NCT06593847

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,542

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
5 countries

13 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

October 8, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

September 3, 2024

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Public Speaking Anxiety

    Assessed using the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS). Scores range from 6 to 30, with higher scores associated with higher public speaking anxiety.

    One week follow-up assessment

Secondary Outcomes (3)

  • Valence

    One week follow-up assessment

  • Assessed using the Social Phobia Inventory (SPIN)

    One week follow-up assessment

  • Public Speaking Anxiety

    Post-treatment assessment immediately after the intervention

Study Arms (1)

Positive or Negative Mood Induction via film clips

OTHER

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

Behavioral: Single-session VR exposure intervention

Interventions

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

Positive or Negative Mood Induction via film clips

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Previous participation (i.e., no participant may take the survey more than once).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Arizona

Tucson, Arizona, 85721, United States

Location

Southern Illinois University

Carbondale, Illinois, 62901, United States

Location

Tufts University

Boston, Massachusetts, 02155, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

Albright College

Reading, Pennsylvania, 19604, United States

Location

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Western Sydney University

Penrith, New South Wales, 2751, Australia

Location

University of New South Wales

Sydney, New South Wales, 2052, Australia

Location

Curtin University

Bently, Western Australia, 6102, Australia

Location

University of Hong Kong

Pokfulam, Hong Kong, China

Location

Philipps-Universität Marburg

Marburg, Hesse, 35037, Germany

Location

Erasmus University

Rotterdam, South Holland, 3062 PA, Netherlands

Location

Utrecht University

Utrecht, 3584 CS, Netherlands

Location

Related Links

MeSH Terms

Conditions

SpeechGlossophobia

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Study Officials

  • Michael Otto, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants are blind to the study hypothesis and outcomes are assessed by participant self-report.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single session VR-based exposure therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 19, 2024

Study Start

October 8, 2024

Primary Completion

July 23, 2025

Study Completion

July 23, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Data will be posted on the Open Science Foundation site.

Shared Documents
STUDY PROTOCOL
Time Frame
Within one year of study completion.
Access Criteria
Via request to the Exposure Therapy Consortium
More information

Locations