Anxiety DepressionNCT07274865
Prevalence of Psychiatric Problems Among Patients and Healthcare Providers in a Cardiology Department: A Cross-Sectional Study
An observational study of Anxiety Depression and Burnout, run by Assiut University at 1 site in Egypt.
Trial summary
The goal of this observational cross-sectional study is to determine the prevalence of psychiatric problems (depression, anxiety, stress, and burnout) among patients with cardiovascular diseases and healthcare providers working in the Department of Cardiovascular Medicine at Assiut University Heart Hospital. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression, Burnout, Sleep
- What is being tested?
- Psychological Assessment using Validated Questionnaires
- How many people
- 380 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2026to Mar 2028
- How long will I take part?
- 1 Day
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with cardiovascular diseases admitted to or attending the outpatient clinics of the Cardiology Department at Assiut University Heart Hospital, and healthcare providers (physicians, residents, nurses, and technicians) currently working in the same department.
Who may be able to join
- Patients
- Age ≥ 18 years. Diagnosed with a cardiovascular disease (e.g., ischemic heart disease, heart failure, valvular disease).
- Able to understand and complete self-administered questionnaires or participate in structured interviews.
- Provided informed written consent.
- Healthcare Providers
- Physicians, residents, nurses, or allied staff working in the Department of Cardiovascular Medicine for ≥6 months.
- Provided informed written consent.
Who cannot join
- Severe cognitive impairment or communication difficulties that prevent questionnaire completion.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut university hospital
Asyut, Asyut Governorate, 71515
Assiut university hospital, 0020882080150, vp_grad@aun.edu.eg
About this study
Official title: Prevalence of Psychiatric Problems Among Patients and Healthcare Providers in the Department of Cardiovascular Medicine
The goal of this observational cross-sectional study is to determine the prevalence of psychiatric problems (depression, anxiety, stress, and burnout) among patients with cardiovascular diseases and healthcare providers working in the Department of Cardiovascular Medicine at Assiut University Heart Hospital.
The main questions it aims to answer are:
- What is the prevalence of depression, anxiety, and stress among cardiovascular patients?
- What is the prevalence of burnout, depression, and anxiety among healthcare providers in the same department?
The study will also explore potential sociodemographic, occupational, and clinical factors associated with these psychological outcomes.
Read the detailed description
Cardiovascular diseases (CVDs) remain the leading cause of morbidity and mortality worldwide. Psychological comorbidities-such as depression, anxiety, post-traumatic stress disorder, and cognitive impairment-are highly prevalent among patients with CVD and are known to adversely affect treatment adherence, quality of life, and overall outcomes.
Similarly, healthcare professionals working in cardiovascular medicine are exposed to continuous psychological stress due to long working hours, critical decision-making, and frequent exposure to life-threatening situations. These stressors contribute to burnout, depression, anxiety, and reduced job satisfaction, all of which may negatively influence patient safety and workforce stability.
Despite the recognized importance of mental health in cardiology, limited data exist from low- and middle-income countries-particularly from Egypt-regarding the concurrent assessment of mental health among both patients and healthcare providers within the same clinical setting.
Therefore, this study aims to estimate the prevalence and correlates of psychiatric symptoms among cardiovascular patients and healthcare providers in a tertiary care center. The results are expected to guide the development of psychosocial support programs and promote mental health awareness in hospital cardiology departments.
Study Design:
Type: Cross-sectional, descriptive, hospital-based study
Setting: Assiut University Heart Hospital
Sample: ~380 cardiovascular patients (systematic random sampling) and all available healthcare providers (census approach)
Tools: Standardized and validated questionnaires including SCL-90R, PSS, PSQI, MBI, and COPE Inventory
Data Analysis: Descriptive and multivariate logistic regression analyses using SPSS v26
- Conditions
- Anxiety Depression, Burnout, Sleep
- Being tested
- Psychological Assessment using Validated Questionnaires
- Keywords
- psychiatric probldems in cardiologists, psychiatric problems in cardiovascular patients
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Assessment using Validated QuestionnairesOther
Participants will complete validated mental health questionnaires, including SCL-90R, COPE Inventory, Eysenck Personality Questionnaire, Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI). Healthcare providers will additionally complete the Maslach Burnout Inventory (MBI). No experimental treatment or behavioral intervention will be applied.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the prevalence of depressive symptoms among cardiovascular patients assessed by SCL-90R
The Symptom Checklist-90-Revised (SCL-90R) will be used to assess depression subscale scores among patients with cardiovascular diseases. A predefined cutoff score indicates the presence of depressive symptoms.
Unit of measure: Percentage of participants with depressive symptoms (%)
Measured: Within 12 months
Measuring the prevalence of anxiety symptoms among cardiovascular patients assessed by SCL-90R
Anxiety subscale of SCL-90R will be used to quantify anxiety symptoms in patients.
Unit of measure : Percentage of participants with anxiety symptoms (%)
Measured: Within 12 months
Prevalence of burnout among healthcare providers assessed by Maslach Burnout Inventory (MBI)
The Maslach Burnout Inventory (MBI) will be used to assess emotional exhaustion, depersonalization, and personal accomplishment among cardiology staff.
Unit of measure : Percentage of participants meeting burnout criteria (%)
Measured: Within 12 months
Secondary outcomes (2)
Association between sociodemographic and clinical factors and psychiatric symptoms
Multivariate logistic regression will be used to identify predictors (e.g., age, sex, job type, disease severity) associated with depression, anxiety, and burnout.
Unit is Odds ratio (95% CI).
Measured: within 12 months
Mean Perceived Stress Scale (PSS) score among patients and providers
Perceived Stress Scale will be used to measure stress levels; higher scores indicate greater perceived stress.
Unit of measure : Mean PSS score (0-40)
Measured: within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 380 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Loly Abdulhameed Abdullah, Assiut University
- Investigators
- Ali Mohammed Tohamy, Ass. Professor, Study director, Assiut UniversityAyman Khairy Hassan, Professor, Study director, Assiut UniversityHossam Loly Abdullah, bachelor's, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274865
- Sponsor's protocol ID
- psychiatry in cardiology
- Status last verified
- Dec 2025
- First submitted
- 25 Sep 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11556941Shanafelt TD, Boone S, Tan L, Dyrbye LN, Sotile W, Satele D, West CP, Sloan J, Oreskovich MR. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012 Oct 8;172(18):1377-85. doi: 10.1001/archinternmed.2012.3199.
PubMed 22911330Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Lichtman JH, Froelicher ES, Blumenthal JA, Carney RM, Doering LV, Frasure-Smith N, Freedland KE, Jaffe AS, Leifheit-Limson EC, Sheps DS, Vaccarino V, Wulsin L; American Heart Association Statistics Committee of the Council on Epidemiology and Prevention and the Council on Cardiovascular and Stroke Nursing. Depression as a risk factor for poor prognosis among patients with acute coronary syndrome: systematic review and recommendations: a scientific statement from the American Heart Association. Circulation. 2014 Mar 25;129(12):1350-69. doi: 10.1161/CIR.0000000000000019. Epub 2014 Feb 24.
PubMed 24566200
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Psychiatric Problems Among Patients and Healthcare Providers in the Department of Cardiovascular Medicine
- ClinicalTrials.gov ID
- NCT07274865
- Acronym / sponsor ID
- psychiatry in cardiology
- Conditions
- Anxiety Depression, Burnout, Sleep
- Keywords
- psychiatric probldems in cardiologists, psychiatric problems in cardiovascular patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Dec 2025 (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.
The goal of this observational cross-sectional study is to determine the prevalence of psychiatric problems (depression, anxiety, stress, and burnout) among patients with cardiovascular diseases and healthcare providers working in the Department of Cardiovascular Medicine at Assiut University Heart Hospital.
The main questions it aims to answer are:
- What is the prevalence of depression, anxiety, and stress among cardiovascular patients?
- What is the prevalence of burnout, depression, and anxiety among healthcare providers in the same department?
The study will also explore potential sociodemographic, occupational, and clinical factors associated with these psychological outcomes.
Detailed description
Cardiovascular diseases (CVDs) remain the leading cause of morbidity and mortality worldwide. Psychological comorbidities-such as depression, anxiety, post-traumatic stress disorder, and cognitive impairment-are highly prevalent among patients with CVD and are known to adversely affect treatment adherence, quality of life, and overall outcomes.
Similarly, healthcare professionals working in cardiovascular medicine are exposed to continuous psychological stress due to long working hours, critical decision-making, and frequent exposure to life-threatening situations. These stressors contribute to burnout, depression, anxiety, and reduced job satisfaction, all of which may negatively influence patient safety and workforce stability.
Despite the recognized importance of mental health in cardiology, limited data exist from low- and middle-income countries-particularly from Egypt-regarding the concurrent assessment of mental health among both patients and healthcare providers within the same clinical setting.
Therefore, this study aims to estimate the prevalence and correlates of psychiatric symptoms among cardiovascular patients and healthcare providers in a tertiary care center. The results are expected to guide the development of psychosocial support programs and promote mental health awareness in hospital cardiology departments.
Study Design:
Type: Cross-sectional, descriptive, hospital-based study
Setting: Assiut University Heart Hospital
Sample: ~380 cardiovascular patients (systematic random sampling) and all available healthcare providers (census approach)
Tools: Standardized and validated questionnaires including SCL-90R, PSS, PSQI, MBI, and COPE Inventory
Data Analysis: Descriptive and multivariate logistic regression analyses using SPSS v26
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with cardiovascular diseases admitted to or attending the outpatient clinics of the Cardiology Department at Assiut University Heart Hospital, and healthcare providers (physicians, residents, nurses, and technicians) currently working in the same department.
Key inclusion criteria (7 listed)
- Patients
- Age ≥ 18 years. Diagnosed with a cardiovascular disease (e.g., ischemic heart disease, heart failure, valvular disease).
- Able to understand and complete self-administered questionnaires or participate in structured interviews.
- Provided informed written consent.
- Healthcare Providers
Key exclusion criteria (2 listed)
- Severe cognitive impairment or communication difficulties that prevent questionnaire completion.
- Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological Assessment using Validated QuestionnairesParticipants will complete validated mental health questionnaires, including SCL-90R, COPE Inventory, Eysenck Personality Questionnaire, Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI). Healthcare providers will additionally complete the Maslach Burnout Inventory (MBI). No experimental treatment or behavioral intervention will be applied. | Other | – |
Primary outcome
Measuring the prevalence of depressive symptoms among cardiovascular patients assessed by SCL-90R
Time frame: Within 12 months
The Symptom Checklist-90-Revised (SCL-90R) will be used to assess depression subscale scores among patients with cardiovascular diseases. A predefined cutoff score indicates the presence of depressive symptoms. Unit of measure: Percentage of participants with depressive symptoms (%)
Measuring the prevalence of anxiety symptoms among cardiovascular patients assessed by SCL-90R
Time frame: Within 12 months
Anxiety subscale of SCL-90R will be used to quantify anxiety symptoms in patients. Unit of measure : Percentage of participants with anxiety symptoms (%)
Prevalence of burnout among healthcare providers assessed by Maslach Burnout Inventory (MBI)
Time frame: Within 12 months
The Maslach Burnout Inventory (MBI) will be used to assess emotional exhaustion, depersonalization, and personal accomplishment among cardiology staff. Unit of measure : Percentage of participants meeting burnout criteria (%)
2 secondary outcomes
Association between sociodemographic and clinical factors and psychiatric symptoms
Time frame: within 12 months
Mean Perceived Stress Scale (PSS) score among patients and providers
Time frame: within 12 months
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 10 Dec 2025.
- 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.
- Results publication: PubMed 22911330Shanafelt TD, Boone S, Tan L, Dyrbye LN, Sotile W, Satele D, West CP, Sloan J, Oreskovich MR. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012 Oct 8;172(18):1377-85. doi: 10.1001/archinternmed.2012.3199.
- Results publication: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Results publication: PubMed 24566200Lichtman JH, Froelicher ES, Blumenthal JA, Carney RM, Doering LV, Frasure-Smith N, Freedland KE, Jaffe AS, Leifheit-Limson EC, Sheps DS, Vaccarino V, Wulsin L; American Heart Association Statistics Committee of the Council on Epidemiology and Prevention and the Council on Cardiovascular and Stroke Nursing. Depression as a risk factor for poor prognosis among patients with acute coronary syndrome: systematic review and recommendations: a scientific statement from the American Heart Association. Circulation. 2014 Mar 25;129(12):1350-69. doi: 10.1161/CIR.0000000000000019. Epub 2014 Feb 24.
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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.
Ali Mohammed Tohamy, Ass. Professor study director
Assiut University
Ayman Khairy Hassan, Professor study director
Assiut University
Hossam Loly Abdullah, bachelor's principal investigator
Assiut 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 Anxiety Depression and Burnout, run by Assiut University at 1 site in Egypt.
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 7 inclusion and 2 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 10 Dec 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 Egypt. 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 Hossam Loly Abdullah, bachelor's (00201279533575, hossam.17289754@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the prevalence of depressive symptoms among cardiovascular patients assessed by SCL-90R (time frame: Within 12 months). 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 NCT07274865, which also lists 4 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 10 Dec 2025.