Clinical trial NCT06214039: Virtual Reality Exposure for Public Speaking Anxiety
Official title: Virtual Reality Based Cognitive Behavioral Therapy for Public Speaking Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Public Speaking Anxiety
Keywords: public speaking anxiety
virtual reality
social anxiety
psychological intervention
exposure
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Linkoeping University
name: Stockholm University
name: Thomas More University of Applied Sciences
First posted: 2024-01-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Public Speaking Anxiety Scale (PSAS), (Bartholomay & Houlihan, 2016).
timeFrame: Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
Secondary outcomes:
measure: Liebowitz Social Anxiety Scale - Self-Report (LSAS-SR), (Liebowitz, 2003; Rytwinski et al., 2009)
timeFrame: Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
measure: Brief Fear of Negative Evaluation Scale (BFNE), (Leary, 1983)
timeFrame: Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
measure: Igroup Presence Questionnaire (IPQ)
timeFrame: Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
measure: Patient health questionnaire - 9 (PHQ-9), (Spitzer et al., 1999)
timeFrame: Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment
Other outcomes:
measure: Subjective Units of Distress (SUD)
timeFrame: Pre-intervention, immediately after the intervention
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University
Study officials:
affiliation: Vilnius University
name: Jonas Eimontas, PhD
role: STUDY_CHAIR
References: