PAPSY - Memory in Psychiatry

NCT05843357 | Active Not Recruiting

• 1 other identifier: PAPSY
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Impairment

Keywords

Cognitive Impairment; Outpatient Psychiatric Service; Population Distribution

Outcome Measures

Primary Outcomes (4)

• Baseline ALBA

  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).

  Established on Day 0 as a single assessment.

• Baseline PICNIR

  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).

  Established on Day 0 as a single assessment.

• Statistical analysis of ALBA results,

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

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

• Statistical analysis of PICNIR results.

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

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

Secondary Outcomes (4)

• Baseline MBI-C-CZ

  Established as a baseline on Day 0.

• Baseline sFAQ-CZ

  Established as a baseline on Day 0.

• Baseline GDS-CZ

  Established as a baseline on Day 0.

• Baseline oFAQ-CZ

  Established as a baseline on Day 0.

Study Arms (1)

Observed group

No intervention will be administered on behalf of the project. The participants will be tested using ALBA and PICNIR (non-invasive) cognitive tests, and further sFAQ-CZ and GDS-CZ questionnaires will be administered. Questionnaires FAQ-CZ and MBI-C-CZ will be distributed to participants´ caretakers.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population is intended to be comprised of persons (45yrs+) living in the geographical area of the Czech Republic undergoing a treatment at an outpatient psychiatric office for a diagnosis defined in ICD-10 (excluding mental retardation). The probability sample will be created by a random selection of persons undergoing their regular outpatient psychiatric checkups.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Teaching Hospital Královské Vinohrady

Prague, Prague, 10000, Czechia

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Aleš Bartoš, M.D., Ph.D.

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

• Tadeáš Mareš, M.D.

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultation-liaison psychiatrist

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: May 6, 2023
• Study Start: March 8, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon the final publication of the outcomes, indefinitely.
• Access Criteria: Being a verified researcher.

Locations

CZ (1)