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NCT Number: NCT06278532

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

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.

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Key information

Conditions

Schizophrenia Cognition Disorders Cognitive Deficit Depressive Symptoms Due to Primary Psychotic Disorder (Diagnosis) Disease Mental Disorders Negative Symptoms in Schizophrenia Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jonas Montvidas, Kaunas, Lithuania

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Other names: 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.

Other names: 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.

Other names: SCoRS

Primary outcomes

  1. Validated Lithuanian version of the Brief Negative Symptoms Scale.

    Time frame: Day 1

    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.

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

    Time frame: Day 1

    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.

  3. Validated Lithuanian version of the Schizophrenia Cognition Rating Scale.

    Time frame: Day 1

    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.

Secondary outcomes

  1. Correlation between negative symptoms and cognitive deficits of schizophrenia

    Time frame: Day 1

    Correlation between negative symptoms evaluated with second-generation negative symptoms assessment tools (Brief Negative Symptoms Scale (score 0 - 78; a greater score means more pronounced negative symptoms) and Self-evaluation of Negative Symptoms scale (score 0 - 40; greater score means more pronounced negative symptoms) and 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). Correlations between specific subscales of the Brief Negative Symptoms Scale, the Self-evaluation of Negative Symptoms Scale, and the Schizophrenia Cognition Rating Scale will be calculated. We will check for differences in correlation between different ages, education, duration of disease groups, and sexes.

  2. Correlation between depressive symptoms and cognitive deficits of schizophrenia

    Time frame: Day 1

    Correlation between depressive symptoms evaluated with the Calgary Depression Scale for Schizophrenia (score 0 - 27; a greater score means greater depression) and 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). Correlations between specific items of the Calgary Depression Scale for Schizophrenia and the Schizophrenia Cognition Rating Scale will be calculated. We will check for differences in correlation between different ages, education, duration of disease groups, and sexes.

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

    Time frame: Day 1

    Correlation between results obtained from the Brief Negative Symptoms Scale score 0 - 78; a greater score means more pronounced negative symptoms), Self-evaluation of Negative Symptoms Scale (score 0 - 40; a greater score means more pronounced negative symptoms), Calgary Depression Scale for Schizophrenia (score 0 - 27; a greater score means greater depression), and 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) with results about the health-related quality of life of patients with schizophrenia evaluated with the 36-Item Short Form Survey (8 subscores scored from 0 percent to 100 percent, with more percents meaning better health-related quality of life) will be calculated. We will check for differences in correlation between different ages, education, duration of disease groups, and sexes.

Study contacts

Contact information is provided by the study sponsor or research team.

Algirdas Musneckis, MD

CONTACT

[email protected]

+37061378748

Jonas Montvidas, MD

CONTACT

[email protected]

+37066240919

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

Validation of the Lithuanian Version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and the Schizophrenia Cognition Rating Scale

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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