Study design
mental disorders, depressive, psychiatric, anxiety
DISORDER, PMR, ADVERSE EVENTS, DISEASE
The prospective, randomized trial has a pre-post design and includes a follow-up period of 6 months (see Fig. At a first screening appointment (S), inclusion and exclusion criteria will be checked. The study information will be provided and written informed consent will be obtained. The study was approved by the ethics committee of the University of Würzburg (No. 194/21-sc). The project is in line with the Helsinki Declaration (as of October 2013, Fortaleza, Brazil) and Good Clinical Practice (GCP). Eligible musicians will be stratified by sex (male vs. female) and then randomized in two therapy arms, i.e. VRET or PMR. The randomization is carried out at the end of the screening appointment (S) by the investigators (DB or KW), who assign the musicians in chronological order to a previously defined random order of treatment conditions that has been generated by a computer. The subjects know from beginning about the random assignment of treatment conditions and they agree with it by filling the informed consent. They are told about their assigned intervention by the investigator (DB or KW) at the end of the pre- treatment assessment (T0) (single-blind randomization). Thereafter, screening questions concerning onset, form, and severity of MPA based on the criteria for specific phobia according to ICD 10 (F40.2) and social anxiety disorder according to DSM V (300.23, F40.10) will be addressed. A clinical interview for diagnosing mental disorders (Mini-DIPS-OA, [For each treatment condition (VRET vs. PMR) four individual therapy sessions within two weeks will take place on site at the University Hospital in Würzburg. Subjective as well as behavioral data will be collected at T0, T1 and T2, to describe the severity of MPA (see 2.5). For the assessment of the behavioral and physiological data a behavioral assessment test (BAT) in VR is conducted, during which the participant performs a musical audition (see 2.5.1).In general, participants can discontinue or cancel the participation of the study at any time without giving reasons. In case of a high depressive or anxiety symptom burden in terms of worsening disease or even adverse events up to suicidal crisis, a psychiatric consultation will inform participants about alternative treatments, but this is not being realized as part of the study. Throughout the course of the therapeutic intervention modifying allocated interventions for a given trial participant are not provided (e.g. participant request, or improving/worsening disease).This study was registered on clinicaltrials.gov. (ClinicalTrials.gov Number: NCT05735860; Protocol version of 02/09/2023 with ID: 194/21-sc)
Timeline of screening and assessment at time points T0, T1, and T2 during the study