SARS-CoV-2NCT04560413
Depression, Anxiety and SARS-CoV-2 (Covid-19) Phobia in Post-stroke Patients
An observational study of SARS-CoV-2 and Post-stroke Depression, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has begun, first in Wuhan, China, and then became a pandemic. The first SARS-CoV-2 case in Turkey was reported on March 11, 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2, Post-stroke Depression, Anxiety and Fear
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 10 Aug 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
- No healthy volunteers
- Adult, Older adult
Study population: Post-stroke patients who aged over 18
Who may be able to join
- Aged 18 years old
- Post stroke patients
- Patients with mini mental state examination score above 24
- Patients who don't have aphasia
- Patients who were able to communicate in Turkish on the telephone
Who cannot join
- Patients under the 18 years old
- Patients who do not accept phone calls
- Patients with mini mental state examination score below 24
- Patients who have aphasia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34752
About this study
Official title: Depression, Anxiety and SARS-CoV-2 Phobia in Post-stroke Patients During SARS-CoV-2 Pandemic
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has begun, first in Wuhan, China, and then became a pandemic. The first SARS-CoV-2 case in Turkey was reported on March 11, 2020. People older than 65 years old became subject to lock down measures beginning on March 21, while people younger than 20 years old became subject to lock down measures beginning on April 03. A total lock down has been implemented a few times lasting between 3 to 4 days, especially at weekends. Several studies show that mental health problems could occur in public during the SARS-CoV-2 pandemic.
Depression and anxiety are a commonly known mental health issue in post-stroke patients. This patient population, who usually have to spend most of their time at home, remained completely at home and socially isolated due to the precautions required by the pandemic. Based on the above research evidence; depression, anxiety and phobia of SARS-CoV-2 may increase in the post stroke patients due to being in risk group and effects of measures taken against SARS-CoV-2 pandemic. Therefore, we aimed to assess the depression, anxiety and SARS-CoV-2 phobia in post stroke patients during SARS-CoV-2 outbreak, and to explore the potential influence factors.
Read the detailed description
90 post-stroke patients who meet the working criteria were called by phone. All of them were followed up in the stroke outpatient clinic of the Physical Medicine and Rehabilitation Clinic. Only 77 patients were reached. Permission was asked for questioning from the patients reached. The health and social status of the patients who agreed to participate in the study during the SARS-CoV-2 pandemic period was questioned with the form we prepared. Form template included socio-demographic features, physical, and detailed medical histories. In addition, the fear based on the SARS-CoV-2 virus was examined with the Covid-19 phobia scale (CP19-S), while anxiety and depression were evaluated with the hospital anxiety and depression scale (HADS). Furthermore, Brunnstrom stages, Barthel index and functional ambulation classification (FAC), which was evaluated in the last 6 months, was recorded from the files to explore mobilization of the patients.
The C19P-S is a self-report instrument with a five-point Likert-type scale to assess the levels of SARS-CoV-2 phobia. All items are rated on a 5-point scale from "strongly disagree (1)" to "strongly agree (5)." The scores on the scale can range between 20 and 100 and a higher score indicates a greater phobia in the respected subscales and total scale. In the present study, total scale scores ranged from 20 to 100. The scale examines four main factors: psychological, psycho-somatic, economic and social HADS that includes anxiety and depression subscales. HADS is a self-report scale. It consists of 14 items, 7 of which are depression and 7 of which are symptoms of anxiety. Answers are evaluated in four Likert formats. The cutoff scores of the Turkish form of the HAD scale were determined as 10 for the anxiety subscale and 7 for the depression subscale. The purpose of the scale is not to make a diagnosis, but to determine the risk group by screening anxiety and depression in a short time in those with physical illness.
- Conditions
- SARS-CoV-2, Post-stroke Depression, Anxiety and Fear
- Keywords
- Anxiety, Post-stroke Depression, SARS-CoV-2, Phobia
- Medical subject headings
- Anxiety Disorders, Phobic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale evaluation includes a total of 14 questions (score range 0-3), which are scored to separately estimate anxiety and depressive status (7 questions each). The individual score for the anxiety and depression subscales may vary from 0 to 21. The aim of this scoring system is not to make an objective diagnosis, but to determine the current presence and tendency to anxiety or depression at the time of diagnosis. A HADS score of 8 to 10 is broadly accepted as indicating mild symptoms, a score between 11-16 suggests moderate anxiety or depression, and a score of 16 or more indicates severe anxiety or depressive symptoms
Measured: 3 months
Covid 19 Phobia Scale
The Covid 19 Phobia Scale is a self-report instrument with a five-point Likert-type scale to assess the levels of SARS-CoV-2 phobia. All items are rated on a 5-point scale from "strongly disagree (1)" to "strongly agree (5)." The scores on the scale can range between 20 and 100 and a higher score indicates a greater phobia in the respected subscales and total scale. In the present study total scale scores ranged from 20 to 100. The scale examines four main factors: psychological, psycho-somatic, economic and social
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Jun 2020
- Primary completion25 Jul 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duygu Silte Karamanlioglu, MD, Principal investigator, Fatih Sultan Mehmet Training and Research HospitalArzu Atici, MD, Study chair, Fatih Sultan Mehmet Training and Research HospitalGulcan Ozturk, MD, Study chair, Fatih Sultan Mehmet Training and Research HospitalPinar Akpinar, Assoc Prof, Study director, Fatih Sultan Mehmet Training and Research HospitalFeyza Unlu Ozkan, Assoc Prof, Study chair, Fatih Sultan Mehmet Training and Research HospitalIlknur Aktas, Prof, Study chair, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560413
- Sponsor's protocol ID
- FSMEAH-KAEK 2020/41
- Status last verified
- Sep 2020
- First submitted
- 20 Sep 2020
- Last updated
- 30 Sep 2020
- 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 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression, Anxiety and SARS-CoV-2 Phobia in Post-stroke Patients During SARS-CoV-2 Pandemic
- ClinicalTrials.gov ID
- NCT04560413
- Acronym / sponsor ID
- FSMEAH-KAEK 2020/41
- Conditions
- SARS-CoV-2, Post-stroke Depression, Anxiety and Fear
- Keywords
- Anxiety, Post-stroke Depression, SARS-CoV-2, Phobia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 25 Jul 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 23 Sep 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.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has begun, first in Wuhan, China, and then became a pandemic. The first SARS-CoV-2 case in Turkey was reported on March 11, 2020. People older than 65 years old became subject to lock down measures beginning on March 21, while people younger than 20 years old became subject to lock down measures beginning on April 03. A total lock down has been implemented a few times lasting between 3 to 4 days, especially at weekends. Several studies show that mental health problems could occur in public during the SARS-CoV-2 pandemic.
Depression and anxiety are a commonly known mental health issue in post-stroke patients. This patient population, who usually have to spend most of their time at home, remained completely at home and socially isolated due to the precautions required by the pandemic. Based on the above research evidence; depression, anxiety and phobia of SARS-CoV-2 may increase in the post stroke patients due to being in risk group and effects of measures taken against SARS-CoV-2 pandemic. Therefore, we aimed to assess the depression, anxiety and SARS-CoV-2 phobia in post stroke patients during SARS-CoV-2 outbreak, and to explore the potential influence factors.
Detailed description
90 post-stroke patients who meet the working criteria were called by phone. All of them were followed up in the stroke outpatient clinic of the Physical Medicine and Rehabilitation Clinic. Only 77 patients were reached. Permission was asked for questioning from the patients reached. The health and social status of the patients who agreed to participate in the study during the SARS-CoV-2 pandemic period was questioned with the form we prepared. Form template included socio-demographic features, physical, and detailed medical histories. In addition, the fear based on the SARS-CoV-2 virus was examined with the Covid-19 phobia scale (CP19-S), while anxiety and depression were evaluated with the hospital anxiety and depression scale (HADS). Furthermore, Brunnstrom stages, Barthel index and functional ambulation classification (FAC), which was evaluated in the last 6 months, was recorded from the files to explore mobilization of the patients.
The C19P-S is a self-report instrument with a five-point Likert-type scale to assess the levels of SARS-CoV-2 phobia. All items are rated on a 5-point scale from "strongly disagree (1)" to "strongly agree (5)." The scores on the scale can range between 20 and 100 and a higher score indicates a greater phobia in the respected subscales and total scale. In the present study, total scale scores ranged from 20 to 100. The scale examines four main factors: psychological, psycho-somatic, economic and social HADS that includes anxiety and depression subscales. HADS is a self-report scale. It consists of 14 items, 7 of which are depression and 7 of which are symptoms of anxiety. Answers are evaluated in four Likert formats. The cutoff scores of the Turkish form of the HAD scale were determined as 10 for the anxiety subscale and 7 for the depression subscale. The purpose of the scale is not to make a diagnosis, but to determine the risk group by screening anxiety and depression in a short time in those with physical illness.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-stroke patients who aged over 18
Key inclusion criteria (5 listed)
- Aged 18 years old
- Post stroke patients
- Patients with mini mental state examination score above 24
- Patients who don't have aphasia
- Patients who were able to communicate in Turkish on the telephone
Key exclusion criteria (4 listed)
- Patients under the 18 years old
- Patients who do not accept phone calls
- Patients with mini mental state examination score below 24
- Patients who have aphasia
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
Hospital Anxiety and Depression Scale
Time frame: 3 months
The Hospital Anxiety and Depression Scale evaluation includes a total of 14 questions (score range 0-3), which are scored to separately estimate anxiety and depressive status (7 questions each). The individual score for the anxiety and depression subscales may vary from 0 to 21. The aim of this scoring system is not to make an objective diagnosis, but to determine the current presence and tendency to anxiety or depression at the time of diagnosis. A HADS score of 8 to 10 is broadly accepted as indicating mild symptoms, a score between 11-16 suggests moderate anxiety or depression, and a score of 16 or more indicates severe anxiety or depressive symptoms
Covid 19 Phobia Scale
Time frame: 3 months
The Covid 19 Phobia Scale is a self-report instrument with a five-point Likert-type scale to assess the levels of SARS-CoV-2 phobia. All items are rated on a 5-point scale from "strongly disagree (1)" to "strongly agree (5)." The scores on the scale can range between 20 and 100 and a higher score indicates a greater phobia in the respected subscales and total scale. In the present study total scale scores ranged from 20 to 100. The scale examines four main factors: psychological, psycho-somatic, economic and social
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 30 Sep 2020.
- 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.
Duygu Silte Karamanlioglu, MD principal investigator
Fatih Sultan Mehmet Training and Research Hospital
Arzu Atici, MD study chair
Fatih Sultan Mehmet Training and Research Hospital
Gulcan Ozturk, MD study chair
Fatih Sultan Mehmet Training and Research 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 SARS-CoV-2 and Post-stroke Depression, run by Fatih Sultan Mehmet Training and Research Hospital 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 5 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 30 Sep 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?
Hospital Anxiety and Depression Scale (time frame: 3 months). 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 30 Sep 2020.