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Virtual Reality Intervention for Speech Anxiety

Primary Purpose

Public Speaking, Speech Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exposure intervention plus positive mood induction
Exposure intervention plus negative mood induction
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Public Speaking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Positive Mood Induction via positive film clips

    Negative Mood Induction via negative film clips

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Public Speaking Anxiety
    Assessed using the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)

    Secondary Outcome Measures

    Valence
    Self-report measure of how participant feels about having to give a speech
    Social Phobia
    Assessed using the social phobia inventory (SPIN)
    Public Speaking Anxiety
    Assessed using the PRCA-PS

    Full Information

    First Posted
    October 2, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Boston University Charles River Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06086756
    Brief Title
    Virtual Reality Intervention for Speech Anxiety
    Official Title
    The Influence of Mood on Response to Virtual Reality-Based Exposure for Public Speaking Anxiety
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    January 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boston University Charles River Campus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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 study is designed to evaluate whether mood state moderates outcome to a brief VR exposure intervention.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Public Speaking, Speech Anxiety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Positive Mood Induction via positive film clips
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Negative Mood Induction via negative film clips
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exposure intervention plus positive mood induction
    Intervention Description
    Positive mood induction followed by a brief VR exposure session for public speaking anxiety.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exposure intervention plus negative mood induction
    Intervention Description
    Negative mood induction followed by a brief VR exposure session for public speaking anxiety.
    Primary Outcome Measure Information:
    Title
    Public Speaking Anxiety
    Description
    Assessed using the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)
    Time Frame
    Comparison of pre-exposure scores to scores from post-treatment, approximately 1 week post-screen
    Secondary Outcome Measure Information:
    Title
    Valence
    Description
    Self-report measure of how participant feels about having to give a speech
    Time Frame
    Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
    Title
    Social Phobia
    Description
    Assessed using the social phobia inventory (SPIN)
    Time Frame
    Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
    Title
    Public Speaking Anxiety
    Description
    Assessed using the PRCA-PS
    Time Frame
    Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elias Culver
    Phone
    2177190767
    Email
    emculver@bu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Otto, PhD
    Phone
    6173539610
    Email
    mwotto@bu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elias Culver
    Organizational Affiliation
    Boston University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Virtual Reality Intervention for Speech Anxiety

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