The Application of Virtual Reality Exposure Versus Relaxation Training in Music Performance Anxiety

Die Nutzung Virtueller Realität Zur Behandlung Von Auftrittsangst

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).

Study Overview

• Status: Recruiting
• Conditions: Music Performance Anxiety
• Intervention / Treatment: Behavioral: Virtual Reality Exposure Therapy (VRET); Behavioral: Progressive Muscle Relaxation (PMR)

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Bellinger, Dr. med.; Phone Number: 0931/201-76345; Email: Bellinger_D@ukw.de
• Study Contact Backup: Name: Kristin Wehrmann, M. Sc.; Email: wehrmann_K2@ukw.de

Study Locations

• Germany
  • Würzburg, Germany, 97080
    • Recruiting
    • Department of Psychiatry, Psychosomatics, and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg
    • Contact: Jürgen Deckert, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Exposure Therapy (VRET)	Behavioral: Virtual Reality Exposure Therapy (VRET); Four VRET sessions of approx. one hour each session taking place in an individual setting accompanied by a therapist. The participants wear a head-mounted display showing different musical performance scenarios (i.e. audition in a concert hall/ recording studio/ in front of a professional jury/ an audience/ a class of music students) that are selected individually by a previously standardized, graded exposure procedure.
Active Comparator: Progressive Muscle Relaxation (PMR)	Behavioral: Progressive Muscle Relaxation (PMR); Four PMR sessions of approx. 45min each session taking place in an individual setting accompanied by a therapist. The sessions follow a previously standardized procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
German Version of the Performance Anxiety Questionnaire (Fehm, 2002)	Measuring subjective MPA symptoms for solo and ensemble performances by assessing the total score for the scale solo performance (0-80) and the total score for the scale ensemble performance (0-80). Higher scores indicate more symptoms of music performance anxiety.	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)
Heart rate variability	Measuring the cardiac reactivity throughout the BAT in virtual reality	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Units of Distress (SUDs) during the BAT	Measuring subjective MPA (0-100) in the BAT in virtual reality. Higher scores indicate a higher level of anxiety.	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)
Social Interaction Anxiety Scale (SIAS)	Measuring symptoms of social anxiety or distress specifically when talking or meeting others. A higher total score (0-80) indicates more symptoms of social anxiety.	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)
Social Phobia Scale (SPS)	Measuring symptoms of social phobia specifically in anticipation of or when actually being observed by others and when engaging in activities in the presence of others. A higher total score (0-80) indicates more symptoms of social anxiety.	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)
Beck Depression Inventory (BDI-II)	Measuring symptoms of depression. A higher total score (0-63) indicates more symptoms of depression.	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)
Beck Anxiety Inventory (BAI)	Measuring symptoms of anxiety. A higher total score (0-63) indicates more symptoms of anxiety.	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)
Anxiety Sensitivity Index (ASI-3)	Measuring anxiety sensitivity. A higher total score (0-56) indicates a higher level of anxiety sensitivity.	Only one assessment at T0 (pre/ before treatment)
State Trait Anxiety Inventory - Trait (STAI-Trait)	Measuring trait anxiety. A higher total score (20-80) indicates a higher level of trait anxiety.	Only one assessment at T0 (pre/ before treatment)
Childhood Trauma Questionnaire (CTQ)	Measuring childhood-history of abuse and neglect by assessing the total scores for the scales Emotional Neglect (7-35), Sexual Abuse (5-25), Physical Abuse and Neglect (7-35), and Emotional Abuse (5-25). Higher Scores indicate a higher level of childhood abuse and/or neglect.	Only one assessment at T0 (pre/ before treatment)
Immersive Tendencies Questionnaire (ITQ)	Measuring immersive tendencies. Higher scores on the scales Focus (5-35), Implication (5-25), Emotion (4-28), Joy (3-31) and a higher total score (17-119) indicate a higher level of immersive tendencies.	Only one assessment at T0 (pre/ before treatment)
Uncertainty Tolerance Scale (UGTS)	Measuring uncertainty tolerance. A higher total score (8-48) indicates a higher level of uncertainty tolerance.	Only one assessment at T0 (pre/ before treatment)
Positive and Negative Affect Schedule (PANAS)	Measuring state affect. Higher scores on the scales Positive Affect (10-50) and Negative Affect (10-50) indicate a higher level of positive or negative state affect.	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)
Blood pressure	Measuring cardiac stress	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)
Heart rate	Measuring cardiac stress	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)
Salivary cortisol hormone	Measuring the psychophysiological stress response	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)
Neuropeptides	Analysis of neuropeptides with modulating effects on humoral and behavioral stress response, and myocardial as well as autonomic nerve system function, such as Atrial natriuretic Polypeptide (ANP), neuropeptide Y (NPY), Oxytocin (OCT), salivary Alpha-Amylase (sAA).	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)
Epigenetic Targets	mDNA analysis of the candidate genes related to the endocrine stress reactivity (NR3C1, FKBP5, CRHR1) and DNAm analysis of Norepinephrine Transporter (NET) and Oxytocin Receptor (OXTR) genes due to their implication in the regulation of autonomous function and social anxiety	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)
Kenny Music Performance Anxiety Inventory-Revised (K-MPAI-R)	Measuring performance anxiety in musicians. A higher total score (0-240) indicates a higher level of music performance anxiety.	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)
Questionnaire on safety- and avoidance behaviors for musicians (Mumm et al., 2020)	Measuring the use of safety and avoidance behaviors in musicians. A higher total score (0-215) indicates a higher use of safety- and avoidance behaviors to reduce anxiety in performance situations.	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)

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Estimate): February 20, 2023

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 194/21-sc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No