NCT06214039

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Feb 2024May 2026

First Submitted

Initial submission to the registry

December 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

February 14, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Expected
Last Updated

May 24, 2024

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

December 18, 2023

Last Update Submit

May 23, 2024

Conditions

Keywords

public speaking anxietyvirtual realitysocial anxietypsychological interventionexposure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Liebowitz Social Anxiety Scale - Self-Report (LSAS-SR), (Liebowitz, 2003; Rytwinski et al., 2009)

    Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment

  • Brief Fear of Negative Evaluation Scale (BFNE), (Leary, 1983)

    Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment

  • Igroup Presence Questionnaire (IPQ)

    Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment

  • Patient health questionnaire - 9 (PHQ-9), (Spitzer et al., 1999)

    Pre-treatment, mid-treatment, immediately after the intervention, 3 and 12 months post-treatment

Other Outcomes (1)

  • Subjective Units of Distress (SUD)

    Pre-intervention, immediately after the intervention

Study Arms (2)

One session therapy

ACTIVE COMPARATOR

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

One session therapy - divided into 3

EXPERIMENTAL

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

Interventions

A 3-hour one session exposure therapy for public speaking anxiety

One session therapyOne session therapy - divided into 3

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University

Vilnius, LT-01513, Lithuania

RECRUITING

Study Officials

  • Jonas Eimontas, PhD

    Vilnius University

    STUDY CHAIR

Central Study Contacts

Jonas Eimontas, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 19, 2024

Study Start

February 14, 2024

Primary Completion

May 1, 2025

Study Completion (Estimated)

May 1, 2026

Last Updated

May 24, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Following the publication of the trial results.
Access Criteria
Available to researchers affiliated with research institutions upon a reasonable request.
More information

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