Psychiatric Disturbances and COVID-19 Infection

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04459403
Collaborator
Ministry of Health and Population, Egypt (Other), National Hepatology & Tropical Medicine Research Institute (Other)
400
3
6.7
133.3
19.8

Study Details

Study Description

Brief Summary

This observational study aims at Assessment of the prevalence and types Psychiatric disturbances that affects patients with COVID-19 infection with and without previous psychiatric diseases. in addition to, Assessment of the types of Psychiatric disturbances in patients with COVID-19 infection in correlation to age, disease severity, co-morbid conditions and treatments applied

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    International outbreak of the novel coronavirus (2019- nCoV) raised intense attention of specialists worldwide, including psychiatrists. The five stages of shock-denial, anger, bargaining, depression, and acceptance are experienced by many patients. Coronaphobia is a novel term referring to excessive fear of being infected by coronavirus. The current pandemic necessitates research in different areas of psychiatry, including psychosocial and pharmacological interventions to find evidence-based ways of treatment.

    This is a multi-center observational cross-sectional study with consecutive sample that will include patients quarantined due to COVID-19 infection. Adult Patients will be recruited consecutively (convenient sample). Data will be collected from patients in the form of:

    Demographic data e.g. Age, Gender, Smoking history, exposure to source transmission Co-morbidities e.g. underlying chronic liver, lung, cardiac or kidney diseases, diabetes mellitus, hypertension Severity of COVID-19 infection: mild, moderate or severe

    Psychiatric assessment of patients:
    Patients will be subjected to the following questionnaires:
    1. The General Health Questionnaire (GHQ-12), Arabic version:

    It is the most extensively used screening instrument for common mental disorders, in addition to being a more general measure of psychiatric well-being. It asks whether the respondent has experienced a particular symptom or behavior recently. Each item is rated on a four-point scale (less than usual, no more than usual, rather more than usual, or much more than usual); it gives a total score of 36 based on the Likert scoring styles (0-1-2-3). It is a brief, simple, easy to complete, and its application in research settings as a screening tool is well documented. GHQ-12 is a consistent and reliable instrument when used in general population samples.

    1. Taylor Manifest Anxiety Scale , Arabic version:

    A person answers by reflecting on themselves, in order to determine their anxiety level. It is used to separate normal participants from those who would be considered to have pathological anxiety levels. It consists of 50 true or false questions. It has been proven reliable using test-retest reliability. O'Connor, Lorr, and Stafford found there were five general factors in the scale: chronic anxiety or worry, increased physiological reactivity, sleep disturbances associated with inner strain, sense of personal inadequacy, and motor tension .

    1. Beck Depression Inventory (BDI) , Arabic version:

    It is a self-report scale designed to assess symptoms of depression such as sadness, guilt, loss of interest, social withdrawal, increase and decrease in appetite or sleep, suicidal ideation, and other behavioral manifestations of depression over the previous 2 weeks. It can also be used over time to monitor symptoms and to assess response to therapeutic interventions. The inventory is composed of 21 groups of statements on a four-point scale with the patient selecting the one that best matches his or her current state.

    1. The Brief-COPE scale , Arabic version :

    It is an abbreviated version of the COPE (Coping Orientation to Problems Experienced) Inventory. It is a self-report questionnaire developed to assess a broad range of coping responses. It is one of the best validated and most frequently used measures of coping strategies. The instrument consists of 28 items that measure 14 factors of 2 items each, which correspond to a Likert scale ranged from 0 - 3.

    from each center included in this study there is a person responsible for checking completeness of the collected questionnaires

    Statistical Analysis Results will be evaluated statistically by the Statistical Package for the Social Sciences (SPSS) version 20 (IBM, 2011). Normality of data will be tested by Kolmogorov-Smirnov test. To describe the data, frequency (percent) and meanĀ± SD will be used. T-test and Pearson correlation test will be used for comparisons and correlations respectively for normally distributed data. Mann-Whitney U test and Spearman correlation test will be used for comparisons and correlations respectively for non-normally distributed data. P-values less than 0.05 will be considered statistically significant and 95 % Confidence interval (CI) will be calculated.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    400 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Psychiatric Disturbances in Patients Infected With COVID-19: A Cross Sectional Study
    Actual Study Start Date :
    Jun 8, 2020
    Actual Primary Completion Date :
    Dec 30, 2020
    Actual Study Completion Date :
    Dec 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Psychiatric well-being, level of anxiety, symptoms of depression and coping strategies questionnaire [3 months]

      The General Health Questionnaire: To measure psychiatric well-being. Taylor Manifest Anxiety Scale: To determine the level of anxiety. Beck Depression Inventory: To assess symptoms of depression. The Brief-COPE scale: To assess coping responses. These questionnaires are combined in one questionnaire filled by the patients. it needs from 15-20 minutes.

    2. Prevalence and types of Psychiatric disturbances in patients with COVID-19 infection [3 months]

      prevalence of each type and correlation with age, disease severity, co-morbid conditions and treatments applied

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Confirmed cases with COVID-19 defined as a positive result to real-time reverse-transcriptase polymerase-chain-reaction (RT-PCR) assay for nasal and pharyngeal swab specimens
    Exclusion Criteria:
    • Patients who refuse to be included in the research

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 15 Mayo Smart Hospital Cairo Egypt
    2 National hepatology and tropical medicine research institute Cairo Egypt
    3 Students hospital Giza Egypt

    Sponsors and Collaborators

    • Cairo University
    • Ministry of Health and Population, Egypt
    • National Hepatology & Tropical Medicine Research Institute

    Investigators

    • Principal Investigator: Hend I Shousha, M.D, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hend Ibrahim Shousha, Assistant Professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04459403
    Other Study ID Numbers:
    • 15-2020/1
    First Posted:
    Jul 7, 2020
    Last Update Posted:
    Jan 28, 2021
    Last Verified:
    Jan 1, 2021
    Keywords provided by Hend Ibrahim Shousha, Assistant Professor, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 28, 2021