- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06593847
Multisite Virtual Reality Intervention for Speech Anxiety (ETC2)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New South Wales
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Penrith, New South Wales, Australia, 2751
- Western Sydney University
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Sydney, New South Wales, Australia, 2052
- University of New South Wales
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Western Australia
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Bently, Western Australia, Australia, 6102
- Curtin University
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Hong Kong
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Pokfulam, Hong Kong, China
- University of Hong Kong
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Hesse
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Marburg, Hesse, Germany, 35037
- Philipps-Universität Marburg
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Utrecht, Netherlands, 3584 CS
- Utrecht University
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South Holland
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Rotterdam, South Holland, Netherlands, 3062 PA
- Erasmus University
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Arizona
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Tucson, Arizona, United States, 85721
- University of Arizona
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Illinois
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Carbondale, Illinois, United States, 62901
- Southern Illinois University
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Boston University
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Boston, Massachusetts, United States, 02155
- Tufts University
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Pennsylvania
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Reading, Pennsylvania, United States, 19604
- Albright College
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Texas
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Austin, Texas, United States, 78712
- University of Texas at Austin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: 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.
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VR exposure is the only intervention, but the VR intervention is conducted following either positive or negative mood induction.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Public Speaking Anxiety
Time Frame: One week follow-up assessment
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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.
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One week follow-up assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Valence
Time Frame: One week follow-up assessment
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Self-report measure of how participant feels about having to give a speech
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One week follow-up assessment
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Assessed using the Social Phobia Inventory (SPIN)
Time Frame: One week follow-up assessment
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Assessed using the Social Phobia Inventory (SPIN).
Scores range from 0-68, with higher scores indicating greater social phobia.
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One week follow-up assessment
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Public Speaking Anxiety
Time Frame: Post-treatment assessment immediately after the intervention
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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.
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Post-treatment assessment immediately after the intervention
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael Otto, PhD, Boston University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7565E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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