R57.0
Conditions
Interventions
Group 1: Prospective observational study: All patients who receive intensive care treatment for more than 48 hours due to cardiogenic shock will be assessed regadring their mental health at study enro
Sponsors
Universitäres Herz- und Gefäßzentrum Frankfurt
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients may participate in this study if they: • required intensive care treatment due to cardiogenic shock. • were treated in the intensive care unit for at least 48 hours. • are of legal age. • are mentally and physically capable of understanding the significance and implications of the study and following the instructions of the study staff. • have the legal capacity to consent and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: Patients cannot participate in the study if they: • are minors • suffer from a pre-existing cognitive impairment resulting in a lack of legal capacity • have a pre-existing neurological condition causing severe impairment in daily life • are receiving pharmacological treatment for a pre-existing mental illness • are suspected of having hypoxic brain damage • have a history of alcohol or drug abuse • are expected to be unwilling to actively participate in study-related procedures • are institutionalized by order of an authority or court • have a relationship of dependency or employment with the investigator or their deputy • are non-German speakers with insufficient English proficiency for whose native language no qualified translator is available, such that it must be assumed the content of the questionnaires cannot be adequately understood
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of clinically relevant symptoms of mental health disorders among survivors of cardiogenic shock at 1, 6, and 12 months after completion of intensive care treatment, assessed using validated, standardized psychometric questionnaires (Simplified Beck Depression Inventory [BDI-V], International Trauma Questionnaire – German version [ITQ], Heart Anxiety Questionnaire – German version [HAF]). A predefined cut-off value will be applied to dichotomize outcomes (symptomatology present vs. absent). The primary endpoint is considered achieved if at least one of the following conditions is met: * Presence of symptoms of a depressive disorder (BDI-V total score = 11 points) * Clinically relevant PTSD symptomatology (diagnostic criteria for PTSD according to the ITQ scoring algorithm, including symptom clusters and functional impairment, are fulfilled) * Anxiety disorder (HAF-17 total score = 2.14) Analyses will be performed both cross-sectionally at each assessment time point (1, 6, and 12 months) and longitudinally to evaluate the prevalence and course of psychological symptomatology over time. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Initiation of psychiatric medication: New initiation of psychopharmacological treatment (e.g., antidepressants, anxiolytics, antipsychotics) after discharge from the intensive care unit, recorded as a dichotomous variable (yes/no) at each follow-up assessment. * Utilization of psychotherapy: Receipt of outpatient or inpatient psychotherapeutic treatment within 12 months after ICU discharge, assessed by self-report during follow-up visits (yes/no). * Social isolation: Assessed using a validated questionnaire (Questionnaire on Social Support, F-SozU K-22). For dichotomization, social isolation is considered present if the total F-SozU K-22 score is = 3. * Impaired quality of life: Reduced health-related quality of life, measured using a validated questionnaire (EuroQol 5-Dimensions 5-Levels; EQ-5D-5L), reported as overall and subscale scores at 1, 6, and 12 months following intensive care treatment. | — |
Countries
Germany
Contacts
Public ContactRobert Stöhr
Universitäres Herz- und Gefäßzentrum Frankfurt
Outcome results
None listed