AnxietyNCT04698044
Anxiety and Depression Perceived by Individuals With and Without Cancer During the COVID-19 Pandemic Period
An observational study of Anxiety and Depression, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The COVID-19 pandemic has negatively affected individuals not only physiologically but also psychologically. The aim of this study is to examine the anxiety and depression status of cancer patients, individuals with non-cancer chronic diseases and healthy individuals with an online screening questionnaire during the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, Covid19
- What is being tested?
- Hospital Anxiety Depression Scale
- How many people
- 1,107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2020to 25 Jun 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The sample groups were randomly selected from cancer patients, patients with non-cancer chronic diseases and those without any diseases
Who may be able to join
- Cancer patients, patients with non-cancer chronic diseases and those without any diseases
- 18 years or above
- Literate
Who cannot join
- Psychiatric diseases (depression, mania, bipolar disorder, psychosis, obsessive-compulsive disorder, etc.)
- Mental retardation
- Dementia
- Alzheimer's disease were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan Abdülhamid Han Training and Research Hospital
Istanbul, 34660
About this study
Official title: Anxiety and Depression Perceived by Individuals With and Without Cancer During the COVID-19 Pandemic Period: A Population-based Comparative Study
The COVID-19 pandemic has negatively affected individuals not only physiologically but also psychologically. The aim of this study is to examine the anxiety and depression status of cancer patients, individuals with non-cancer chronic diseases and healthy individuals with an online screening questionnaire during the COVID-19 pandemic period.
Read the detailed description
Our aim is to evaluate and compare the anxiety and depression status of cancer patients, individuals with non-chronic chronic diseases and healthy individuals during the COVID-19 period with an online screening program.
A simple random sampling method performed by a computer was used in selecting the participants from 7,000 people whose information was available in the hospital automation system. The computer program enumerates the items in the sampling frame, determines its own random numbers, and presents the selected items to the researcher in writing or digitally (Newman \& Ridenour, 1998).
The sample groups were randomly selected from cancer patients, patients with non-cancer chronic diseases and those without any diseases. The study included individuals who were aged 18 years and above, volunteered to participate in the study and were literate. The diagnoses recorded in the electronic medical records of the patients were examined, and those diagnosed with psychiatric diseases (depression, mania, bipolar disorder, psychosis, obsessive-compulsive disorder, etc.), mental retardation, dementia, and Alzheimer's disease were excluded. In addition, the questionnaire questions include the question of the presence of existing psychiatric and neurological diseases. The patient was excluded from the study also if these diagnoses were reported by the patient. Moreover, the participation of the patient in the study was not allowed in the presence of both cancer and a non-cancer chronic disease. Non-cancer chronic diseases were defined as diabetes mellitus, hypertension, neurological diseases, asthma, chronic obstructive pulmonary disease (COPD), other pulmonary diseases, cardiovascular diseases, and hypothyroidism. Other patients who used chronic medication and/or were followed up for any chronic disease (rheumatic disease, endocrinal disorders, liver disease, kidney diseases) were classified as other chronic diseases. Approval was taken from the University of Health Sciences, XXX Ethics Committee (approval number: 20/133) before the study commenced. The patients were called with phone and confirmed whether they wanted to participate in the study, and their consents were obtained. Individuals who wanted to participate in the study was informed about the purpose of the study, procedure and data privacy, and told that participation was on a voluntary basis, and individuals could leave the research at any time they wanted. Individuals read and signed their consent forms online. The study was conducted in compliance with the "Ethical principles for medical research involving human subjects" of the Helsinki Declaration. All data were collected with Survey Monkey (2005 SurveyMonkey.com), which provides electronic self-control, prevents multiple entries from the same person, and makes it easier to collect and track data (last data entry: 07/06/2020). Confidentiality was guaranteed by completely deactivating electronic records and IP address records.
- Conditions
- Anxiety, Depression, Covid19, Cancer, Chronic Disease
- Being tested
- Hospital Anxiety Depression Scale
- Keywords
- anxiety, depression, covid-19, cancer, chronic disease
- Medical subject headings
- Anxiety Disorders, Depression, COVID-19, Neoplasms, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Anxiety Depression ScaleDiagnostic test
HADS is a self-report questionnaire designed to screen the symptoms of anxiety and depression in individuals with medical diseases other than psychiatric illnessesHADS is a self-report questionnaire designed to screen the symptoms of anxiety and depression in individuals with medical diseases other than psychiatric illnesses The 4-point Likert type scale, which consists of 14 items, has 2 subscales. Each of the HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D) subscales has 7 items. The score given for each question varies between 0 and 3. A high score indicates a high level of anxiety and depression. The responses given to the questions are given certain scores, and as a result, a score of 0-7 refers to a normal level, 8-10 to a level at the limit and 11 and above to a high level (abnormal level).
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Have not chronic disease Receives: Diagnostic Test: Hospital Anxiety Depression Scale | |
| Cancer | Have cancer Receives: Diagnostic Test: Hospital Anxiety Depression Scale | |
| Non-Cancer Crhronic Disease | Have non-cancer chronic disease Receives: Diagnostic Test: Hospital Anxiety Depression Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
HADS
The score of Hospital Anxiety Depression Scale
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start8 May 2020
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Yıldırım Ayaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698044
- Sponsor's protocol ID
- COVFAIROFALL
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and Depression Perceived by Individuals With and Without Cancer During the COVID-19 Pandemic Period: A Population-based Comparative Study
- ClinicalTrials.gov ID
- NCT04698044
- Acronym / sponsor ID
- COVFAIROFALL
- Conditions
- Anxiety, Depression, Covid19, Cancer, Chronic Disease
- Keywords
- anxiety, depression, covid-19, cancer, chronic disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,107 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 6 Jan 2021 (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 has negatively affected individuals not only physiologically but also psychologically. The aim of this study is to examine the anxiety and depression status of cancer patients, individuals with non-cancer chronic diseases and healthy individuals with an online screening questionnaire during the COVID-19 pandemic period.
Detailed description
Our aim is to evaluate and compare the anxiety and depression status of cancer patients, individuals with non-chronic chronic diseases and healthy individuals during the COVID-19 period with an online screening program.
A simple random sampling method performed by a computer was used in selecting the participants from 7,000 people whose information was available in the hospital automation system. The computer program enumerates the items in the sampling frame, determines its own random numbers, and presents the selected items to the researcher in writing or digitally (Newman \& Ridenour, 1998).
The sample groups were randomly selected from cancer patients, patients with non-cancer chronic diseases and those without any diseases. The study included individuals who were aged 18 years and above, volunteered to participate in the study and were literate. The diagnoses recorded in the electronic medical records of the patients were examined, and those diagnosed with psychiatric diseases (depression, mania, bipolar disorder, psychosis, obsessive-compulsive disorder, etc.), mental retardation, dementia, and Alzheimer's disease were excluded. In addition, the questionnaire questions include the question of the presence of existing psychiatric and neurological diseases. The patient was excluded from the study also if these diagnoses were reported by the patient. Moreover, the participation of the patient in the study was not allowed in the presence of both cancer and a non-cancer chronic disease. Non-cancer chronic diseases were defined as diabetes mellitus, hypertension, neurological diseases, asthma, chronic obstructive pulmonary disease (COPD), other pulmonary diseases, cardiovascular diseases, and hypothyroidism. Other patients who used chronic medication and/or were followed up for any chronic disease (rheumatic disease, endocrinal disorders, liver disease, kidney diseases) were classified as other chronic diseases. Approval was taken from the University of Health Sciences, XXX Ethics Committee (approval number: 20/133) before the study commenced. The patients were called with phone and confirmed whether they wanted to participate in the study, and their consents were obtained. Individuals who wanted to participate in the study was informed about the purpose of the study, procedure and data privacy, and told that participation was on a voluntary basis, and individuals could leave the research at any time they wanted. Individuals read and signed their consent forms online. The study was conducted in compliance with the "Ethical principles for medical research involving human subjects" of the Helsinki Declaration. All data were collected with Survey Monkey (2005 SurveyMonkey.com), which provides electronic self-control, prevents multiple entries from the same person, and makes it easier to collect and track data (last data entry: 07/06/2020). Confidentiality was guaranteed by completely deactivating electronic records and IP address records.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: Hospital Anxiety Depression ScaleHave not chronic disease |
| Cancer | – | Diagnostic Test: Hospital Anxiety Depression ScaleHave cancer |
| Non-Cancer Crhronic Disease | – | Diagnostic Test: Hospital Anxiety Depression ScaleHave non-cancer chronic disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The sample groups were randomly selected from cancer patients, patients with non-cancer chronic diseases and those without any diseases
Key inclusion criteria (3 listed)
- Cancer patients, patients with non-cancer chronic diseases and those without any diseases
- 18 years or above
- Literate
Key exclusion criteria (4 listed)
- Psychiatric diseases (depression, mania, bipolar disorder, psychosis, obsessive-compulsive disorder, etc.)
- Mental retardation
- Dementia
- Alzheimer's disease were excluded.
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 |
|---|---|---|
| Hospital Anxiety Depression ScaleHADS is a self-report questionnaire designed to screen the symptoms of anxiety and depression in individuals with medical diseases other than psychiatric illnessesHADS is a self-report questionnaire designed to screen the symptoms of anxiety and depression in individuals with medical diseases other than psychiatric illnesses The 4-point Likert type scale, which consists of 14 items, has 2 subscales. Each of the HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D) subscales has 7 items. The score given for each question varies between 0 and 3. A high score indicates a high level of anxiety and depression. The responses given to the questions are given certain scores, and as a result, a score of 0-7 refers to a normal level, 8-10 to a level at the limit and 11 and above to a high level (abnormal level). | Diagnostic test | Cancer, Healthy, Non-Cancer Crhronic Disease |
Primary outcome
HADS
Time frame: 14 days
The score of Hospital Anxiety Depression Scale
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 7 Jan 2021.
- Individual participant dataSharing planned: No
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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 Anxiety and Depression, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 3 inclusion and 4 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 7 Jan 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 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?
HADS (time frame: 14 days). 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 7 Jan 2021.