- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07351409
VR-Counseling to Reduce Public Speaking Anxiety (VR-Counseling)
Immersive Virtual Reality as a Tool for Reducing Public Speaking Anxiety in Students Accessing the University Psychological Counseling Service: A Randomized Controlled Trial
Public Speaking Anxiety (PSA) is a common manifestation of social anxiety among university students that can negatively impact academic performance and psychological well-being. Virtual Reality (VR) based interventions combined with Cognitive Behavioral Therapy (CBT) represent a promising approach to address PSA by enabling controlled, gradual exposure to feared social situations through realistic simulations of audiences and settings. This randomized controlled trial will evaluate whether integrating VR sessions into standard psychological counseling provided by the University Psychological Counseling Service (UPCS) improves anxiety and PSA outcomes in university students compared with counseling alone.
Participants will be randomized to one of two groups: (1) a control group receiving standard psychological counseling intervention, or (2) an experimental group receiving psychological counseling supplemented with VR interventions delivered via immersive 360° video scenarios. The VR-based intervention includes a VR-Exposure and Response Prevention (ERP) module offering graded exposure to anxiety-provoking public speaking contexts, and a VR-Acceptance and Commitment Training (ACT) module aimed at enhancing mindfulness and psychological flexibility through guided experiential exercises. Psychological outcomes and physiological responses recorded during sessions will be analyzed to compare the effectiveness of VR-integrated counseling versus standard counseling alone. This study addresses the limited evidence on CBT combined with 360° video-based VR exposure for PSA in university students and introduces a novel VR-based ERP and ACT protocol tailored to a university counseling setting.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Francesco Craig, PHD
- Phone Number: +39 3274432477
- Email: francesco.craig@unical.it
Study Contact Backup
- Name: Fabio Bruno, PhD
- Phone Number: 0984/494623
- Email: fabio.bruno@unical.it
Study Locations
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CS
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Rende, CS, Italy, 87036
- University of Calabria
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Contact:
- Francesco Craig, PHD
- Phone Number: +39 3274432477
- Email: francesco.craig@unical.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion criteria are:
- current enrollment at the university;
- request for psychological counseling at the UPCS;
- fluency in Italian;
- provision of written informed consent;
- the presence of at least moderate levels of anxiety and perceived stress, as indicated by scores on standardized assessment instruments. Specifically, scores between STAI scores from 35 to 50 and PRPSA scores from 85 to 110.
Exclusion criteria are:
- current psychotic disorder;
- acute suicidality;
- severe substance dependence;
- severe sensory or motor impairments that would prevent safe use of VR equipment;
- inability to attend the planned sessions;
- concurrent participation in other specialized psychotherapy programs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Arm: VR (360°) Modules (VR-ERP + VR-ACT) + Standard Counseling
The experimental intervention includes two distinct VR-based training scenarios: (A) VR-ERP, designed to gradually expose students to anxiety-provoking situations to prevent avoidance responses, and (B) VR-ACT training, a consistent mindfulness training aimed at enhancing psychological flexibility and value-oriented behaviors.
Participants in the experimental group, after VR-ACT training, go to standard counseling intervention.
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to simulate feared-anxiety-evoking scenarios, allowing both assessment and training for situationally induced anxiety to progressively promote desensitization to the anxiety-provoking stimuli
to provide an ACT-consistent mindfulness training targeting psychological flexibility processes, such as contact with the present moment, cognitive defusion, and acceptance, aimed at eliciting a grounding response within a digitally generated, safe environment.
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Active Comparator: Control Arm: Standard Counseling (No VR)
Standard counseling sessions will be conducted by one psychotherapist for 6 consecutive weeks in 60-minute sessions.
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Standard counseling sessions will be conducted by one psychotherapist for 6 consecutive weeks in 60-minute sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Public Speaking Anxiety at VR Post-Treatment
Time Frame: Baseline (T0) and end of VR intervention sessions (T1, at the end of the 4-week intervention period).
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Change from baseline to post-treatment in public speaking anxiety as assessed by the Personal Report of Public Speaking Anxiety (PRPSA), comparing the experimental arm with the control arm. The PRPSA is a self-report questionnaire designed to measure anxiety specifically related to speaking in front of an audience. It assesses cognitive, physiological, and behavioral components of public speaking anxiety, capturing both anticipatory anxiety and anxiety experienced during performance. The scale consists of 34 items rated on a 5-point Likert scale, with response options ranging from 1 = strongly disagree to 5 = strongly agree. Items reflect feelings of tension and nervousness, physiological arousal, negative self-appraisal, and fear of audience evaluation. Total scores range from 34 to 170, with higher scores indicating greater levels of public speaking anx |
Baseline (T0) and end of VR intervention sessions (T1, at the end of the 4-week intervention period).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate During Intervention Sessions
Time Frame: During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
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Heart rate is continuously recorded during each intervention session to assess physiological arousal and recovery and to examine whether VR-supported counseling is associated with different within-session heart rate responses compared with counseling alone.
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During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
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Heart Rate Variability During Intervention Sessions
Time Frame: During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
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Heart rate variability is continuously recorded during each intervention session as an index of autonomic regulation and physiological recovery, and to compare within-session variability between VR-supported counseling and counseling alone.
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During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
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Electrodermal Activity During Intervention Sessions
Time Frame: During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
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Electrodermal activity is continuously recorded during each intervention session to assess sympathetic nervous system activation and physiological arousal during counseling, and to compare responses between treatment arms.
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During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
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Skin Temperature During Intervention Sessions
Time Frame: During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
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Skin temperature is continuously recorded during each intervention session as an indicator of peripheral physiological responses associated with stress and recovery, and to evaluate differences between VR-supported counseling and counseling alone.
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During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
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Movement and Activity Levels During Intervention Sessions
Time Frame: During intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
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Movement and activity levels are continuously recorded during each intervention session to quantify physical activity and motion-related physiological responses and to compare within-session patterns between treatment arms.
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During intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
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Change From Baseline in Anxiety at VR Post-Treatment
Time Frame: During intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
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Change from baseline in anxiety assessed with the State-Trait Anxiety Inventory (STAI), Form Y, a widely used self-report questionnaire designed to measure two distinct dimensions of anxiety: (i) State Anxiety, a temporary emotional condition characterized by feelings of tension, apprehension, and heightened autonomic nervous system activity, reflecting how the respondent feels "right now, at this moment"; and (ii) Trait Anxiety, a relatively stable disposition to perceive situations as threatening and to respond with anxiety across time and contexts. Each subscale consists of 20 items rated on a 4-point Likert scale. Response options range from 1 = not at all to 4 = very much so for the State Anxiety subscale, and from 1 = almost never to 4 = almost always for the Trait Anxiety subscale. Total scores for each subscale range from 20 to 80, with higher scores indicating greater levels of anxiety. |
During intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Public Speaking Anxiety at 3-Month Follow-Up
Time Frame: Baseline (T0) and 3-month follow-up (T2) (approximately 3 months after treatment completion).
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Change from baseline (T0) to the 3-month follow-up (T2) in public speaking anxiety (PSA).
The experimental arm (VR intervention sessions) is expected to show greater sustained improvements at T2 compared with the control arm (brief standard counseling only).
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Baseline (T0) and 3-month follow-up (T2) (approximately 3 months after treatment completion).
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Reeves R, Curran D, Gleeson A, Hanna D. A Meta-Analysis of the Efficacy of Virtual Reality and In Vivo Exposure Therapy as Psychological Interventions for Public Speaking Anxiety. Behav Modif. 2022 Jul;46(4):937-965. doi: 10.1177/0145445521991102. Epub 2021 Feb 3.
- Kampmann IL, Emmelkamp PM, Morina N. Meta-analysis of technology-assisted interventions for social anxiety disorder. J Anxiety Disord. 2016 Aug;42:71-84. doi: 10.1016/j.janxdis.2016.06.007. Epub 2016 Jun 18.
- Kampmann IL, Emmelkamp PM, Hartanto D, Brinkman WP, Zijlstra BJ, Morina N. Exposure to virtual social interactions in the treatment of social anxiety disorder: A randomized controlled trial. Behav Res Ther. 2016 Feb;77:147-56. doi: 10.1016/j.brat.2015.12.016. Epub 2015 Dec 29.
- Kahlon S, Lindner P, Nordgreen T. Virtual reality exposure therapy for adolescents with fear of public speaking: a non-randomized feasibility and pilot study. Child Adolesc Psychiatry Ment Health. 2019 Dec 27;13:47. doi: 10.1186/s13034-019-0307-y. eCollection 2019.
- Huang J, Nigatu YT, Smail-Crevier R, Zhang X, Wang J. Interventions for common mental health problems among university and college students: A systematic review and meta-analysis of randomized controlled trials. J Psychiatr Res. 2018 Dec;107:1-10. doi: 10.1016/j.jpsychires.2018.09.018. Epub 2018 Sep 29.
- Hendriks GJ, Janssen N, Robertson L, van Balkom AJ, van Zelst WH, Wolfe S, Oude Voshaar RC, Uphoff E. Cognitive behavioural therapy and third-wave approaches for anxiety and related disorders in older people. Cochrane Database Syst Rev. 2024 Jul 8;7(7):CD007674. doi: 10.1002/14651858.CD007674.pub3.
- Donnelly MR, Reinberg R, Ito KL, Saldana D, Neureither M, Schmiesing A, Jahng E, Liew SL. Virtual Reality for the Treatment of Anxiety Disorders: A Scoping Review. Am J Occup Ther. 2021 Nov 1;75(6):7506205040. doi: 10.5014/ajot.2021.046169.
- Craig F, Colella GM, Tenuta F, Mauti M, Gravina A, Calomino ML, Plastina R, Polito A, Costabile A. From psychological wellbeing to distress: the role of psychological counseling interventions in university students. Front Psychol. 2025 Aug 8;16:1602009. doi: 10.3389/fpsyg.2025.1602009. eCollection 2025.
- Copeland WE, McGinnis E, Bai Y, Adams Z, Nardone H, Devadanam V, Rettew J, Hudziak JJ. Impact of COVID-19 Pandemic on College Student Mental Health and Wellness. J Am Acad Child Adolesc Psychiatry. 2021 Jan;60(1):134-141.e2. doi: 10.1016/j.jaac.2020.08.466. Epub 2020 Oct 19.
- Cerolini S, Zagaria A, Franchini C, Maniaci VG, Fortunato A, Petrocchi C, Speranza AM, Lombardo C. Psychological Counseling among University Students Worldwide: A Systematic Review. Eur J Investig Health Psychol Educ. 2023 Sep 14;13(9):1831-1849. doi: 10.3390/ejihpe13090133.
- Gallego A, McHugh L, Penttonen M, Lappalainen R. Measuring Public Speaking Anxiety: Self-report, behavioral, and physiological. Behav Modif. 2022 Jul;46(4):782-798. doi: 10.1177/0145445521994308. Epub 2021 Feb 16.
- Auerbach RP, Mortier P, Bruffaerts R, Alonso J, Benjet C, Cuijpers P, Demyttenaere K, Ebert DD, Green JG, Hasking P, Murray E, Nock MK, Pinder-Amaker S, Sampson NA, Stein DJ, Vilagut G, Zaslavsky AM, Kessler RC; WHO WMH-ICS Collaborators. WHO World Mental Health Surveys International College Student Project: Prevalence and distribution of mental disorders. J Abnorm Psychol. 2018 Oct;127(7):623-638. doi: 10.1037/abn0000362. Epub 2018 Sep 13.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RV-PSI_13/03/2023_n. 318
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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