DepressionNCT04394078
Impact of COVID-19 Pandemic on Depression and Quality of Life
An observational study of Depression and Quality of Life, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic and reveal the relationship between them Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Quality of Life, Covid 19
- What is being tested?
- Online survey
- How many people
- 543 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2020to 18 May 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population of the individuals between 15 - 65 ages in Turkey is 56.391.925 people. It is calculated that there are 42.463.119 individuals cover the criterion as universe of the study.
Who may be able to join
- being Turkish
- understanding Turkish
- currently living in Turkey
- being between the age of 15 - 65
- being literate
- have internet access
Who cannot join
- being diagnosed with a psychological disorder before the pandemic
- having missing value on outcome measures
- giving incomprehensible answering
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of COVID-19 Pandemic on Depression and Quality of Life: Cross Sectional Study on Turkish Society and Suggestions on Potential Solution
It is aimed to investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic and reveal the relationship between them
Read the detailed description
Study hypothesis that people are tend to be depressed and the quality of life is affected negatively by Covid-19 pandemic. Although Turkey has affected moderately, the immediate change on depression and quality of life observable and measurable. It is aimed to investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic and reveal the relationship between them. According to existing data and perspective of psychology and physiotherapy, potential solutions will be aligned.
- Conditions
- Depression, Quality of Life, Covid 19, Social Isolation
- Being tested
- Online survey
- Keywords
- Covid 19, Depression, Quality of Life, Turkish Society, Social Isolation
- Medical subject headings
- Depression, COVID-19, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online surveyOther
Volunteer individuals enrolled the study after approval an online informed consent form. Sociodemographic data of the participants recorded as an online survey. Then, patient reported outcomes were used to assess depression (Zung depression Scale) and quality of life (WHO Qualiy of Life - Bref version).
| Study group | Role | What they receive |
|---|---|---|
| Turkish society | Individuals speak Turkish and lives in Turkey, ages between 15 - 65, literate and with internet access Receives: Other: Online survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic information form
Participants are asked to give information about: age, gender, educational status, height, weight, occupation, working status, city inhabited, whether they live alone or with someone, whether they have a chronic disease, have a pet, do physical activity, eat healthy and sufficient, have qualified sleep, whether they are supported economically.
Measured: two months after Covid 19 recognised as pandemic
Zung Depression Scale
Zung depression scale, developed by Zung (Zung, 1965), is patient rating depression scale, was used to asses four domains related to depression; somatic, mood disorders, psychomotor and psychological disorders. Each question is rated on a 4-point Likert scale (0- never, 1- sometimes, 2- frequently, 3- always). Scale contains 10 straight 10 reverse questions. The total score is calculated from the raw score obtained (total score = (raw score / 80) * 100). Accordingly, scores less than 50 are normal or no psychopathology; between 50 and 59 points indicates mild level, between 60 and 69 points indicate moderate level and 70 and above points indicate severe level depression (Thurber et al., 2002). The validity reliability of the scale was studied on Turkish society (Gencdogan \& Nihal, 2011)
Measured: two months after Covid 19 recognised as pandemic
World Health Organization Quality of Life - Bref
World Health Organization Quality of Life Bref is the short version of the WHOQOL-100 to assess the health-related quality of life (Harper et al., 1998), which has efficient psychometric properties, valid and reliable for Turkish society (Eser et al., 1999). It is essential for epidemiological survey and international report has built for psychometric properties for 26 country where Turkey within (Skevington et al., 2004). It has 4 domains; physical health, psychology, social relations and environment. Each question is answered on a 5-point Likert scale. The raw score is converted into a percentage system. The quality of life is interpreted as good as it gets closer to 100% (Akvardar et al., 2006).
Measured: two months after Covid 19 recognised as pandemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start6 May 2020
- Primary completion18 May 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Yuksek Ihtisas University
- Responsible party
- Principal investigator, Begüm Okudan, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394078
- Sponsor's protocol ID
- 56665618-204.01.07
- Status last verified
- Jun 2020
- First submitted
- 18 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are stored by researches, if needed for scientific purposes, it can be discussed to share .
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Pandemic on Depression and Quality of Life: Cross Sectional Study on Turkish Society and Suggestions on Potential Solution
- ClinicalTrials.gov ID
- NCT04394078
- Acronym / sponsor ID
- 56665618-204.01.07
- Conditions
- Depression, Quality of Life, Covid 19, Social Isolation
- Keywords
- Covid 19, Depression, Quality of Life, Turkish Society, Social Isolation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Yuksek Ihtisas University
- Study start
- 6 May 2020 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 19 May 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.
It is aimed to investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic and reveal the relationship between them
Detailed description
Study hypothesis that people are tend to be depressed and the quality of life is affected negatively by Covid-19 pandemic. Although Turkey has affected moderately, the immediate change on depression and quality of life observable and measurable. It is aimed to investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic and reveal the relationship between them. According to existing data and perspective of psychology and physiotherapy, potential solutions will be aligned.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Turkish society | – | Other: Online surveyIndividuals speak Turkish and lives in Turkey, ages between 15 - 65, literate and with internet access |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population of the individuals between 15 - 65 ages in Turkey is 56.391.925 people. It is calculated that there are 42.463.119 individuals cover the criterion as universe of the study.
Key inclusion criteria (6 listed)
- being Turkish
- understanding Turkish
- currently living in Turkey
- being between the age of 15 - 65
- being literate
Key exclusion criteria (3 listed)
- being diagnosed with a psychological disorder before the pandemic
- having missing value on outcome measures
- giving incomprehensible answering
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 |
|---|---|---|
| Online surveyVolunteer individuals enrolled the study after approval an online informed consent form. Sociodemographic data of the participants recorded as an online survey. Then, patient reported outcomes were used to assess depression (Zung depression Scale) and quality of life (WHO Qualiy of Life - Bref version). | Other | Turkish society |
Primary outcome
Sociodemographic information form
Time frame: two months after Covid 19 recognised as pandemic
Participants are asked to give information about: age, gender, educational status, height, weight, occupation, working status, city inhabited, whether they live alone or with someone, whether they have a chronic disease, have a pet, do physical activity, eat healthy and sufficient, have qualified sleep, whether they are supported economically.
Zung Depression Scale
Time frame: two months after Covid 19 recognised as pandemic
Zung depression scale, developed by Zung (Zung, 1965), is patient rating depression scale, was used to asses four domains related to depression; somatic, mood disorders, psychomotor and psychological disorders. Each question is rated on a 4-point Likert scale (0- never, 1- sometimes, 2- frequently, 3- always). Scale contains 10 straight 10 reverse questions. The total score is calculated from the raw score obtained (total score = (raw score / 80) * 100). Accordingly, scores less than 50 are normal or no psychopathology; between 50 and 59 points indicates mild level, between 60 and 69 points indicate moderate level and 70 and above points indicate severe level depression (Thurber et al., 2002). The validity reliability of the scale was studied on Turkish society (Gencdogan \& Nihal, 2011)
World Health Organization Quality of Life - Bref
Time frame: two months after Covid 19 recognised as pandemic
World Health Organization Quality of Life Bref is the short version of the WHOQOL-100 to assess the health-related quality of life (Harper et al., 1998), which has efficient psychometric properties, valid and reliable for Turkish society (Eser et al., 1999). It is essential for epidemiological survey and international report has built for psychometric properties for 26 country where Turkey within (Skevington et al., 2004). It has 4 domains; physical health, psychology, social relations and environment. Each question is answered on a 5-point Likert scale. The raw score is converted into a percentage system. The quality of life is interpreted as good as it gets closer to 100% (Akvardar et al., 2006).
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 11 Jun 2020.
- Individual participant dataSharing planned: No. Data are stored by researches, if needed for scientific purposes, it can be discussed to share .
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Depression and Quality of Life, run by Okan University at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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 11 Jun 2020. 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 Turkey (Türkiye). 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?
Sociodemographic information form (time frame: two months after Covid 19 recognised as pandemic). The study lists 3 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 11 Jun 2020.