NCT04344834

Brief Summary

The World Health Organization (WHO) has recently declared coronavirus disease 2019 (Covid-19) a public health emergency of international concern. Impact of the pandemic of covid-19 on the mental health of patients, health care workers and general population would be affected.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

April 11, 2020

Last Update Submit

March 16, 2021

Conditions

Keywords

Covid-19EgyptianHealth workerspopulationmental health

Outcome Measures

Primary Outcomes (5)

  • Depression

    Hamilton depression scale:The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe). For the 17-item version, scores can range from 0 to 54.Where total scores between 0 and 7 do not indicate the presence of depression, scores between 8 and 13 indicate mild depression, scores between 14 and 18 indicate moderate depression, scores between 19 and 22 indicate severe depression and 23 score or more indicate very severe depression.

    6 months

  • Anxiety

    Hamilton anxiety scale:The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where total score 0 -13=normal, 14-17 = mild anxiety, 18-24 = moderate anxiety, 25-30 = severe anxiety.

    6 months

  • Obsessive compulsive disorder

    Yale-Brown Obsessive Compulsive Scale (OCD): Each item is rated from 0 (no symptoms) to 4 (extreme symptoms). A score of 0-7 is considered nonclinical. Scores ranging between 8 and 15 are considered mild. Scores between 16 and 23 are considered moderate and scores between 24-31 and 32-40 are considered severe and extreme, respectively.

    6 months

  • Sleep disorder

    Pitsburgh sleep quality index

    6 months

  • Psychological problems

    Symptom checklist 90

    6 months

Study Arms (3)

Health care workers

Egyptian health care workers

Diagnostic Test: A questionnaire or scales

General population

Any Egyptian personnel

Diagnostic Test: A questionnaire or scales

Recovered fromCOVID-19

Patients recovered from COVID-19

Diagnostic Test: A questionnaire or scales

Interventions

A questionnaire or scale to assess the participants mental health.

General populationHealth care workersRecovered fromCOVID-19

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health care workers, patients recovered from COVID-19 and general population

You may qualify if:

  • Egyptian population

You may not qualify if:

  • Patients not accepting to participate in the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19Psychological Well-Being

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

Gellan Ahmed, Phd

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Psychiatry

Study Record Dates

First Submitted

April 11, 2020

First Posted

April 14, 2020

Study Start

June 15, 2020

Primary Completion

March 30, 2021

Study Completion

June 30, 2021

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Only the data described in the results of the study.

Locations