Clinical trial NCT05735860: The Application of Virtual Reality Exposure Versus Relaxation Training in Music Performance Anxiety
Official title: Die Nutzung Virtueller Realität Zur Behandlung Von Auftrittsangst
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Music Performance Anxiety
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled / two-arm parallel assignment
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effect of exposure treatment using virtual reality (VR) in musicians with performance anxiety compared to a relaxation technique on anxiety symptoms and corresponding cardiovascular parameters. The prospective, randomized clinical trial will include 46 musicians with musical performance anxiety (MPA). The experimental group will receive four exposure sessions in VR and the control group will receive four progressive muscle relaxation (PMR) sessions. Anxiety symptoms will be measured using a german version of the Performance Anxiety Questionnaire and a behavioral assessment test (BAT) before, after the treatment, and at 6-month follow-up. The cardiovascular reactivity will be assessed measuring the heart rate variability (HRV) throughout the BAT and the blood pressure before and after the BAT. Furthermore, blood and saliva samples will be collected before and after the BAT to assess endocrine stress parameters and epigenetic markers. The following hypotheses are derived: 1) Significant and lasting reduction of subjective MPA symptoms for the experimental group receiving VRET at T1 (post/ shortly after treatment) and T2 (follow-up/ 6 months after treatment) compared to T0 (pre/ before treatment). 2) Significant better reduction of subjective MPA symptoms for the experimental group receiving VRET compared to the control group receiving PMR at T1 (post/shortly after treatment) and T2 (follow-up/ 6 months after treatment) compared to T0 (pre/ before treatment). 3) The postulated effects in hypotheses 1 and 2 go along with a significantly higher HRV representing less cardiac stress during the BAT in case of a successful reduction of anxiety symptoms at T1 (post/ shortly after treatment) and T2 (follow-up/ 6 months after treatment) compared to T0 (pre/ before treatment).


Eligibility criteria: Inclusion Criteria:

* Music performance anxiety (MPA)

  * Reporting anxiety and/or avoidance of musical performance situations
  * Reporting psychological distress and/or impaired functioning due to the MPA
* Sufficient knowledge of the German language (to understand questionnaires and the therapy manual)
* Compliance with the covid-19-regulations for local study appointments
* Written informed consent

Exclusion Criteria:

* Substance use disorder
* Physiological contraindications for an exposure therapy (i.e. epilepsy, serious disorder of the cardiovascular system)
* Psychological contraindications for an exposure therapy (i.e. psychotic disorder, substance dependence, borderline personality disorder, acute suicidality)
* Use of sedative medication or tranquilizers (i.e. beta-blockers) for the therapy appointments
* Claustrophobia
* Blood-injection-injury type phobia
* Instrument not portable, too big or not playable while standing (i.e. piano, drums, harp, double bass)
* Not able to play the instrument blindfold
* Current psychotherapy because of the MPA
* Recent (\< 6 months ago) psychotherapy because of the MPA

Primary outcomes:
measure: German Version of the Performance Anxiety Questionnaire (Fehm, 2002)
timeFrame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
measure: Heart rate variability
timeFrame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Secondary outcomes:
measure: Subjective Units of Distress (SUDs) during the BAT
timeFrame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
measure: Social Interaction Anxiety Scale (SIAS)
timeFrame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
measure: Social Phobia Scale (SPS)
timeFrame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
measure: Beck Depression Inventory (BDI-II)
timeFrame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
measure: Anxiety Sensitivity Index (ASI-3)
timeFrame: Only one assessment at T0 (pre/ before treatment)
measure: State Trait Anxiety Inventory - Trait (STAI-Trait)
timeFrame: Only one assessment at T0 (pre/ before treatment)
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: Only one assessment at T0 (pre/ before treatment)
measure: Immersive Tendencies Questionnaire (ITQ)
timeFrame: Only one assessment at T0 (pre/ before treatment)
measure: Uncertainty Tolerance Scale (UGTS)
timeFrame: Only one assessment at T0 (pre/ before treatment)
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Change from before to after (approx. 45min later) the BAT in VR at T0 (pre/ before treatment), T1 (post/ approx. one week after treatment) and T2 (follow-up/ 6 months after treatment)
measure: Blood pressure
timeFrame: Change from before to after (approx. 30min later) the BAT in VR at T0, T1 and T2; and changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
measure: Heart rate
timeFrame: Change from before to after (approx. 30min later) the BAT in VR at T0, T1 and T2; and changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
measure: Salivary cortisol hormone
timeFrame: Change from before to after (approx. 30min later) the BAT in VR at T0, T1 and T2; and changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
measure: Neuropeptides
timeFrame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
measure: Epigenetic Targets
timeFrame: Change from before to after (approx. 30min later) the BAT in VR at T0, T1 and T2; and changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
measure: Kenny Music Performance Anxiety Inventory-Revised (K-MPAI-R)
timeFrame: Change from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
measure: Questionnaire on safety- and avoidance behaviors for musicians (Mumm et al., 2020)
timeFrame: Change from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Department of Psychiatry, Psychosomatics, and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg
Study officials:
References: