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Active, Not Recruiting

NCT Number: NCT05843357

PAPSY - Memory in Psychiatry

Memory in Psychiatry project (PAPSY) aims to map the distribution and severity of cognitive impairment in patients of outpatient psychiatric offices across the geographical area of the Czech Republic. 1000 patients in 90 psychiatric offices will undergo cognitive tests (ALBA and PICNIR) and psychometric scales (sFAQ-CZ and GDS-CZ) to asses their functional state and depressive symptoms. If applicable, caretakers will also be asked about the extent of the participant's autonomy and behavioral impairment (using oFAQ-CZ and MBI-C-CZ scales).

The trial's primary goal is to assess the distribution of cognitive impairment among diagnostic groups in psychiatric care according to the ICD-10. Additionally, the feasibility of ALBA and PICNIR methods to uncover previously undiagnosed cognitive impairments will be evaluated.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Teaching Hospital Královské Vinohrady

Prague, 10000, Czechia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Dispensarization of at least six months in an outpatient psychiatric office with an ICD-10 diagnosis
  • Age>=45
  • Permanent residency in the geographical area of the Czech Republic

Exclusion criteria

  • Diagnosis of mental retardation (F70-F79) according to ICD-10
  • Refusal to sign the informed consent and consent with GDPR
  • Uncorrected visual impairment
  • Uncorrected auditory impairment
  • Inability to participate in the project

Treatment and study plan

Primary outcomes

  1. Baseline ALBA

    Time frame: Established on Day 0 as a single assessment.

    Amnesia Light and Brief Assessment (ALBA) test is an innovative method to assess cognitive functions quickly. The cognitive performance is scaled as an overall score between 0-12 (a lower value denotes a more severe cognitive impairment).

  2. Baseline PICNIR

    Time frame: Established on Day 0 as a single assessment.

    Picture Naming and Immediate Recall test (PICNIR) is an innovative test method to assess cognitive functions quickly. The cognitive performance is scaled as an overall score between 0-20 (a lower value denotes a more severe cognitive impairment).

  3. Statistical analysis of ALBA results,

    Time frame: The final statistical analysis will be performed through study completion, an average of 6 months.

    Statistical analysis of ALBA results compared to groups determined by ICD-10 diagnosis and demographical data.

  4. Statistical analysis of PICNIR results.

    Time frame: The final statistical analysis will be performed through study completion, an average of 6 months.

    Statistical analysis of PICNIR results compared to groups determined by ICD-10 diagnosis and demographical data.

Secondary outcomes

  1. Baseline MBI-C-CZ

    Time frame: Established as a baseline on Day 0.

    Mild Behavioral Impairment - Checklist - Czech version (MBI-C-CZ) is a standardized questionnaire to assess behavioral impairment in 34 items. Each item is scaled between 0-3 (a higher value denotes a higher severity) to reach the overall score between 0-102 (a higher value denotes a higher overall severity of behavioral impairments)

  2. Baseline sFAQ-CZ

    Time frame: Established as a baseline on Day 0.

    Functional Activities Questionnaire - Czech version (FAQ-CZ) is a standardized questionnaire administered to assess a patient´s functional state regarding daily activities. Ten items of daily functioning are scaled between 0-3 (a higher value denotes a higher dependency) to reach the overall score between 0-30 (a higher value denotes a higher dependency). This version of the scale will be used for participants´ self-evaluation.

  3. Baseline GDS-CZ

    Time frame: Established as a baseline on Day 0.

    The Geriatric Depression Scale - Czech version (GDS-CZ) is a standardized questionnaire administered to assess depressive symptoms, particularly in the elderly population. Fifteen items are scaled between 0-1 to reach the overall score between 0-15 (a higher value denotes a higher level of depressive symptoms).

  4. Baseline oFAQ-CZ

    Time frame: Established as a baseline on Day 0.

    Functional Activities Questionnaire - Czech version (FAQ-CZ) is a standardized questionnaire administered to assess a patient´s functional state regarding daily activities. Ten items of daily functioning are scaled between 0-3 (a higher value denotes a higher dependency) to reach the overall score between 0-30 (a higher value denotes a higher dependency). This version of the scale will be used for caretakers´ evaluation of participants´ functioning.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

PAPSY: Snadné zjištění Poruch paměti pomocí Velmi krátkých testů ALBA a POBAV u psychiatrických diagnóz v celé ČR

Acronym: PAPSY

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
May 6, 2023
Registry last updated
Jul 16, 2025

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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