Virtual Reality Exposure for Public Speaking Anxiety (VRanx)

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: Recruiting
• Conditions: Public Speaking Anxiety
• Intervention / Treatment: Behavioral: Exposure in virtual reality and text based cognitive behavioral therapy (CBT) for public speaking anxiety

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonas Eimontas, PhD; Phone Number: +37052667615; Email: jonas.eimontas@fsf.vu.lt

Study Locations

• Lithuania
  • Vilnius, Lithuania, LT-01513
    • Recruiting
    • Vilnius University
    • Contact: Jonas Eimontas, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• aged 18-30 and studying in 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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	Behavioral: Exposure in virtual reality and text based cognitive behavioral therapy (CBT) for public speaking anxiety; 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	Behavioral: Exposure in virtual reality and text based cognitive behavioral therapy (CBT) for public speaking anxiety; 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), (Bartholomay & Houlihan, 2016).	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
Liebowitz Social Anxiety Scale - Self-Report (LSAS-SR), (Liebowitz, 2003; Rytwinski et al., 2009)	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), (Leary, 1983)	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.	Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
Igroup Presence Questionnaire (IPQ)	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
Patient health questionnaire - 9 (PHQ-9), (Spitzer et al., 1999)	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, 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)	Each measure will be rated on a scale from 0 to 100. Higher number indicates higher distress.	Pre-intervention, immediately after the intervention

Collaborators and Investigators

• Sponsor: Vilnius University
• Collaborators: Linkoeping University; Stockholm University; Thomas More University of Applied Sciences
• Investigators: Study Chair: Jonas Eimontas, PhD, Vilnius University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 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): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: social anxiety; virtual reality; exposure; psychological intervention; public speaking anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• 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