NCT04459403

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

June 8, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

July 2, 2020

Last Update Submit

January 26, 2021

Conditions

Keywords

COVID-19Psychiatric disturbancesEgypt

Outcome Measures

Primary Outcomes (2)

  • Psychiatric well-being, level of anxiety, symptoms of depression and coping strategies questionnaire

    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.

    3 months

  • Prevalence and types of Psychiatric disturbances in patients with COVID-19 infection

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

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with confirmed COVID-19 infection by real time PCR quarantined at isolation hospitals of the Egyptian Ministry of health and population

You may qualify if:

  • 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

You may not qualify if:

  • Patients who refuse to be included in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

15 Mayo Smart Hospital

Cairo, Egypt

Location

National hepatology and tropical medicine research institute

Cairo, Egypt

Location

Students hospital

Giza, Egypt

Location

Related Publications (11)

  • Asmundson GJG, Taylor S. Coronaphobia: Fear and the 2019-nCoV outbreak. J Anxiety Disord. 2020 Mar;70:102196. doi: 10.1016/j.janxdis.2020.102196. Epub 2020 Feb 10. No abstract available.

    PMID: 32078967BACKGROUND
  • Huang Y, Zhao N. Generalized anxiety disorder, depressive symptoms and sleep quality during COVID-19 outbreak in China: a web-based cross-sectional survey. Psychiatry Res. 2020 Jun;288:112954. doi: 10.1016/j.psychres.2020.112954. Epub 2020 Apr 12.

    PMID: 32325383BACKGROUND
  • Daradkeh TK, Ghubash R, el-Rufaie OE. Reliability, validity, and factor structure of the Arabic version of the 12-item General Health Questionnaire. Psychol Rep. 2001 Aug;89(1):85-94. doi: 10.2466/pr0.2001.89.1.85.

    PMID: 11729557BACKGROUND
  • Pevalin DJ. Multiple applications of the GHQ-12 in a general population sample: an investigation of long-term retest effects. Soc Psychiatry Psychiatr Epidemiol. 2000 Nov;35(11):508-12. doi: 10.1007/s001270050272.

    PMID: 11197926BACKGROUND
  • TAYLOR JA. A personality scale of manifest anxiety. J Abnorm Psychol. 1953 Apr;48(2):285-90. doi: 10.1037/h0056264. No abstract available.

    PMID: 13052352BACKGROUND
  • Fahmi M, Ghali M. Arabic version of Taylor Manifest Anxiety Scale. Egypt Psychiatr 1997; 11:119-126

    BACKGROUND
  • Nawel H, Elisabeth S. Adaptation and validation of the Tunisian version of the Brief COPE Scale. Eur Health Psychol. 2015; 17: 783

    BACKGROUND
  • Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available.

    PMID: 31986257BACKGROUND
  • Yoo JH. The Fight against the 2019-nCoV Outbreak: an Arduous March Has Just Begun. J Korean Med Sci. 2020 Feb 3;35(4):e56. doi: 10.3346/jkms.2020.35.e56. No abstract available.

    PMID: 31997618BACKGROUND
  • Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

    PMID: 31986264BACKGROUND
  • Xu J, Zheng Y, Wang M, Zhao J, Zhan Q, Fu M, Wang Q, Xiao J, Cheng Y. Predictors of symptoms of posttraumatic stress in Chinese university students during the 2009 H1N1 influenza pandemic. Med Sci Monit. 2011 Jul;17(7):PH60-4. doi: 10.12659/msm.881836.

    PMID: 21709644BACKGROUND

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19Mental Disorders

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hend I Shousha, M.D

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 7, 2020

Study Start

June 8, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations