- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04344834
Short and Long-term Psychological Impact of Covid-19 on The Egyptians
March 16, 2021 updated by: Gellan Karamalllah Ramadan Ahmed, Assiut University
Psychological Impact of Covid-19 on The Egyptians
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Health care workers and general population will be included in the study. A questionnaire will be used to assess their knowledge and practices regarding covid-19 and its impact on mental health.
Patients Mental health will be assessed regarding anxiety, depression and obsessive compulsive disorder, sleep disorder will be assessed.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt, 71111
- Recruiting
- Faculty of medicine
-
Contact:
- Gellan Ahmed
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Health care workers, patients recovered from COVID-19 and general population
Description
Inclusion Criteria:
- Egyptian population
Exclusion Criteria:
- Patients not accepting to participate in the questionnaire
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Health care workers
Egyptian health care workers
|
A questionnaire or scale to assess the participants mental health.
|
|
General population
Any Egyptian personnel
|
A questionnaire or scale to assess the participants mental health.
|
|
Recovered fromCOVID-19
Patients recovered from COVID-19
|
A questionnaire or scale to assess the participants mental health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Pitsburgh sleep quality index
|
6 months
|
|
Psychological problems
Time Frame: 6 months
|
Symptom checklist 90
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2020
Primary Completion (Anticipated)
March 30, 2021
Study Completion (Anticipated)
June 30, 2021
Study Registration Dates
First Submitted
April 11, 2020
First Submitted That Met QC Criteria
April 13, 2020
First Posted (Actual)
April 14, 2020
Study Record Updates
Last Update Posted (Actual)
March 18, 2021
Last Update Submitted That Met QC Criteria
March 16, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Covid-19 mental health
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Only the data described in the results of the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Health Issue
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Stanford UniversityRecruitingMental Health IssueUnited States
-
The Hong Kong Polytechnic UniversityRecruiting
-
Yale UniversityEmpowerment to Heal - Uganda; Empower Through HealthRecruiting
-
The Hong Kong Polytechnic UniversityRecruiting
-
Hospices Civils de LyonCompleted
-
The Hong Kong Polytechnic UniversityCompleted
-
Limbic LimitedCompletedMental Health IssueUnited Kingdom
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...Completed
-
Wake Forest University Health SciencesThe Duke EndowmentCompletedMental Health IssueUnited States
Clinical Trials on A questionnaire or scales
-
Medipol UniversityCompleted
-
Recep Tayyip Erdogan University Training and Research...CompletedDental Caries in Children | Tooth Loss | Oral HealthTurkey
-
Assistance Publique - Hôpitaux de ParisINSERM, Epopé teamRecruitingPregnancy Complications | Neonatal Complications | covid19 InfectionFrance
-
Fondazione Don Carlo Gnocchi OnlusMinistry of Health, ItalyRecruitingCommunication Disorders | Motor Disorders | Cognitive Disorder | Communication Aids for DisabledItaly
-
Hospices Civils de LyonRecruiting
-
Istituto Ortopedico GaleazziNot yet recruitingImmuNe-Mediated Inflammatory DiseasesItaly
-
Memorial Sloan Kettering Cancer CenterCompletedMelanomaUnited States
-
Nigde Omer Halisdemir UniversityCompletedSleep | Motor Development | Colic, Infantile | Sensory Integration DysfunctionTurkey
-
Medizinische Hochschule Brandenburg Theodor FontaneCompleted
-
Memorial Sloan Kettering Cancer CenterCompletedAdolescent Cancer Survivors | Pediatric Cancer SurvivorsUnited States