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Depression, Anxiety and SARS-CoV-2 (Covid-19) Phobia in Post-stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04560413
Recruitment Status : Completed
First Posted : September 23, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Fatih Sultan Mehmet Training and Research Hospital

Brief 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. 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.


Condition or disease
SARS-CoV-2 Post-stroke Depression Anxiety and Fear

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.

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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Depression, Anxiety and SARS-CoV-2 Phobia in Post-stroke Patients During SARS-CoV-2 Pandemic
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : July 25, 2020
Actual Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Phobias




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post-stroke patients who aged over 18
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560413


Locations
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Turkey
Fatih Sultan Mehmet Training and Research Hospital
İstanbul, Turkey, 34752
Sponsors and Collaborators
Fatih Sultan Mehmet Training and Research Hospital
Investigators
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Principal Investigator: Duygu Silte Karamanlioglu, MD Fatih Sultan Mehmet Training and Research Hospital
Study Chair: Arzu Atici, MD Fatih Sultan Mehmet Training and Research Hospital
Study Chair: Gulcan Ozturk, MD Fatih Sultan Mehmet Training and Research Hospital
Study Director: Pinar Akpinar, Assoc Prof Fatih Sultan Mehmet Training and Research Hospital
Study Chair: Feyza Unlu Ozkan, Assoc Prof Fatih Sultan Mehmet Training and Research Hospital
Study Chair: Ilknur Aktas, Prof Fatih Sultan Mehmet Training and Research Hospital
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Responsible Party: Fatih Sultan Mehmet Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04560413    
Other Study ID Numbers: FSMEAH-KAEK 2020/41
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatih Sultan Mehmet Training and Research Hospital:
Anxiety
Post-stroke Depression
SARS-CoV-2
Phobia
Additional relevant MeSH terms:
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Stroke
Depression
Depressive Disorder
Anxiety Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders