Covid19NCT04689464
COVID 19 and Psychological Health: a Cross Sectional Study to Evaluate Anxiety and Depression in Covid-19 Patients
An observational study of Covid19 and Anxiety, run by Alhasan Mujtaba Al-Mudhaffer at 1 site in Iraq.
Trial summary
The covid-19 pandemic started to spread worldwide since December 2019. It promoted to an exaggerated psychological stress and anxiety in humans due to the intolerable symptoms higher than usual death of many infected patients. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Covid19, Anxiety, Depression
- How many people
- 450 participants
- Where
- 1 siteIraq
- Study dates
- 1 Dec 2020to 1 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with covid19 diagnosed by their healthcare providers
Who may be able to join
- patients with COVID19 willing to participate in the study
Who cannot join
- unwilling unable to read or interact with standardized questionnaire unconscious
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID19 and Psychological Health: a Cross Sectional Evaluation of the Risks of Anxiety and Depression Among Patients Diagnosed With Covid 19
The covid-19 pandemic started to spread worldwide since December 2019. It promoted to an exaggerated psychological stress and anxiety in humans due to the intolerable symptoms higher than usual death of many infected patients. This study examines the corona related anxiety and if there is need for drug intervention to treat this anxiety.
To answer these questions, a survey made to the hospitalized patients including sex, age, educational level, Marital state, and a standardized questionnaires (GAD-7 and PHQ-9) which has been validated and shown to possess good psychometric qualities in studies of participants from multiple populations.
- Conditions
- Covid19, Anxiety, Depression
- Keywords
- COVID19, Anxiety, Depression
- Medical subject headings
- COVID-19, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mild covid | Not described | |
| moderate covid | Not described | |
| severe covid | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression
Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; >20 severe. Minimum 0 maximum 27 points
Measured: at the time of acute infection, average of 1 month
anxiety
Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; >15 severe. Minimum 0, maximum 21 points
Measured: at the time of acute infection, average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Dec 2020
- Primary completion28 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alhasan Mujtaba Al-Mudhaffer
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basrah, Ministry of Health, Iraq
- Responsible party
- Sponsor-investigator, Alhasan Mujtaba Al-Mudhaffer, AlFayhaa General Hospital
- Investigators
- Zainab N Abdul-nabi, M.Sc., Study director, University of BasrahHiba Dawood, M.Sc., Study director, University of BasrahQussay N Almaliki, Ph.D., Study director, AlFayhaa teaching hospitalNadheera F Neamah, Study director, University of BasrahDania Zydoon, Principal investigator, Al-Sader teaching hospitalZainab Mahdi, Principal investigator, Al-Mawani general hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689464
- Sponsor's protocol ID
- 1120
- Status last verified
- Jun 2021
- First submitted
- 26 Dec 2020
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID19 and Psychological Health: a Cross Sectional Evaluation of the Risks of Anxiety and Depression Among Patients Diagnosed With Covid 19
- ClinicalTrials.gov ID
- NCT04689464
- Acronym / sponsor ID
- 1120
- Conditions
- Covid19, Anxiety, Depression
- Keywords
- COVID19, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Alhasan Mujtaba Al-MudhafferUniversity, hospital or other
- Collaborators
- University of Basrah, Ministry of Health, Iraq
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 30 Dec 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 covid-19 pandemic started to spread worldwide since December 2019. It promoted to an exaggerated psychological stress and anxiety in humans due to the intolerable symptoms higher than usual death of many infected patients. This study examines the corona related anxiety and if there is need for drug intervention to treat this anxiety.
To answer these questions, a survey made to the hospitalized patients including sex, age, educational level, Marital state, and a standardized questionnaires (GAD-7 and PHQ-9) which has been validated and shown to possess good psychometric qualities in studies of participants from multiple populations.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild covid | – | – |
| moderate covid | – | – |
| severe covid | – | – |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with covid19 diagnosed by their healthcare providers
Key inclusion criteria (1 listed)
- patients with COVID19 willing to participate in the study
Key exclusion criteria (1 listed)
- unwilling unable to read or interact with standardized questionnaire unconscious
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
depression
Time frame: at the time of acute infection, average of 1 month
Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; >20 severe. Minimum 0 maximum 27 points
anxiety
Time frame: at the time of acute infection, average of 1 month
Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; >15 severe. Minimum 0, maximum 21 points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Zainab N Abdul-nabi, M.Sc. study director
University of Basrah
Hiba Dawood, M.Sc. study director
University of Basrah
Qussay N Almaliki, Ph.D. study director
AlFayhaa teaching hospital
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 Covid19 and Anxiety, run by Alhasan Mujtaba Al-Mudhaffer at 1 site in Iraq.
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: finished, as of the sponsor's last update on 8 Jun 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 Iraq. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depression (time frame: at the time of acute infection, average of 1 month). The study lists 2 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 8 Jun 2021.