NCT05735860

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

December 14, 2022

Last Update Submit

February 9, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (18)

  • Subjective Units of Distress (SUDs) during the BAT

    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)

    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)

    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)

    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)

    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)

  • +13 more secondary outcomes

Study Arms (2)

Virtual Reality Exposure Therapy (VRET)

EXPERIMENTAL
Behavioral: Virtual Reality Exposure Therapy (VRET)

Progressive Muscle Relaxation (PMR)

ACTIVE COMPARATOR
Behavioral: Progressive Muscle Relaxation (PMR)

Interventions

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.

Virtual Reality Exposure Therapy (VRET)

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.

Progressive Muscle Relaxation (PMR)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Psychosomatics, and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg

Würzburg, 97080, Germany

RECRUITING

Related Publications (1)

  • Bellinger D, Wehrmann K, Rohde A, Schuppert M, Stork S, Flohr-Jost M, Gall D, Pauli P, Deckert J, Herrmann MJ, Erhardt-Lehmann A. The application of virtual reality exposure versus relaxation training in music performance anxiety: a randomized controlled study. BMC Psychiatry. 2023 Aug 1;23(1):555. doi: 10.1186/s12888-023-05040-z.

MeSH Terms

Interventions

Virtual Reality Exposure TherapyAutogenic Training

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesHypnosisMind-Body TherapiesComplementary TherapiesTherapeutics

Central Study Contacts

Daniel Bellinger, Dr. med.

CONTACT

Kristin Wehrmann, M. Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled / two-arm parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2022

First Posted

February 21, 2023

Study Start

January 11, 2022

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations