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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05109572
Other study ID # 514/194/41
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2021
Est. completion date July 20, 2021

Study information

Verified date November 2021
Source Dr. Lutfi Kirdar Kartal Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aimed to examine the effect of the Covid-19 pandemic on schizophrenia patients registered to the Community Mental Health Center (CMHC) in terms of depression, suicide risk, and tendency to violence.


Description:

The study was conducted on patients registered to the Ministry of Health Kartal Dr. Lütfi Kırdar City Hospital Adatepe Community Mental Health Center and was followed up regularly. It was carried out on 108 individuals who met the diagnosis of schizophrenia according to the DSM-V (American Psychiatric Association 2013) and met the inclusion criteria. Individuals who were respectively classified as hospitalized group (HG) during the Covid-19 pandemic period (n=39), non-hospitalized with emergency care group (NHECG) without hospitalization (n=37), and non-hospitalized with non-emergency care group (NHNECG) (n=32). Individuals who had been diagnosed with schizophrenia for at least two years, were not in the active phase of the disease, did not have organic mental disorders, did not have any other psychiatric diseases were included in the study. In the study, the Socio-Demographic Questionnaire, the Calgary Depression Scale in Schizophrenia (CDSS), the Buss-perry Aggression Questionnaire (BPAQ), and the Suicide Probability Scale (SPS) were used.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date July 20, 2021
Est. primary completion date May 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - between the ages of 18-65, - receiving service from Kartal Dr. Lütfi Kirdar City Hospital Adatepe CMHC, - having been diagnosed with schizophrenia for at least two years, - not being in the active phase of the disease, - not having an organic mental disorder, - not having an additional psychiatric illness, and - being literate Exclusion Criteria: - Individuals with cognitive and physical dysfunction, - mental retardation, different psychiatric diseases that would prevent interview or testing, and - those who did not consent to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hospitalized
It was developed by Addington et al. (1994) to measure the presence of depression and the severity of depressive symptoms in patients with schizophrenia. The scale consists of 9 items to assess depression and is answered with a four-point Likert scale. The validity and reliability of the scale in schizophrenia patients in the Turkish population was determined by Oksay et al. by (2000). In the reliability study, the Cronbach's alpha coefficient was found to be 0.88. The cut-off point of the scale was stated as 11.
Non-hospitalized with emergency care
It is adapted from the Buss-Durkee Hostility Inventory by Buss and Perry (1992), the scale consists of 29 items and five-point Likert types. The scale is physical and verbal aggression, hostility, and anger. Questions 9 and 16 on the scale are reverse scored. The score value on the scale varies in direct proportion to the aggression, that is, the higher the score, the higher the aggression. The Cronbach Alpha internal consistency coefficients of the original version of the scale is defined as; 0.89 for physical aggression, 0.85 for physical aggression, 0.72 for verbal aggression, 0.77 for hostility, 0.83 for anger subscale.
Non-hospitalized and non-emergency care
Developed by Cull and Gill (1989), it evaluates the probability of suicide in adolescents and adults. The Turkish validity and reliability of the scale were performed by Atli et al (2009). The scale consists of 36 items and is answered as a four-point Likert-type scale as "never or rarely", "sometimes", "often" and "often or always".

Locations

Country Name City State
Turkey Kartal Dr Lütfi Kirdar Sehir Hastanesi Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Calgary Depression Scale in Schizophrenia It was developed by Addington et al. (1994) to measure the presence of depression and the severity of depressive symptoms in patients with schizophrenia. 19 The scale consists of 9 items to assess depression and is answered with a four-point Likert scale.The validity and reliability of the scale in
schizophrenia patients in the Turkish population was determined by Oksay et al. by (2000). In the reliability study, the Cronbach's alpha coefficient was found to be 0.88. The cut-off point of the scale was stated as 11.
6 months
Primary Buss-perry Aggression Questionnaire It is adapted from the Buss-Durkee Hostility Inventory by Buss and Perry (1992), the scale consists of 29 items and five-point Likert types. 21 The scale is physical and verbal aggression, hostility, and anger. Questions 9 and 16 on the scale are reverse scored. The score value on the scale varies in direct proportion to the aggression, that is, the higher the score, the higher the aggression. The Cronbach Alpha internal consistency coefficients of the original version of the scale is defined as; 0.89 for physical aggression, 0.85 for physical aggression, 0.72 for verbal aggression, 0.77 for hostility, 0.83 for anger subscale. 6 months
Primary Suicide Probability Scale Developed by Cull and Gill (1989), it evaluates the probability of suicide in adolescents and adults. The Turkish validity and reliability of the scale were performed by Atli et al (2009). The scale consists of 36 items and is answered as a four-point Likert-type scale as "never or rarely", "sometimes", "often" and "often or always". 6 months
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