NCT07351409

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

December 22, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 20, 2026

Status Verified

October 1, 2025

Enrollment Period

8 months

First QC Date

December 22, 2025

Last Update Submit

January 9, 2026

Conditions

Keywords

Public speaking anxietyuniversity counselingVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Public Speaking Anxiety at VR Post-Treatment

    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).

Secondary Outcomes (6)

  • Heart Rate During Intervention Sessions

    During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)

  • Heart Rate Variability During Intervention Sessions

    During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)

  • Electrodermal Activity During Intervention Sessions

    During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)

  • Skin Temperature During Intervention Sessions

    During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)

  • Movement and Activity Levels During Intervention Sessions

    During intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)

  • +1 more secondary outcomes

Other Outcomes (1)

  • Change From Baseline in Public Speaking Anxiety at 3-Month Follow-Up

    Baseline (T0) and 3-month follow-up (T2) (approximately 3 months after treatment completion).

Study Arms (2)

Experimental Arm: VR (360°) Modules (VR-ERP + VR-ACT) + Standard Counseling

EXPERIMENTAL

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.

Device: Exposure and Response Prevention (ERP)Device: Acceptance and Commitment Therapy (ACT) training

Control Arm: Standard Counseling (No VR)

ACTIVE COMPARATOR

Standard counseling sessions will be conducted by one psychotherapist for 6 consecutive weeks in 60-minute sessions.

Behavioral: Counseling program

Interventions

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.

Experimental Arm: VR (360°) Modules (VR-ERP + VR-ACT) + Standard Counseling

to simulate feared-anxiety-evoking scenarios, allowing both assessment and training for situationally induced anxiety to progressively promote desensitization to the anxiety-provoking stimuli

Experimental Arm: VR (360°) Modules (VR-ERP + VR-ACT) + Standard Counseling

Standard counseling sessions will be conducted by one psychotherapist for 6 consecutive weeks in 60-minute sessions.

Control Arm: Standard Counseling (No VR)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calabria

Rende, CS, 87036, Italy

Location

Related Publications (12)

  • 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.

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

FRANCESCO CRAIG, PhD

CONTACT

Fabio Bruno, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled, parallel-group interventional study with two independent arms (1:1 allocation): (1) an experimental group and (2) a control group. Both groups receive a brief standard counseling program consisting of six individual sessions delivered by trained clinicians within the University Psychological Counseling Service (UPCS). The experimental group receives the same counseling program plus two immersive VR modules delivered via 360° video scenarios: (a) VR-Exposure and Response Prevention (VR-ERP) for graded, controlled exposure to public-speaking situations, and (b) VR-Acceptance and Commitment Training (VR-ACT) providing ACT-consistent mindfulness and psychological flexibility exercises aimed at reducing arousal and enhancing coping. The control group receives counseling only (no VR). Outcomes are assessed at baseline (T0), post-treatment (T1), and follow-up (T2) to evaluate changes over time and between-group differences.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 20, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

October 12, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 20, 2026

Record last verified: 2025-10

Locations