NCT06734169

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

December 10, 2024

Last Update Submit

March 16, 2025

Conditions

Keywords

PHQ-9

Outcome Measures

Primary Outcomes (3)

  • Prevalence of Depression

    Proportion of cardiothoracic surgery patients at Al-Kadhimiya Teaching Hospital who exhibit depressive symptoms.

    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.

    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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine - Al-Nahrain University

Baghdad, Iraq

Location

Related Publications (10)

  • 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.

    PMID: 16426934BACKGROUND
  • Underwood 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.

    PMID: 8518057BACKGROUND
  • Tully 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.

    PMID: 22916068BACKGROUND
  • Morys 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.

    PMID: 27186176BACKGROUND
  • Tully 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.

    PMID: 21034183BACKGROUND
  • Stenman 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.

  • Manea 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.

  • Sadik 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.

  • Murphy 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.

  • Kroenke 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.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 16, 2024

Study Start

April 20, 2025

Primary Completion

June 1, 2025

Study Completion

June 12, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations