DepressionPHQ-9NCT06734169
Depression Among Cardiothoracic Surgery Patients in Baghdad
An observational study of Depression, 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 in the Cardiothoracic Surgery Ward in Baghdad City, Iraq, using a 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
- How many people
- 200 participants
- Where
- 1 siteIraq
- Study dates
- 20 Apr 2025to 12 Jun 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 population will consist of adult patients (18 years and older) admitted to the cardiothoracic surgery ward at Al-Kadhimiya Teaching Hospital in Baghdad.
Who may be able to join
- Patients admitted to the cardiothoracic surgery ward.
- Patients who are able to understand and provide informed consent.
- Patients who have the cognitive ability to complete the PHQ-9 questionnaire.
Who cannot join
- Patients with a history of diagnosed psychiatric disorders other than depression.
- Patients who are critically ill or in a life-threatening condition and unable to participate.
- Patients who are unable to understand the PHQ-9 questionnaire due to language or cognitive barriers.
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
College of Medicine - Al-Nahrain University
Baghdad
Abdul-Ilah R. Khamis, +9647838571013, allaabed987@ced.nahrainuniv.edu.iq
Luma K Mohammed, +964770225676, lumakmohammed@nahrainuniv.edu.iq
About this study
Official title: Depression Among Cardiothoracic Patients in Baghdad: A Cross-Sectional PHQ-9 Study
This observational study aims to estimate the prevalence and severity of depression among patients in the Cardiothoracic Surgery Ward in Baghdad City, Iraq, using a self-administered PHQ-9 questionnaire. The main questions it aims to answer are:
What is the prevalence of depression among cardiothoracic surgery patients? How is the severity of depression distributed within this group? Are there specific environmental or demographic factors associated with higher levels of depression?
Read more
Participants will:
Fill out the PHQ-9 in order to measure the severity of depressive symptoms at a specific moment in time.
Demographic and clinical variables such as age, gender, socioeconomic status, surgery type, comorbidities, and hospital stay length should be taken to look for a possible relationship with depression.
Read the detailed description
Depression is a common mental health condition that frequently coexists with chronic illnesses and surgical conditions, including cardiothoracic surgeries, significantly impacting recovery and long-term health outcomes. Studies have established a link between depressive symptoms and adverse postoperative results, including prolonged hospital stays, decreased quality of life, and increased mortality rates. In surgical populations, depression often remains undetected and untreated, exacerbating its negative effects on patient outcomes.
In Iraq, particularly in Baghdad, the prevalence of depression among cardiothoracic surgery patients is not well documented. The region's ongoing socio-economic challenges, coupled with limited access to mental health resources, pose additional barriers to adequate psychological care. Addressing these challenges requires robust data to inform targeted interventions.
The Patient Health Questionnaire-9 (PHQ-9) is a validated and widely used tool for screening depression in clinical and nonclinical populations It consists of nine questions that assess the frequency of depressive symptoms over the past two weeks, with scores ranging from 0 to 27. Diagnostic Cut-off: A score of ≥10 is often used as a threshold for identifying major depressive disorder with a high degree of sensitivity and specificity. Additionally, changes in PHQ-9 scores over time are used to evaluate the effectiveness of treatment. Its applicability in diverse populations makes it suitable for assessing depression among cardiothoracic surgery patients in Baghdad .
Baghdad is a region with limited local data on mental health, making it crucial to understand the mental health burden in surgical populations. This study aims to investigate the prevalence and severity of depression in this patient group, providing critical insights to bridge the gap in mental health care and improve surgical outcomes.
- Conditions
- Depression
- Keywords
- PHQ-9
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Depression
Proportion of cardiothoracic surgery patients at Al-Kadhimiya Teaching Hospital who exhibit depressive symptoms.
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.
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 posted16 Dec 2024
- Study start20 Apr 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion12 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Cross-sectional
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734169
- Sponsor's protocol ID
- UNCOMIRB20241210C
- Other IDs
- 011
- Acronym
- PHQ-9
- Status last verified
- Mar 2025
- First submitted
- 10 Dec 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
McCormick KM, Naimark BJ, Tate RB. Uncertainty, symptom distress, anxiety, and functional status in patients awaiting coronary artery bypass surgery. Heart Lung. 2006 Jan-Feb;35(1):34-45. doi: 10.1016/j.hrtlng.2005.08.002.
PubMed 16426934Underwood MJ, Firmin RK, Jehu D. Aspects of psychological and social morbidity in patients awaiting coronary artery bypass grafting. Br Heart J. 1993 May;69(5):382-4. doi: 10.1136/hrt.69.5.382.
PubMed 8518057Tully PJ, Baker RA. Depression, anxiety, and cardiac morbidity outcomes after coronary artery bypass surgery: a contemporary and practical review. J Geriatr Cardiol. 2012 Jun;9(2):197-208. doi: 10.3724/SP.J.1263.2011.12221.
PubMed 22916068Morys JM, Bellwon J, Hofer S, Rynkiewicz A, Gruchala M. Quality of life in patients with coronary heart disease after myocardial infarction and with ischemic heart failure. Arch Med Sci. 2016 Apr 1;12(2):326-33. doi: 10.5114/aoms.2014.47881. Epub 2015 Jan 14.
PubMed 27186176Tully PJ, Baker RA, Winefield HR, Turnbull DA. Depression, anxiety disorders and Type D personality as risk factors for delirium after cardiac surgery. Aust N Z J Psychiatry. 2010 Nov;44(11):1005-11. doi: 10.3109/00048674.2010.495053.
PubMed 21034183Stenman M, Sartipy U. Depression Screening in Cardiac Surgery Patients. Heart Lung Circ. 2019 Jun;28(6):953-958. doi: 10.1016/j.hlc.2018.04.298. Epub 2018 May 16.
PubMed 29871802Manea L, Gilbody S, McMillan D. Optimal cut-off score for diagnosing depression with the Patient Health Questionnaire (PHQ-9): a meta-analysis. CMAJ. 2012 Feb 21;184(3):E191-6. doi: 10.1503/cmaj.110829. Epub 2011 Dec 19.
PubMed 22184363Sadik S, Bradley M, Al-Hasoon S, Jenkins R. Public perception of mental health in Iraq. Int J Ment Health Syst. 2010 Oct 11;4:26. doi: 10.1186/1752-4458-4-26.
PubMed 20937100Murphy BM, Elliott PC, Higgins RO, Le Grande MR, Worcester MU, Goble AJ, Tatoulis J. Anxiety and depression after coronary artery bypass graft surgery: most get better, some get worse. Eur J Cardiovasc Prev Rehabil. 2008 Aug;15(4):434-40. doi: 10.1097/HJR.0b013e3282fbc945.
PubMed 18677168Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941
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
- Depression Among Cardiothoracic Patients in Baghdad: A Cross-Sectional PHQ-9 Study
- ClinicalTrials.gov ID
- NCT06734169
- Acronym / sponsor ID
- PHQ-9 / UNCOMIRB20241210C
- Conditions
- Depression
- Keywords
- PHQ-9
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Al-Nahrain UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 12 Jun 2025 (estimated)
- First posted
- 16 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 in the Cardiothoracic Surgery Ward in Baghdad City, Iraq, using a self-administered PHQ-9 questionnaire. The main questions it aims to answer are:
What is the prevalence of depression among cardiothoracic surgery patients? How is the severity of depression distributed within this group? Are there specific environmental or demographic factors associated with higher levels of depression?
Participants will:
Fill out the PHQ-9 in order to measure the severity of depressive symptoms at a specific moment in time.
Demographic and clinical variables such as age, gender, socioeconomic status, surgery type, comorbidities, and hospital stay length should be taken to look for a possible relationship with depression.
Detailed description
Depression is a common mental health condition that frequently coexists with chronic illnesses and surgical conditions, including cardiothoracic surgeries, significantly impacting recovery and long-term health outcomes. Studies have established a link between depressive symptoms and adverse postoperative results, including prolonged hospital stays, decreased quality of life, and increased mortality rates. In surgical populations, depression often remains undetected and untreated, exacerbating its negative effects on patient outcomes.
In Iraq, particularly in Baghdad, the prevalence of depression among cardiothoracic surgery patients is not well documented. The region's ongoing socio-economic challenges, coupled with limited access to mental health resources, pose additional barriers to adequate psychological care. Addressing these challenges requires robust data to inform targeted interventions.
The Patient Health Questionnaire-9 (PHQ-9) is a validated and widely used tool for screening depression in clinical and nonclinical populations It consists of nine questions that assess the frequency of depressive symptoms over the past two weeks, with scores ranging from 0 to 27. Diagnostic Cut-off: A score of ≥10 is often used as a threshold for identifying major depressive disorder with a high degree of sensitivity and specificity. Additionally, changes in PHQ-9 scores over time are used to evaluate the effectiveness of treatment. Its applicability in diverse populations makes it suitable for assessing depression among cardiothoracic surgery patients in Baghdad .
Baghdad is a region with limited local data on mental health, making it crucial to understand the mental health burden in surgical populations. This study aims to investigate the prevalence and severity of depression in this patient group, providing critical insights to bridge the gap in mental health care and improve surgical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients (18 years and older) admitted to the cardiothoracic surgery ward at Al-Kadhimiya Teaching Hospital in Baghdad.
Key inclusion criteria (3 listed)
- Patients admitted to the cardiothoracic surgery ward.
- Patients who are able to understand and provide informed consent.
- Patients who have the cognitive ability to complete the PHQ-9 questionnaire.
Key exclusion criteria (3 listed)
- Patients with a history of diagnosed psychiatric disorders other than depression.
- Patients who are critically ill or in a life-threatening condition and unable to participate.
- Patients who are unable to understand the PHQ-9 questionnaire due to language or cognitive barriers.
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-months period, with each participant completing the PHQ-9 assessment at a single point during this time frame.
Proportion of cardiothoracic surgery patients at Al-Kadhimiya Teaching Hospital 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 16426934McCormick KM, Naimark BJ, Tate RB. Uncertainty, symptom distress, anxiety, and functional status in patients awaiting coronary artery bypass surgery. Heart Lung. 2006 Jan-Feb;35(1):34-45. doi: 10.1016/j.hrtlng.2005.08.002.
- Background: PubMed 8518057Underwood MJ, Firmin RK, Jehu D. Aspects of psychological and social morbidity in patients awaiting coronary artery bypass grafting. Br Heart J. 1993 May;69(5):382-4. doi: 10.1136/hrt.69.5.382.
- Background: PubMed 22916068Tully PJ, Baker RA. Depression, anxiety, and cardiac morbidity outcomes after coronary artery bypass surgery: a contemporary and practical review. J Geriatr Cardiol. 2012 Jun;9(2):197-208. doi: 10.3724/SP.J.1263.2011.12221.
- Background: PubMed 27186176Morys JM, Bellwon J, Hofer S, Rynkiewicz A, Gruchala M. Quality of life in patients with coronary heart disease after myocardial infarction and with ischemic heart failure. Arch Med Sci. 2016 Apr 1;12(2):326-33. doi: 10.5114/aoms.2014.47881. Epub 2015 Jan 14.
- Background: PubMed 21034183Tully PJ, Baker RA, Winefield HR, Turnbull DA. Depression, anxiety disorders and Type D personality as risk factors for delirium after cardiac surgery. Aust N Z J Psychiatry. 2010 Nov;44(11):1005-11. doi: 10.3109/00048674.2010.495053.
- Results publication: PubMed 29871802Stenman M, Sartipy U. Depression Screening in Cardiac Surgery Patients. Heart Lung Circ. 2019 Jun;28(6):953-958. doi: 10.1016/j.hlc.2018.04.298. Epub 2018 May 16.
- Results publication: PubMed 22184363Manea L, Gilbody S, McMillan D. Optimal cut-off score for diagnosing depression with the Patient Health Questionnaire (PHQ-9): a meta-analysis. CMAJ. 2012 Feb 21;184(3):E191-6. doi: 10.1503/cmaj.110829. Epub 2011 Dec 19.
- Results publication: PubMed 20937100Sadik S, Bradley M, Al-Hasoon S, Jenkins R. Public perception of mental health in Iraq. Int J Ment Health Syst. 2010 Oct 11;4:26. doi: 10.1186/1752-4458-4-26.
- Results publication: PubMed 18677168Murphy BM, Elliott PC, Higgins RO, Le Grande MR, Worcester MU, Goble AJ, Tatoulis J. Anxiety and depression after coronary artery bypass graft surgery: most get better, some get worse. Eur J Cardiovasc Prev Rehabil. 2008 Aug;15(4):434-40. doi: 10.1097/HJR.0b013e3282fbc945.
- Results publication: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- 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.
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, 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 3 inclusion and 3 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: opening soon, 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-months period, with each participant completing the PHQ-9 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 NCT06734169, which also lists 10 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.