- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05109572
The Impact of the Covid-19 Pandemic on Schizophrenia Patients Registered With the Community Mental Health Center
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
İstanbul, Turkey
- Kartal Dr Lütfi Kırdar Şehir Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- between the ages of 18-65,
- receiving service from Kartal Dr. Lütfi Kırdar 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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hospitalized group
Hospitalized patient (HP) stayed in hospital during the Covid-19 pandemic period
|
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.
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 Atlı 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".
|
|
Non-hospitalized with Emergency care
Emergency care plan made but no hospitalization was included to this study during the Covid-19 pandemic period
|
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 Atlı 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".
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 and non-emergency care
Patients who neither apply to the emergency department nor are hospitalized was included to this study during the Covid-19 pandemic period
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Calgary Depression Scale in Schizophrenia
Time Frame: 6 months
|
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
|
|
Buss-perry Aggression Questionnaire
Time Frame: 6 months
|
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
|
|
Suicide Probability Scale
Time Frame: 6 months
|
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 Atlı 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Schizophrenia Spectrum and Other Psychotic Disorders
- COVID-19
- Schizophrenia
Other Study ID Numbers
- 514/194/41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.