- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06086756
Virtual Reality Intervention for Speech Anxiety
The Influence of Mood on Response to Virtual Reality-Based Exposure for Public Speaking Anxiety
Study Overview
Status
Conditions
Detailed Description
The goal of this clinical trial is to compare outcomes of VR exposure therapy for college students with public speaking anxiety following a positive or negative mood induction. The overarching aim of the present study is to determine whether mood state prior to engaging in a brief VR exposure therapy session for public speaking anxiety impacts treatment outcomes.
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.
Researchers will compare participants given a positive mood induction to participants given a negative mood induction to see if public speaking anxiety outcomes differ.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elias Culver
- Phone Number: 2177190767
- Email: emculver@bu.edu
Study Contact Backup
- Name: Michael Otto, PhD
- Phone Number: 6173539610
- Email: mwotto@bu.edu
Study Locations
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-
Massachusetts
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Boston, Massachusetts, United States, 02215
- Center for Anxiety and Related Disorders
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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 years of age or older
- Current student at Boston 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 ≥ 14 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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Positive Mood Induction via positive film clips
The standardized procedures outlined in our laboratory's previously conducted study (Stathopoulou, Pollack, & Otto, 2018) will be followed.
Participants will be presented with two brief film clips on a computer monitor or TV screen.
These film clips were selected to elicit positive affect.
As utilized in past lab study procedures, participants will be asked to: "Let yourself experience whatever emotions you have, as fully as you can.
Don't try to hold back, or hold in, your feelings" (Stathopoulou, Pollack, & Otto, 2018).
Together, the two film clips will last for approximately 5 minutes.
|
Positive mood induction followed by a brief VR exposure session for public speaking anxiety.
|
Experimental: Negative Mood Induction via negative film clips
The standardized procedures outlined in our laboratory's previously conducted study (Stathopoulou, Pollack, & Otto, 2018) will be followed.
Participants will be presented with two brief film clips on a computer monitor or TV screen.
These film clips were selected to elicit negative affect.
As utilized in past lab study procedures, participants will be asked to: "Let yourself experience whatever emotions you have, as fully as you can.
Don't try to hold back, or hold in, your feelings" (Stathopoulou, Pollack, & Otto, 2018).
Together, the two film clips will last for approximately 5 minutes.
|
Negative mood induction followed by a brief VR exposure session for public speaking anxiety.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Public Speaking Anxiety
Time Frame: Comparison of pre-exposure scores to scores from post-treatment, approximately 2 week post-screen
|
Assessed using the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)
|
Comparison of pre-exposure scores to scores from post-treatment, approximately 2 week post-screen
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Valence
Time Frame: Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
|
Self-report measure of how participant feels about having to give a speech
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Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
|
Social Phobia
Time Frame: Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
|
Assessed using the social phobia inventory (SPIN)
|
Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
|
Public Speaking Anxiety
Time Frame: Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
|
Assessed using the PRCA-PS
|
Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elias Culver, Boston University
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7164E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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