Validation of the Lithuanian Version of the BNSS, CDSS, and the SCoRS

NCT06278532 | Recruiting

• 1 other identifier: NEGKOG
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (3)

• Validated Lithuanian version of the Brief Negative Symptoms Scale.

  Patients will be evaluated using the Lithuanian version of the Brief Negative Symptoms Scale (score 0 - 78; a greater score means more pronounced negative symptoms) once during the inpatient treatment. The results will be compared with the Positive and Negative Symptoms Scale score (0 - 210; a greater score means more pronounced symptoms of schizophrenia), Montgomery Asperger Depression Scale (Score 0 - 60; a greater score means greater symptoms of depression), Self-evaluation of Negative Symptoms Scale (score 0 - 40; greater score means more pronounced negative symptoms), and Montreal Cognitive Assessment Test (score 0 - 31; a greater score means better cognitive functions). Convergent and divergent validities will be calculated for each validated instrument by calculating correlations.

  Day 1

• Validated Lithuanian version of the Calgary Depression Scale for Schizophrenia.

  Patients will be evaluated using the Lithuanian version of the Calgary Depression Scale for Schizophrenia (score 0 - 27; a greater score means greater depression) once during the inpatient treatment, and the results will be compared with results from the Positive and Negative Symptoms Scale (score 0 - 210, greater score means more pronounced symptoms of schizophrenia), Montgomery Asperger Depression Scale (Score 0 - 60; greater score means greater symptoms of depression), and Self-evaluation of Negative Symptoms Scale (score 0 - 40; greater score means more pronounced negative symptoms). Convergent and divergent validities will be calculated for each validated instrument by calculating correlations.

  Day 1

• Validated Lithuanian version of the Schizophrenia Cognition Rating Scale.

  Patients will be evaluated using the Lithuanian version of the Schizophrenia Cognition Rating Scale (score 0 - 80; a greater score means worse cognitive functions; global functioning score 1 - 10 with a greater score meaning worse functioning) once during the inpatient treatment, and the results will be compared with results from the Montreal Cognitive Assessment Test (score 0 - 31; a greater score means better cognitive functions). Convergent and divergent validities will be calculated for each validated instrument by calculating correlations.

  Day 1

Secondary Outcomes (3)

• Correlation between negative symptoms and cognitive deficits of schizophrenia

  Day 1

• Correlation between depressive symptoms and cognitive deficits of schizophrenia

  Day 1

• Correlation between negative symptoms, cognitive deficits, depressive symptoms of schizophrenia and health-related quality of life

  Day 1

Interventions

Brief Negative Symptoms Scale DIAGNOSTIC_TEST

The Lithuanian Brief Negative Symptoms scale (BNSS) version will be used and validated. BNSS is used as a modern tool for the evaluation of negative symptoms of schizophrenia. Older tools used for negative symptoms evaluation often include symptoms from other dimensions of symptoms of schizophrenia, and BNSS evaluates negative symptoms specifically. BNSS is a semi-structured interview made of 13 items. There are six subscales: anhedonia (3 items), lack of normal distress (1 item), asociality (2 items), avolition (2 items), blunted affect (3 items) and alogia (2 items).

Also known as: BNSS

The Calgary Depression Scale for Schizophrenia DIAGNOSTIC_TEST

The Lithuanian version of the CDSS will be used and validated. CDSS is a tool used to evaluate depressive symptoms, specifically for patients with schizophrenia. Often, distinguishing between depressive and negative symptoms of schizophrenia is difficult. Therefore, it is recommended to use tools designed specifically for patients with schizophrenia. CDSS is the only depression scale designed to assess depression in people with a schizophrenia syndrome disorder. It is a semi-structured interview consisting of 9 items.

Also known as: CDSS

The Schizophrenia Cognition Rating Scale DIAGNOSTIC_TEST

The Lithuanian version of the SCoRS will be used and validated. SCoRS is a 20-item interview-based assessment tool that evaluates cognitive deficits and the degree to which these deficits impair specifically in patients with schizophrenia.

Also known as: SCoRS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (2)

Lithuanian University of Health Sciences Hospital Kaunas Clinics

Kaunas, LT-50161, Lithuania

RECRUITING

Jonas Montvidas

Kaunas, LT-53137, Lithuania

RECRUITING

Related Publications (3)

• 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.

  PMID: 20558531 BACKGROUND

• 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.

  PMID: 25028065 BACKGROUND

• 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.

  PMID: 16040126 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Disease; Cognition Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Study Officials

• Virginija Adomaitienė, Prof.

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Montvidas, MD

CONTACT

+37066240919; jonas.montvidas@lsmu.lt

Algirdas Musneckis, MD

CONTACT

+37061378748; algirdas.musneckis@kaunoklinikos.lt

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Psychiatry Department

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 26, 2024
• Study Start: December 11, 2023
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): December 11, 2026
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

LI (2)