Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06086756
Other study ID # 7164E
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date December 5, 2023

Study information

Verified date December 2023
Source Boston University Charles River Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 5, 2023
Est. primary completion date December 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exposure intervention plus positive mood induction
Positive mood induction followed by a brief VR exposure session for public speaking anxiety.
Exposure intervention plus negative mood induction
Negative mood induction followed by a brief VR exposure session for public speaking anxiety.

Locations

Country Name City State
United States Center for Anxiety and Related Disorders Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Public Speaking Anxiety 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 Valence Self-report measure of how participant feels about having to give a speech Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
Secondary Social Phobia Assessed using the social phobia inventory (SPIN) Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
Secondary Public Speaking Anxiety Assessed using the PRCA-PS Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04391530 - The Effect of Breath Therapy and Emotional Freedom Technique on Public Speaking Anxiety N/A
Completed NCT03885414 - Virtual Reality Exposure Therapy for Public Speaking Anxiety N/A
Completed NCT00842946 - Exposure With Acceptance-Based Versus Habituation-Based Rationale for Public Speaking Anxiety N/A