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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06214039
Other study ID # VRanx_001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 14, 2024
Est. completion date May 2026

Study information

Verified date November 2023
Source Vilnius University
Contact Jonas Eimontas, PhD
Phone +37052667615
Email jonas.eimontas@fsf.vu.lt
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date May 2026
Est. primary completion date May 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Lithuania Vilnius University Vilnius

Sponsors (4)

Lead Sponsor Collaborator
Vilnius University Linkoeping University, Stockholm University, Thomas More University of Applied Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
See also
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