Validation of the german version of ESC Screener 2.0 in patients with coronary heart disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023740

Enrollment

313

Registered

2020-12-02

Start date

2021-01-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25.1

Interventions

Group 1: patients who underwent a heart catheterization independent of the indication will be asked to fill out the following questionnaires: PHQ-9, GAD-7, SMSS, ERI-16, PC-PTSD, DS14, Z-scale of MMPI

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - patients who underwent a heart catheterization independent of the indication - german speaking

Exclusion criteria

Exclusion criteria: - palliative setting of other reason - non german speaking

Design outcomes

Primary

Measure	Time frame
-a confirmatory factor analysis will be run incorporating all constructs, examining a bi-factor model (screener – full scale). The hierarchical omega value will then indicate the percentage of variance in both scales explained by the same underlying latent factor [1]. -for test-retest- reliability intra-class-correlations will be calculated for the continuous scores on the screener subscales with the matching full-scale instrument. This will enable conclusions about rank order validity -for the depression and anxiety thresholds as well as type D personality ROC curves will be generated to determine the optimal levels of sensitivity and specificity and with those define cut-off values using the Youden´s J statistic. Additionally, predictive values will be calculated	—

Measure

Time frame

-a confirmatory factor analysis will be run incorporating all constructs, examining a bi-factor model (screener – full scale). The hierarchical omega value will then indicate the percentage of variance in both scales explained by the same underlying latent factor [1]. -for test-retest- reliability intra-class-correlations will be calculated for the continuous scores on the screener subscales with the matching full-scale instrument. This will enable conclusions about rank order validity -for the depression and anxiety thresholds as well as type D personality ROC curves will be generated to determine the optimal levels of sensitivity and specificity and with those define cut-off values using the Youden´s J statistic. Additionally, predictive values will be calculated

—

Secondary

Measure	Time frame
- to estimate the agreement between the screener and the gold standard scales -depending on the structure of missing values-Cohen´s kappa or Krippendorff´s alpha values will be calculated for the constructs with given thresholds. - comparison of patients at risk for CHD vs manifest CHD – exploratory analysis of the above mentioned (ROC-curves, agreement measures) - exploratory sensitivity analyses of different weighting approaches in comparison to Youden´s J statistic	—

Measure

Time frame

- to estimate the agreement between the screener and the gold standard scales -depending on the structure of missing values-Cohen´s kappa or Krippendorff´s alpha values will be calculated for the constructs with given thresholds. - comparison of patients at risk for CHD vs manifest CHD – exploratory analysis of the above mentioned (ROC-curves, agreement measures) - exploratory sensitivity analyses of different weighting approaches in comparison to Youden´s J statistic

—

Countries

Germany

Contacts

Public ContactJulian Colberg

Bundeswehrzentralkrankenhaus Koblenz

julian.colberg@smail.uni-koeln.de026128121006

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026