AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04698044
Study groupRoleWhat they receive
HealthyHave not chronic disease
Receives: Diagnostic Test: Hospital Anxiety Depression Scale
CancerHave cancer
Receives: Diagnostic Test: Hospital Anxiety Depression Scale
Non-Cancer Crhronic DiseaseHave 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.

  1. 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.

  1. First posted6 Jan 2021
  2. Study start8 May 2020
  3. Primary completion25 Jun 2020
  4. Study completion25 Jun 2020

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in