Anxiety and DistressVR-CounselingNCT07351409
VR-Counseling to Reduce Public Speaking Anxiety
A study testing Exposure and Response Prevention (ERP), Acceptance and Commitment Therapy (ACT) training and Counseling program in people with Anxiety and Distress and Anxiety, run by University of Calabria at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anxiety and Distress, Anxiety, Anxiety Disease
- What is being tested?
- Exposure and Response Prevention (ERP), Acceptance and Commitment Therapy (ACT) training and Counseling program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
University of Calabria
Rende, CS, 87036
Francesco Craig, PHD, +39 3274432477, francesco.craig@unical.it
About this study
Official title: 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.
- Being tested
- Exposure and Response Prevention (ERP), Acceptance and Commitment Therapy (ACT) training, Counseling program
- Keywords
- Public speaking anxiety, university counseling, Virtual Reality
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure and Response Prevention (ERP)Device
to simulate feared-anxiety-evoking scenarios, allowing both assessment and training for situationally induced anxiety to progressively promote desensitization to the anxiety-provoking stimuli
Acceptance and Commitment Therapy (ACT) trainingDevice
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.
Counseling programBehavioural
Standard counseling sessions will be conducted by one psychotherapist for 6 consecutive weeks in 60-minute sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Counseling program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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
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.
Measured: During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
Electrodermal Activity During Intervention Sessions
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.
Measured: During VR intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
Skin Temperature During Intervention Sessions
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.
Measured: 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
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.
Measured: During intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
Change From Baseline in Anxiety at VR Post-Treatment
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.
Measured: During intervention sessions, from session 1 (T0) through session 4 (T1 - end of the 4-week intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion12 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Anxiety and DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calabria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Craig, University of Calabria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351409
- Sponsor's protocol ID
- RV-PSI_13/03/2023_n. 318
- Acronym
- VR-Counseling
- Status last verified
- Oct 2025
- First submitted
- 22 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data (IPD) underlying the results reported in publications will be made available upon reasonable request. Data will be shared in a de-identified format in accordance with applicable privacy regulations (e.g., GDPR).
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.
PubMed 33533265Kampmann 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.
PubMed 27376634Kampmann 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.
PubMed 26752328Kahlon 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.
PubMed 31890004Huang 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.
PubMed 30300732Hendriks 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.
PubMed 38973756Donnelly 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.
PubMed 34817595Craig 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.
PubMed 40861352Copeland 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.
PubMed 33091568Cerolini 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.
PubMed 37754472Gallego 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.
PubMed 33593107Auerbach 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.
PubMed 30211576Colella GM, Silvestro E, Cosentino V, Capparelli V, Gravina A, Barbieri L, Costabile A, Bruno F, Craig F. Immersive virtual reality for reducing public speaking anxiety in students accessing a university psychological counseling service: protocol for a randomized controlled trial. BMC Psychol. 2026 Mar 23;14(1):638. doi: 10.1186/s40359-026-04418-4.
PubMed 41866578
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality as a Tool for Reducing Public Speaking Anxiety in Students Accessing the University Psychological Counseling Service: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07351409
- Acronym / sponsor ID
- VR-Counseling / RV-PSI_13/03/2023_n. 318
- Keywords
- Public speaking anxiety, university counseling, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of CalabriaUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: VR (360°) Modules (VR-ERP + VR-ACT) + Standard Counseling | Experimental | Device: Exposure and Response Prevention (ERP), Device: Acceptance and Commitment Therapy (ACT) trainingThe 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. |
| Control Arm: Standard Counseling (No VR) | Active comparator | Behavioral: Counseling programStandard counseling sessions will be conducted by one psychotherapist for 6 consecutive weeks in 60-minute sessions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure and Response Prevention (ERP)to simulate feared-anxiety-evoking scenarios, allowing both assessment and training for situationally induced anxiety to progressively promote desensitization to the anxiety-provoking stimuli | Device | Experimental Arm: VR (360°) Modules (VR-ERP + VR-ACT) + Standard Counseling |
| Acceptance and Commitment Therapy (ACT) trainingto 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. | Device | Experimental Arm: VR (360°) Modules (VR-ERP + VR-ACT) + Standard Counseling |
| Counseling programStandard counseling sessions will be conducted by one psychotherapist for 6 consecutive weeks in 60-minute sessions. | Behavioural | Control Arm: Standard Counseling (No VR) |
Primary outcome
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).
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
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Results publication: PubMed 33533265Reeves 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.
- Results publication: PubMed 27376634Kampmann 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.
- Results publication: PubMed 26752328Kampmann 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.
- Results publication: PubMed 31890004Kahlon 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.
- Results publication: PubMed 30300732Huang 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.
- Results publication: PubMed 38973756Hendriks 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.
- Results publication: PubMed 34817595Donnelly 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.
- Results publication: PubMed 40861352Craig 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.
- Results publication: PubMed 33091568Copeland 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.
- Results publication: PubMed 37754472Cerolini 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.
- Results publication: PubMed 33593107Gallego 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.
- Results publication: PubMed 30211576Auerbach 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.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data (IPD) underlying the results reported in publications will be made available upon reasonable request. Data will be shared in a de-identified format in accordance with applicable privacy regulations (e.g., GDPR).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure and Response Prevention (ERP), Acceptance and Commitment Therapy (ACT) training and Counseling program in people with Anxiety and Distress and Anxiety, run by University of Calabria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FRANCESCO CRAIG, PhD (+39 3274432477, francesco.craig@unical.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07351409, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.