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Multisite Virtual Reality Intervention for Speech Anxiety

NCT ID: NCT06593847

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1542 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2025-07-23

Brief Summary

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Exposure-based cognitive behavior therapy is an efficacious treatment for speech anxiety and has been delivered effectively in a virtual reality (VR) environment. The present multicenter study (conducted through the Exposure Therapy Consortium) is designed to evaluate whether trait versus state positive affectivity is a more effective predictor of exposure therapy outcomes. Further, the investigators will examine whether the predictive significance of trait positive affectivity can be accounted for by examination of baseline levels of self-efficacy, hope, and optimism.

Detailed Description

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The goal of this multicenter clinical trial is to examine predictors of VR exposure therapy outcomes for college students with public speaking anxiety following a positive or negative mood induction. The overarching aim of the present study is to evaluate whether trait versus state positive affectivity is a more effective predictor of exposure therapy outcomes. Further, the investigators will examine whether the predictive significance of trait positive affectivity can be accounted for by examination of baseline levels of self-efficacy, hope, and optimism. State affect is manipulated at an experimental level with affect induction procedures; trait positive affectivity is measured at baseline.

The study involves three phases: (1) initial screening, (2) in-person assessment and brief exposure intervention for a subset of participants with elevated public speaking anxiety, and (3) a one-week follow-up assessment conducted online. Students who choose to participate and screen high on a public speaking anxiety scale will be assigned to a positive or negative mood induction condition prior to undergoing VR-based exposure therapy. Public speaking and social anxiety outcomes are measured immediately post-intervention and one week later. The one-week follow-up assessment represents the primary outcome.

Conditions

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Public Speaking Speech Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single session VR-based exposure therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participants are blind to the study hypothesis and outcomes are assessed by participant self-report.

Study Groups

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Positive or Negative Mood Induction via film clips

VR exposure is the only intervention, but the VR intervention is conducted following either positive or negative mood induction.

Group Type OTHER

Single-session VR exposure intervention

Intervention Type BEHAVIORAL

VR exposure is the only intervention, but the VR intervention is conducted following either positive or negative mood induction.

Interventions

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Single-session VR exposure intervention

VR exposure is the only intervention, but the VR intervention is conducted following either positive or negative mood induction.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self-report of 18 - 70 years of age
* Current student at a participating University
* Ability to read English to provide informed consent
* Familiarity with a computer keyboard and mouse or a touch screen device (e.g. phone, tablet).
* For Phase 2: speech anxiety scale score of ≥ 18 on the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)

Exclusion Criteria

* Previous participation (i.e., no participant may take the survey more than once).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role collaborator

Curtin University

OTHER

Sponsor Role collaborator

Erasmus University Rotterdam

OTHER

Sponsor Role collaborator

National University of Singapore

OTHER

Sponsor Role collaborator

Southern Illinois University

OTHER

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role collaborator

University of Western Sydney

OTHER

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role collaborator

Philipps Universität Marburg

UNKNOWN

Sponsor Role collaborator

Albright College

UNKNOWN

Sponsor Role collaborator

Utrecht University

OTHER

Sponsor Role collaborator

Boston University Charles River Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Otto, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

Southern Illinois University

Carbondale, Illinois, United States

Site Status

Tufts University

Boston, Massachusetts, United States

Site Status

Boston University

Boston, Massachusetts, United States

Site Status

Albright College

Reading, Pennsylvania, United States

Site Status

University of Texas at Austin

Austin, Texas, United States

Site Status

Western Sydney University

Penrith, New South Wales, Australia

Site Status

University of New South Wales

Sydney, New South Wales, Australia

Site Status

Curtin University

Bently, Western Australia, Australia

Site Status

University of Hong Kong

Pokfulam, Hong Kong, China

Site Status

Philipps-Universität Marburg

Marburg, Hesse, Germany

Site Status

Erasmus University

Rotterdam, South Holland, Netherlands

Site Status

Utrecht University

Utrecht, , Netherlands

Site Status

Countries

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United States Australia China Germany Netherlands

Related Links

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https://exposure.la.utexas.edu/

Exposure Therapy Consortium

Other Identifiers

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7565E

Identifier Type: -

Identifier Source: org_study_id