can stimulate acute thrombosis within the artery, leading to an acute coronary syndrome (ACS), which may present as a myocardial infarction (MI), unstable angina, or even sudden cardiac death. These risk factors can be broadly categorized into three groups: lifestyle, biological, and psychosocial. Depression, as a psychosocial risk factor, not only increases the likelihood of developing CAD but also contributes to worse outcomes in patients who already have the disease.

The impact of depression extends beyond its role in the progression of CAD; it significantly affects the quality of life (QOL) of patients with coronary disease. While treating depression may not necessarily reduce depression's role as a direct risk factor for CAD, improving the quality of life should be considered a primary goal of treatment. Defining and measuring QOL remains a challenge, but recent studies have shown a clear relationship between QOL, depression, and mortality risk in CAD patients. This underscores the importance of addressing both the psychological and physical health of CAD patients in clinical care.

Moreover, the PHQ-9 (Patient Health Questionnaire-9) is a widely used, self-administered tool designed to assess the severity of depression in individuals. Comprising nine simple, straightforward questions, the PHQ-9 evaluates the frequency of common depressive symptoms over the past two weeks, such as feelings of sadness, loss of interest, sleep disturbances, and fatigue. Each response is scored on a scale from 0 to 3, and the total score helps determine the severity of depression, ranging from minimal to severe. Originally developed as a screening tool, the PHQ-9 is now a key instrument in both clinical practice and research for diagnosing major depressive disorder (MDD), monitoring treatment progress, and identifying individuals at risk for worsening symptoms. A meta-analysis conducted in 2015, which included 36 studies with over 21,000 participants, evaluated the sensitivity and specificity of various cut-off scores ranging from 7 to 15. The analysis found that the standard cut-off of 10 had a pooled sensitivity of 0.78 and specificity of 0.87, suggesting it is a reasonably effective screening tool. However, the study also noted significant limitations, such as incomplete reporting on cut-off scores other than 10, which led to misleading results indicating that sensitivity increased with higher cut-off scores, possibly due to selective reporting in some studies.

Despite the well-established connection between depression and CAD in many parts of the world, there is a notable gap in research on this topic within Iraq. This study aims to assess the prevalence and severity of depression among CAD patients in Baghdad using the Patient Health Questionnaire-9 (PHQ-9), a widely recognized tool for diagnosing depression. By exploring the burden of depression in this patient population, this research will provide important insights into the mental health needs of CAD patients in Iraq and contribute to improving both cardiovascular outcomes and quality of life in this underserved region.

Study Type

Observational

Enrollment (Estimated)

200

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 Locations

  • Iraq
      • Baghdad, Iraq
        • Recruiting
        • College of Medicine - Al-Nahrain University
        • Principal Investigator:
          • Abdul-Ilah R. Khamis
        • Sub-Investigator:
          • Saja J. Abotaleb, M.B.CH.B
        • Sub-Investigator:
          • Ghaith M. taha, M.B.CH.B
        • Contact:
        • Sub-Investigator:
          • Wissal Fatih Student
        • Sub-Investigator:
          • Maryem Filal Student
        • Sub-Investigator:
          • Ali A. Jabbar, Student
        • Sub-Investigator:
          • Zainab Sinan Al-Hassani, M.B.Ch.B, F.I.C.M(psych)

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

The study will include adult patients diagnosed with coronary artery disease (CAD) who are receiving outpatient or inpatient care in selected hospitals in Baghdad, Iraq. Participants will represent a diverse population in terms of age, gender, socioeconomic status, and comorbid conditions. The study aims to capture the prevalence and severity of depression within this group, considering the physical and psychological burden associated with CAD. Efforts will be made to recruit a representative sample to ensure that findings are generalizable to the broader population of CAD patients in Baghdad.

Description

Inclusion Criteria:

  • Diagnosed with coronary artery disease (confirmed through clinical, imaging, or procedural evidence).
  • Receiving care at designated hospitals in Baghdad.
  • Able to understand and complete the PHQ-9 questionnaire independently or with minimal assistance.
  • Consents to participate in the study.

Exclusion Criteria:

  • Patients with a history of severe psychiatric disorders unrelated to depression (e.g., schizophrenia, bipolar disorder).
  • Patients with cognitive impairments or neurological conditions affecting their ability to complete the questionnaire.
  • Those currently hospitalized for acute cardiac events (e.g., myocardial infarction) requiring intensive care.
  • Individuals unwilling to provide informed consent.

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
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Data collection will occur over a 3-months period, with each participant completing the PHQ-9 assessment at a single point during this time frame.
The total score can range from 0 to 27. Higher scores indicate greater severity of depression.
Data collection will occur over a 3-months period, with each participant completing the PHQ-9 assessment at a single point during this time frame.
Severity of Depression
Time Frame: Data collection will occur over a 3-months period, with each participant completing the PHQ-9 assessment at a single point during this time frame.
The severity of depression in this study will be determined based on the scores obtained from the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 categorizes depression severity as follows: Minimal depression: Scores 0-4, indicating little to no symptoms. Mild depression: Scores 5-9, suggesting occasional symptoms that may not significantly affect daily functioning. Moderate depression: Scores 10-14, indicating more frequent symptoms that can interfere with daily life. Moderately severe depression: Scores 15-19, showing pronounced symptoms that significantly impact daily activities. Severe depression: Scores 20-27, with symptoms that are debilitating.
Data collection will occur over a 3-months period, with each participant completing the PHQ-9 assessment at a single point during this time frame.
Prevalence of Depression
Time Frame: Data collection will occur over a 3-month period, with each participant completing the assessment at a single point during this time frame.
Proportion of coronary artery disease patients in Baghdad who exhibit depressive symptoms.
Data collection will occur over a 3-month period, with each participant completing the assessment at a single point during this time frame.

Collaborators and Investigators

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

Sponsor

Al-Nahrain University

Investigators

  • Study Director: Aws Al-Rubaye Lecturer, Internal Medicine, College Of Medicine - Nahrain University

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)

February 20, 2025

Primary Completion (Estimated)

April 20, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

December 14, 2024

First Submitted That Met QC Criteria

December 14, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 16, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNCOMIRB20241214
  • 016 (Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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