Prevalence and Severity of Depression in Coronary Artery Disease Patients

NCT06740396 | Recruiting DMC

• 2 other identifiers: UNCOMIRB20241214016
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression - Major Depressive Disorder

Keywords

PHQ-9

Outcome Measures

Primary Outcomes (3)

• Prevalence of Depression

  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.

• Severity of Depression

  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.

• Patient Health Questionnaire-9 (PHQ-9)

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Nahrain University: lead

Study Sites (1)

College of Medicine - Al-Nahrain University

Baghdad, Iraq

RECRUITING

Related Publications (5)

• Akosile W, Tiyatiye B, Colquhoun D, Young R. Management of depression in patients with coronary artery disease: A systematic review. Asian J Psychiatr. 2023 May;83:103534. doi: 10.1016/j.ajp.2023.103534. Epub 2023 Feb 28.

  PMID: 36871435 BACKGROUND

• Bremner JD, Campanella C, Khan Z, Fani N, Kasher N, Evans S, Reiff C, Mishra S, Ladd S, Nye JA, Raggi P, Vaccarino V. Brain mechanisms of stress and depression in coronary artery disease. J Psychiatr Res. 2019 Feb;109:76-88. doi: 10.1016/j.jpsychires.2018.11.017. Epub 2018 Nov 22.

  PMID: 30508746 BACKGROUND

• Levis B, Benedetti A, Thombs BD; DEPRESsion Screening Data (DEPRESSD) Collaboration. Accuracy of Patient Health Questionnaire-9 (PHQ-9) for screening to detect major depression: individual participant data meta-analysis. BMJ. 2019 Apr 9;365:l1476. doi: 10.1136/bmj.l1476.

  PMID: 30967483 RESULT

• Swenson JR. Quality of life in patients with coronary artery disease and the impact of depression. Curr Psychiatry Rep. 2004 Dec;6(6):438-45. doi: 10.1007/s11920-004-0008-x.

  PMID: 15538992 RESULT

• Rudisch B, Nemeroff CB. Epidemiology of comorbid coronary artery disease and depression. Biol Psychiatry. 2003 Aug 1;54(3):227-40. doi: 10.1016/s0006-3223(03)00587-0.

  PMID: 12893099 RESULT

Study Officials

• Aws Al-Rubaye Lecturer, Internal Medicine

  College Of Medicine - Nahrain University

  STUDY DIRECTOR

Central Study Contacts

Abdul-Ilah R. Khamis

CONTACT

+9647838571013; allaabed987@ced.nahrainuniv.edu.iq

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 18, 2024
• Study Start: February 20, 2025
• Primary Completion: April 20, 2025
• Study Completion: April 30, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)