Depression - Major Depressive DisorderPAD-CADNCT06740396
Prevalence and Severity of Depression in Coronary Artery Disease Patients
An observational study of Depression - Major Depressive Disorder, run by Al-Nahrain University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder
- How many people
- 200 participants
- Where
- 1 siteIraq
- Study dates
- 20 Feb 2025to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
College of Medicine - Al-Nahrain University
Baghdad
Aws Al-Rubaye lecturer, Internal Medicine, +9647730288897, awsalrubaye@nahrainuniv.edu.iq
Abdul-Ilah R. Khamis
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- PHQ-9
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Depression
Proportion of coronary artery disease patients in Baghdad who exhibit depressive symptoms.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start20 Feb 2025
- Primary completion20 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Nahrain University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul-Ilah R. Khamis, Al-Nahrain University
- Investigators
- Aws Al-Rubaye Lecturer, Internal Medicine, Study director, College Of Medicine - Nahrain University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740396
- Sponsor's protocol ID
- UNCOMIRB20241214
- Other IDs
- 016
- Acronym
- PAD-CAD
- Status last verified
- Mar 2025
- First submitted
- 14 Dec 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36871435Bremner 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.
PubMed 30508746Levis 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.
PubMed 30967483Swenson 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.
PubMed 15538992Rudisch 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.
PubMed 12893099
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Prevalence and Severity of Depression Among Coronary Artery Diseases Patients in Baghdad Using the PHQ-9: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06740396
- Acronym / sponsor ID
- PAD-CAD / UNCOMIRB20241214
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- PHQ-9
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Al-Nahrain UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 20 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 18 Dec 2024 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 36871435Akosile 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.
- Background: PubMed 30508746Bremner 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.
- Results publication: PubMed 30967483Levis 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.
- Results publication: PubMed 15538992Swenson 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.
- Results publication: PubMed 12893099Rudisch 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.
- 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.
Aws Al-Rubaye Lecturer, Internal Medicine study director
College Of Medicine - Nahrain University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression - Major Depressive Disorder, run by Al-Nahrain University at 1 site in Iraq.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Mar 2025. 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdul-Ilah R. Khamis (+9647838571013, allaabed987@ced.nahrainuniv.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06740396, which also lists 5 linked publications.
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 18 Mar 2025.