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

NCT ID: NCT06278532

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-11

Study Completion Date

2026-12-11

Brief Summary

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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

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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.

Conditions

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Schizophrenia Negative Symptoms in Schizophrenia Depressive Symptoms Due to Primary Psychotic Disorder (Diagnosis) Cognitive Deficit

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Brief Negative Symptoms Scale

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).

Intervention Type DIAGNOSTIC_TEST

The Calgary Depression Scale for Schizophrenia

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.

Intervention Type DIAGNOSTIC_TEST

The Schizophrenia Cognition Rating Scale

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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BNSS CDSS SCoRS

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lithuanian University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Virginija Adomaitienė

Head of Psychiatry Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virginija Adomaitienė, Prof.

Role: PRINCIPAL_INVESTIGATOR

Lithuanian University of Health Sciences

Locations

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Lithuanian University of Health Sciences Hospital Kaunas Clinics

Kaunas, , Lithuania

Site Status RECRUITING

Jonas Montvidas

Kaunas, , Lithuania

Site Status RECRUITING

Countries

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Lithuania

Central Contacts

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Jonas Montvidas, MD

Role: CONTACT

+37066240919

Algirdas Musneckis, MD

Role: CONTACT

+37061378748

Facility Contacts

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Jonas Montvidas

Role: primary

+37066240919

Eimantas Zauka

Role: backup

+37069220076

Jonas Montvidas

Role: primary

+37066240919

Algirdas Musneckis

Role: backup

+37061378748

References

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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.

Reference Type BACKGROUND
PMID: 20558531 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25028065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16040126 (View on PubMed)

Other Identifiers

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NEGKOG

Identifier Type: -

Identifier Source: org_study_id

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