Clinical trial NCT06593847: Multisite Virtual Reality Intervention for Speech Anxiety
Official title: Multisite Virtual Reality Intervention for Speech Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Public Speaking
Speech Anxiety
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
name: Curtin University
name: Erasmus University Rotterdam
name: National University of Singapore
name: Southern Illinois University
name: Tufts University
name: The University of New South Wales
name: University of Western Sydney
name: University of Arizona
name: The University of Hong Kong
name: Philipps Universität Marburg
name: Albright College
name: Utrecht University
First posted: 2024-09-19
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single session VR-based exposure therapy
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Public Speaking Anxiety
timeFrame: One week follow-up assessment
Secondary outcomes:
measure: Valence
timeFrame: One week follow-up assessment
measure: Assessed using the Social Phobia Inventory (SPIN)
timeFrame: One week follow-up assessment
measure: Public Speaking Anxiety
timeFrame: Post-treatment assessment immediately after the intervention
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Carbondale
country: United States
facility: Southern Illinois University
state: Illinois
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Reading
country: United States
facility: Albright College
state: Pennsylvania
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
city: Penrith
country: Australia
facility: Western Sydney University
state: New South Wales
city: Sydney
country: Australia
facility: University of New South Wales
state: New South Wales
city: Bently
country: Australia
facility: Curtin University
state: Western Australia
city: Pokfulam
country: China
facility: University of Hong Kong
state: Hong Kong
city: Marburg
country: Germany
facility: Philipps-Universität Marburg
state: Hesse
city: Rotterdam
country: Netherlands
facility: Erasmus University
state: South Holland
city: Utrecht
country: Netherlands
facility: Utrecht University
Study officials:
affiliation: Boston University
name: Michael Otto, PhD
role: PRINCIPAL_INVESTIGATOR
References: