SchizophreniaNCT05109572
The Impact of the Covid-19 Pandemic on Schizophrenia Patients Registered With the Community Mental Health Center
An observational study of Schizophrenia, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Hospitalized, Non-hospitalized with emergency care and Non-hospitalized and non-emergency care
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2021to 20 Jul 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: receiving service and having been diagnosed with schizophrenia for at least two years by psychiatry who works from Kartal Dr. Lütfi Kırdar City Hospital Adatepe CMHC
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr Lütfi Kırdar Şehir Hastanesi
Istanbul
About this study
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.
Read the detailed 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.
- Conditions
- Schizophrenia
- Being tested
- Hospitalized, Non-hospitalized with emergency care, Non-hospitalized and non-emergency care
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HospitalizedOther
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 careOther
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 careOther
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".
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized group | Hospitalized patient (HP) stayed in hospital during the Covid-19 pandemic period Receives: Other: Non-hospitalized with emergency care; Other: Non-hospitalized and non-emergency care | |
| Non-hospitalized with Emergency care | Emergency care plan made but no hospitalization was included to this study during the Covid-19 pandemic period Receives: Other: Hospitalized; Other: Non-hospitalized and non-emergency care | |
| 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 Receives: Other: Hospitalized |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 6 months
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 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".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start20 Mar 2021
- Primary completion20 May 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İsmail Koç, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109572
- Sponsor's protocol ID
- 514/194/41
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Covid-19 Pandemic on Schizophrenia Patients Registered With the Community Mental Health Center
- ClinicalTrials.gov ID
- NCT05109572
- Acronym / sponsor ID
- 514/194/41
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 5 Nov 2021 (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.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hospitalized group | – | Other: Non-hospitalized with emergency care, Other: Non-hospitalized and non-emergency careHospitalized patient (HP) stayed in hospital during the Covid-19 pandemic period |
| Non-hospitalized with Emergency care | – | Other: Hospitalized, Other: Non-hospitalized and non-emergency careEmergency care plan made but no hospitalization was included to this study during the Covid-19 pandemic period |
| Non-hospitalized and non-emergency care | – | Other: HospitalizedPatients who neither apply to the emergency department nor are hospitalized was included to this study during the Covid-19 pandemic period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- receiving service and having been diagnosed with schizophrenia for at least two years by psychiatry who works from Kartal Dr. Lütfi Kırdar City Hospital Adatepe CMHC
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HospitalizedIt 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. | Other | Non-hospitalized and non-emergency care, Non-hospitalized with Emergency care |
| Non-hospitalized with emergency careIt 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. | Other | Hospitalized group |
| Non-hospitalized and non-emergency careDeveloped 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". | Other | Hospitalized group, Non-hospitalized with Emergency care |
Primary outcome
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.
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.
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".
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 5 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Schizophrenia, run by Dr. Lutfi Kirdar Kartal 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 7 inclusion and 3 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 5 Nov 2021. 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?
Calgary Depression Scale in Schizophrenia (time frame: 6 months). The study lists 3 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 5 Nov 2021.