NCT07274865

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Jan 2026

Typical duration 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

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Study Timeline

Key milestones and dates

Study Progress16%
Jan 2026Mar 2028

First Submitted

Initial submission to the registry

September 25, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

September 25, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

psychiatric probldems in cardiologistspsychiatric problems in cardiovascular patients

Outcome Measures

Primary Outcomes (3)

  • 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 (%)

    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 (%)

    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 (%)

    Within 12 months

Secondary Outcomes (2)

  • Association between sociodemographic and clinical factors and psychiatric symptoms

    within 12 months

  • Mean Perceived Stress Scale (PSS) score among patients and providers

    within 12 months

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Severe cognitive impairment or communication difficulties that prevent questionnaire completion.
  • Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (4)

  • 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.

  • Shanafelt 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.

  • Spitzer 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.

  • Lichtman 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.

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Ali Mohammed Tohamy, Ass. Professor

    Assiut University

    STUDY DIRECTOR
  • Ayman Khairy Hassan, Professor

    Assiut University

    STUDY DIRECTOR
  • Hossam Loly Abdullah, bachelor's

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hossam Loly Abdullah, bachelor's

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

September 25, 2025

First Posted

December 10, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations