- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04689464
COVID 19 and Psychological Health: a Cross Sectional Study to Evaluate Anxiety and Depression in Covid-19 Patients
COVID19 and Psychological Health: a Cross Sectional Evaluation of the Risks of Anxiety and Depression Among Patients Diagnosed With Covid 19
The covid-19 pandemic started to spread worldwide since December 2019. It promoted to an exaggerated psychological stress and anxiety in humans due to the intolerable symptoms higher than usual death of many infected patients. This study examines the corona related anxiety and if there is need for drug intervention to treat this anxiety.
To answer these questions, a survey made to the hospitalized patients including sex, age, educational level, Marital state, and a standardized questionnaires (GAD-7 and PHQ-9) which has been validated and shown to possess good psychometric qualities in studies of participants from multiple populations.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Basra, Iraq, 99999
- AlFayhaa Teaching hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients with COVID19 willing to participate in the study
Exclusion Criteria:
- unwilling unable to read or interact with standardized questionnaire unconscious
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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mild covid
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moderate covid
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severe covid
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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depression
Time Frame: at the time of acute infection, average of 1 month
|
Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale.
Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; >20 severe.
Minimum 0 maximum 27 points
|
at the time of acute infection, average of 1 month
|
|
anxiety
Time Frame: at the time of acute infection, average of 1 month
|
Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale.
Scoring:5-9 mild; 10-14 moderate; >15 severe.
Minimum 0, maximum 21 points
|
at the time of acute infection, average of 1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Zainab N Abdul-nabi, M.Sc., University of Basrah
- Study Director: Hiba Dawood, M.Sc., University of Basrah
- Study Director: Qussay N Almaliki, Ph.D., AlFayhaa Teaching hospital
- Study Director: Nadheera F Neamah, University of Basrah
- Principal Investigator: Dania Zydoon, Al-Sader teaching hospital
- Principal Investigator: Zainab Mahdi, Al-Mawani general hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Mood Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Depression
- Depressive Disorder
- COVID-19
- Anxiety Disorders
Other Study ID Numbers
- 1120 (Other Identifier: Ain Shams University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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