- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06214039
Virtual Reality Exposure for Public Speaking Anxiety (VRanx)
July 16, 2026 updated by: Jonas Eimontas, Vilnius University
Virtual Reality Based Cognitive Behavioral Therapy for Public Speaking Anxiety
This study aims to examine the efficacy of exposure using virtual reality (VR) for public speaking anxiety in young adults in two treatment arms: a one-session VR exposure therapy with a 4-week online transition intervention versus a three-session VR exposure therapy with a 4-week online transition intervention.
Previous studies have demonstrated that one-session therapy (OST) is comparable to prolonged exposure-based therapies in terms of effectively reducing public speaking anxiety.
Moreover, VR offers many benefits compared to in-person exposure, namely the ability to produce anxiety-evoking stimuli without having to leave the therapist's room.
However, OST VR exposure has not been directly compared to prolonged VR exposure and not for public speaking anxiety.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lithuania
-
Vilnius, Lithuania, Lithuania, LT-01513
- Vilnius University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- aged 18-30 and pursuing higher education;
- experiencing a significant level of public speaking anxiety (60+ on PSAS);
- able to use a computer and have access to the internet for the duration of the study;
- able to understand, write and speak in Lithuanian;
- available to participate in one or three in-person intervention sessions and can devote the time to participate in a 4-week online program following the intervention sessions.
Exclusion Criteria:
- a history of seizures or a history of epilepsy;
- other significant medical conditions that would prevent them from participating in the program;
- high levels of depression (Patient Health Questionnaire-9 rating of 15 and above and mentions of suicidal ideation) or other significant psychiatric conditions that would interfere with participation in the program;
- a tendency to have extreme seasickness reactions or a history of adverse physical reactions to virtual reality experiences or difficulty with or lack of stereoscopic vision;
- current involvement in other psychological interventions such as psychological counseling or psychotherapy;
- use of psychoactive drugs, unless stable for three months;
- current participation in other programs aimed at reducing public speaking anxiety.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: One session therapy
One session exposure therapy followed by 4 weeks of internet-delivered self-help with therapist support on demand
|
A 3-hour one session exposure therapy for public speaking anxiety
|
|
Experimental: One session therapy - divided into 3
Three session exposure therapy followed by 4 weeks of internet-delivered self-help with therapist support on demand
|
A 3-hour one session exposure therapy for public speaking anxiety
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Public Speaking Anxiety Scale (PSAS).
Time Frame: Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
|
Canonical total score will be used.
Measure is self-rated, online.
The scale consists of 17 self-report statements measured on a Likert-type scale ranging from 1 "not at all", to 5 "extremely".
A higher score indicates higher levels of experienced public speaking anxiety.
|
Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Igroup Presence Questionnaire (IPQ)
Time Frame: Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
|
Canonical total score will be used.
Measure is self-rated, online.
Each of the 14 items is rated on a 7-point Likert scale and the score is calculated by summing the ratings for each item.
|
Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
|
|
Liebowitz Social Anxiety Scale - Self-Report (LSAS-SR)
Time Frame: Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
|
Canonical total score will be used.
Measure is self-rated, online.
Items are rated using 4-point Likert scales ranging from 0 to 3. A higher score indicates more severe symptoms.
|
Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
|
|
Brief Fear of Negative Evaluation Scale (BFNE)
Time Frame: Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
|
Canonical total score will be used.
Measure is self-rated, online.
The BFNE is a 12-item, 5-point Likert-type scale, ranging from 1 "not at all" to 5 "extremely".
Higher scores indicate higher fear.
In Lithuanian version of the BFNE the scores range from 0 "not at all" to 4 "extremely".
|
Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Units of Distress (SUD)
Time Frame: Pre-intervention, immediately after the intervention
|
Each measure will be rated on a scale from 0 to 100.
Higher number indicates higher distress.
|
Pre-intervention, immediately after the intervention
|
|
Patient health questionnaire - 9 (PHQ-9)
Time Frame: Pre-treatment
|
Canonical total score will be used.
Measure is self-rated, online.
PHQ-9 consists of 9 items that are rated depending on how often the symptoms were bothersome using a 4-point scale, ranging from 0 "not at all" to 3 "nearly every day".
The ratings are summed for the total score and higher scores indicates more severe depression symtpoms.
|
Pre-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jonas Eimontas, PhD, Vilnius University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2024
Primary Completion (Actual)
February 14, 2026
Study Completion (Actual)
April 1, 2026
Study Registration Dates
First Submitted
December 18, 2023
First Submitted That Met QC Criteria
January 9, 2024
First Posted (Actual)
January 19, 2024
Study Record Updates
Last Update Posted (Actual)
July 17, 2026
Last Update Submitted That Met QC Criteria
July 16, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VRanx_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Following the publication of trial results, participant-level data without identifying information, i.e., anonymized, will be stored on a national data archive MIDAS and will be made available to researchers affiliated with research institutions upon a reasonable request.
Statistical analysis procedures will be clearly defined in papers on trial results.
IPD Sharing Time Frame
Following the publication of the trial results.
IPD Sharing Access Criteria
Available to researchers affiliated with research institutions upon a reasonable request.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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