Clinical trial NCT04560413: Depression, Anxiety and SARS-CoV-2 (Covid-19) Phobia in Post-stroke Patients
Official title: Depression, Anxiety and SARS-CoV-2 Phobia in Post-stroke Patients During SARS-CoV-2 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
Post-stroke Depression
Anxiety and Fear
Keywords: Anxiety
Post-stroke Depression
SARS-CoV-2
Phobia
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-stroke patients who aged over 18

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.

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.

Eligibility 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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 3 months
measure: Covid 19 Phobia Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Fatih Sultan Mehmet Training and Research Hospital
Study officials:
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Duygu Silte Karamanlioglu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Arzu Atici, MD
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Gulcan Ozturk, MD
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Pinar Akpinar, Assoc Prof
role: STUDY_DIRECTOR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Feyza Unlu Ozkan, Assoc Prof
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Ilknur Aktas, Prof
role: STUDY_CHAIR
References: