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临床试验/NCT06593847
NCT06593847已完成不适用

Multisite Virtual Reality Intervention for Speech Anxiety

Boston University Charles River Campus25 个研究点 分布在 5 个国家目标入组 1,542 人开始时间: 2024年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,542
试验地点
25
主要终点
Public Speaking Anxiety

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Participants are blind to the study hypothesis and outcomes are assessed by participant self-report.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Previous participation (i.e., no participant may take the survey more than once).

结局指标

主要结局

Public Speaking Anxiety

时间窗: One week follow-up assessment

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.

次要结局

  • Valence(One week follow-up assessment)
  • Assessed using the Social Phobia Inventory (SPIN)(One week follow-up assessment)
  • Public Speaking Anxiety(Post-treatment assessment immediately after the intervention)

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Sponsor

研究点 (25)

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