Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT01357694
Eligibility Criteria:
Inclusion and exclusion criteria for participating at the preoperative computer-assisted self assessment were defined as follows:
Inclusion criteria:
* Written informed consent to participate in the first part of study after having been properly instructed
* patient of the preoperative anesthesiological assessment clinic
* age ≥18 years.
Exclusion criteria:
* Surgery with an emergency or urgent indication
* inability to attend the preoperative assessment clinic (bedside visit)
* insufficient knowledge of German language
* members of the hospital staff
* admitted in police custody
* accommodation in an institution by official or court order
* being under guardianship
* psychiatric, neurological or other condition associated with limited legal capability or limited capability of being properly instructed or giving informed consent.
Additional inclusion and exclusion criteria of the RCT (Enrollment: 220 patients) were defined as follows:
Inclusion criteria:
* Written informed consent to participate in the RCT after having been properly instructed
* acute significant psychiatric distress (scoring above of at least one of the cut-off values of WHO-5, PHQ-2, GAD-2, HADS-D, HADS-A, AUDIT) and/or being tobacco smoker, and/or having consumed illicit drugs during the last 12 months.
Exclusion criteria:
* Acute severe psychiatric condition (acute episode of psychotic disorder, severe substance use disorder including serious withdrawal symptoms)
* severe acute suicidality
* homelessness
* participation in a psychopharmacological clinical trial at baseline assessment or 1 month before, respectively.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01357694
Study Brief:
Protocol Section:
NCT01357694