Mental Health IssueNCT04344834
Short and Long-term Psychological Impact of Covid-19 on The Egyptians
An observational study of Mental Health Issue, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- A questionnaire or scales
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Health care workers, patients recovered from COVID-19 and general population
Who may be able to join
- Egyptian population
Who cannot join
- Patients not accepting to participate in the questionnaire
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Asyut, 71111
Gellan Ahmed
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- A questionnaire or scales
- Keywords
- Covid-19, Egyptian, Health workers, population, mental health
- Medical subject headings
- COVID-19, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A questionnaire or scalesDiagnostic test
A questionnaire or scale to assess the participants mental health.
| Study group | Role | What they receive |
|---|---|---|
| Health care workers | Egyptian health care workers Receives: Diagnostic Test: A questionnaire or scales | |
| General population | Any Egyptian personnel Receives: Diagnostic Test: A questionnaire or scales | |
| Recovered fromCOVID-19 | Patients recovered from COVID-19 Receives: Diagnostic Test: A questionnaire or scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Sleep disorder
Pitsburgh sleep quality index
Measured: 6 months
Psychological problems
Symptom checklist 90
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start15 Jun 2020
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gellan Karamalllah Ramadan Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344834
- Sponsor's protocol ID
- Covid-19 mental health
- Status last verified
- Mar 2021
- First submitted
- 11 Apr 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the data described in the results of the study.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of Covid-19 on The Egyptians
- ClinicalTrials.gov ID
- NCT04344834
- Acronym / sponsor ID
- Covid-19 mental health
- Conditions
- Mental Health Issue
- Keywords
- Covid-19, Egyptian, Health workers, population, mental health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health care workers | – | Diagnostic Test: A questionnaire or scalesEgyptian health care workers |
| General population | – | Diagnostic Test: A questionnaire or scalesAny Egyptian personnel |
| Recovered fromCOVID-19 | – | Diagnostic Test: A questionnaire or scalesPatients recovered from COVID-19 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Health care workers, patients recovered from COVID-19 and general population
Key inclusion criteria (1 listed)
- Egyptian population
Key exclusion criteria (1 listed)
- Patients not accepting to participate in the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A questionnaire or scalesA questionnaire or scale to assess the participants mental health. | Diagnostic test | General population, Health care workers, Recovered fromCOVID-19 |
Primary outcome
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.
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.
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.
Sleep disorder
Time frame: 6 months
Pitsburgh sleep quality index
Psychological problems
Time frame: 6 months
Symptom checklist 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No. Only the data described in the results of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gellan Ahmed, Phd (+201093663928, gillankaram@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.