Clinical trial NCT06278532: Validation of the Lithuanian Version of the BNSS, CDSS, and the SCoRS
Official title: Validation of the Lithuanian Version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and the Schizophrenia Cognition Rating Scale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia
Negative Symptoms in Schizophrenia
Depressive Symptoms Due to Primary Psychotic Disorder (Diagnosis)
Cognitive Deficit
Keywords: Schizophrenia, Negative symptoms, Depressive symptoms of Schizophrenia, Cognitive deficits of Schizophrenia
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients between 18 and 65 years old with a diagnosis of F20, F25, or F21, according to ICD-10, who sign the informed consent form and do not have any exclusion criteria, will be included in the study. We will not devide patients who have active psychotic symptoms and those who do not.

Brief summary: This study aims to validate the Lithuanian version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale in a Lithuanian sample. This will be done by comparing results obtained from the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale with results obtained from the Positive and Negative Symptoms Scale, the Montgomery Asberg Depression Rating Scale, and the Montreal Cognitive Assessment test.

Detailed description: This scale validation study aims to validate the Lithuanian version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale Schizophrenia Cognition Rating Scale in the Lithuanian sample. The main aim of this study is:

• to evaluate the convergent and discriminant validity of Lithuanian versions of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale.

Participants will be evaluated using the Positive and Negative Symptoms Scale (PANSS), Montgomery Asberg Depression Rating Scale (MADRS), Montreal Cognitive Assessment (MoCA) test, Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale.

To discern the discriminant validity of the Brief Negative Symptoms Scale for negative symptoms, results from the Brief Negative Symptoms Scale will be compared to results from the positive and general subscale of the Positive and Negative Symptoms Scale and the Montgomery Asperger Depression Rating Scale. To discern the convergent validity of the Brief Negative Symptoms Scale for negative symptoms, results from the Brief Negative Symptoms Scale will be compared to the results from the negative subscale of the Positive and Negative Symptoms Scale and the Self-evaluation of Negative Symptoms scale.

To discern the discriminant validity of the Calgary Depression Scale for Schizophrenia for depressive symptoms of schizophrenia, results obtained from the Calgary Depression Scale for Schizophrenia will be compared to results obtained from the Positive and Negative Symptoms Scale and the Self-evaluation of Negative Symptoms scale. To check the convergent validity of the Calgary Depression Scale for Schizophrenia, results obtained from the Calgary Depression Scale for Schizophrenia will be compared to results obtained from the Montgomery Asperger Depression Rating Scale.

Finally, to check the discriminant validity of the Schizophrenia Cognition Rating Scale, results obtained from the Schizophrenia Cognition Rating Scale will be compared to results obtained from the Montgomery Asperger Depression Rating Scale and the Positive and Negative Symptoms Scale. In contrast, to prevent convergent validity, results obtained from the Schizophrenia Cognition Rating Scale will be compared to results obtained from the Montreal Cognitive Assessment test.

Eligibility criteria: Inclusion Criteria:

* age 18 - 65 years old;
* Diagnosis of F20, F25 or F21 according to ICD-10;
* Signed informed consent form.

Exclusion Criteria:

* Age younger than 18 or older than 65 years old;
* Did not sign the informed consent form;
* Legally inactive person
* Patients with a comorbid or primary diagnosis of mental retardation according to ICD-10 (F70 - F79);
* Patients with a comorbid or primary diagnosis of mental and behavioural disorders due to psychoactive substance use (F10 - F19)
* Patients with a comorbid of primary diagnosis of organic, including symptomatic, mental disorders (F00 - F09)

Primary outcomes:
measure: Validated Lithuanian version of the Brief Negative Symptoms Scale.
timeFrame: Day 1
measure: Validated Lithuanian version of the Calgary Depression Scale for Schizophrenia.
timeFrame: Day 1
measure: Validated Lithuanian version of the Schizophrenia Cognition Rating Scale.
timeFrame: Day 1
Secondary outcomes:
measure: Correlation between negative symptoms and cognitive deficits of schizophrenia
timeFrame: Day 1
measure: Correlation between depressive symptoms and cognitive deficits of schizophrenia
timeFrame: Day 1
measure: Correlation between negative symptoms, cognitive deficits, depressive symptoms of schizophrenia and health-related quality of life
timeFrame: Day 1
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences Hospital Kaunas Clinics
city: Kaunas
country: Lithuania
facility: Jonas Montvidas
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Virginija Adomaitienė, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirkpatrick B, Strauss GP, Nguyen L, Fischer BA, Daniel DG, Cienfuegos A, Marder SR. The brief negative symptom scale: psychometric properties. Schizophr Bull. 2011 Mar;37(2):300-5. doi: 10.1093/schbul/sbq059. Epub 2010 Jun 17.
citation: Keefe RS, Davis VG, Spagnola NB, Hilt D, Dgetluck N, Ruse S, Patterson TD, Narasimhan M, Harvey PD. Reliability, validity and treatment sensitivity of the Schizophrenia Cognition Rating Scale. Eur Neuropsychopharmacol. 2015 Feb;25(2):176-84. doi: 10.1016/j.euroneuro.2014.06.009. Epub 2014 Jun 28.
citation: Muller MJ, Brening H, Gensch C, Klinga J, Kienzle B, Muller KM. The Calgary Depression Rating Scale for schizophrenia in a healthy control group: psychometric properties and reference values. J Affect Disord. 2005 Sep;88(1):69-74. doi: 10.1016/j.jad.2005.04.005.