跳至主要内容
临床试验/NCT03885414
NCT03885414已完成不适用

Virtual Reality Exposure Therapy for Public Speaking Anxiety: A Multiple-baseline Effectiveness Trial

Stockholm University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年1月14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
23
试验地点
2
主要终点
Change from baseline: Public Speaking Anxiety Scale

研究概览

简要总结

Virtual Reality exposure therapy (VRET) is an efficacious treatment for anxiety disorders but has yet to be implemented in regular care settings. This is arguably due to the limitations of the past generation of VR technology, which was expensive, inaccessible, cumbersome and hard to use. With the advent of consumer VR technology, VRET is now ready for implementation in regular care. This multiple-baseline trial will examine the effectiveness of VRET for public speaking anxiety (PSA) when delivered under real-world conditions at an ordinary, non-specialized mental health clinic, by clinical psychologist with only brief VRET training. Participants will either be self-referred specifically for this treatment, or come through ordinary clinical channels. Self-rated PSA will serve as primary outcome measure and will be measured three times prior to treatment (at screening and twice after a diagnostic screening telephone interview) , four times after onset, at the end of the treatment period, and three months after treatment.

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

入排标准

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

入选标准

  • Have substantial public speaking anxiety (PSAS >= 60)
  • Can travel to PBM clinic on one occasion and pay stipulated patient fee
  • Can speak and understand sufficient Swedish
  • Have stable access to the internet

排除标准

  • Deficits in sight or balance impacting the VR-experience
  • A severe psychiatric disorder better treated elsewhere, including current major depression, alcohol or drug abuse, bipolarity, psychosis or similar
  • Active psychopharmacological treatment, unless stable for last 3 months
  • Other ongoing psychological treatment

结局指标

主要结局

Change from baseline: Public Speaking Anxiety Scale

时间窗: Change from baseline: (1) five days after interview, (2) ten days after interview, (3) 7 days post-OST, (4) 14 days post-OST (5) 21 days post-OST (6) 28 days post-OST, (7) 35 days post-OST, (8) 125 days post-PST

Canonical total score will be used. Measure is self-rated, online. Swedish translation of the original PSAS (Bartholomay \& Houlihan, 2016)

次要结局

  • Change from baseline: Liebowitz Social Anxiety Scale Self-Report(Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST)
  • Change from baseline: Patient Health Questionnaire 9-item(Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST)
  • Change from baseline: Brunnsviken Brief Quality of life scale(Change from baseline: (1) 7 days post-OST, (4) 35 days post-OST, (5) 125 days post-PST)
  • Change from baseline: Brief Fear of Negative Evaluation Scale(Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST)
  • Change from baseline: Generalized Anxiety Disorder 7-item(Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST)

研究者

发起方
Stockholm University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Per Carlbring

Professor

Stockholm University

研究点 (2)

Loading locations...

相似试验