Virtual Reality Exposure for Public Speaking Anxiety (VRanx)

May 23, 2024 updated by: 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Public Speaking Anxiety Scale (PSAS), (Bartholomay & Houlihan, 2016).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Liebowitz Social Anxiety Scale - Self-Report (LSAS-SR), (Liebowitz, 2003; Rytwinski et al., 2009)
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), (Leary, 1983)
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.
Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
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
Patient health questionnaire - 9 (PHQ-9), (Spitzer et al., 1999)
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. 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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vilnius University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Linkoeping University
Stockholm University
Thomas More University of Applied Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Public Speaking Anxiety

Clinical Trials on Exposure in virtual reality and text based cognitive behavioral therapy (CBT) for public speaking anxiety

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings