Adverse event reporting and harms {22}
depressive, psychiatric, self-harm, anxiety
ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT
Adverse events such as suicidality, self-harm, or extreme increases in depressive or anxiety symptoms and other unintended effects of trial interventions or trial conduct will be assessed through standardized questions about suicidality and symptoms at the pre-intervention, post-intervention, and follow-up assessment, plus spontaneously reported feedback from participants (e.g., via the study e-mail). If there are indications for adverse events, the study team will—according to a risk management protocol—contact licensed clinical psychologists associated with the study, who will then call the respective participants to confirm the occurrence of an adverse event and act accordingly, i.e., direct the participant to psychiatric care. Adverse events will be reported on a regular base to the ethics committee of the faculty of psychology and learning sciences of LMU Munich.