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临床试验/NCT04396392
NCT04396392Unknown不适用

VR-based Training for Adolescents With Fear of Public Speaking, a Randomized Controlled Trial

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Change in Public Speaking Anxiety Scale

研究概览

简要总结

Public speaking anxiety (PSA) is a common anxiety with onset in adolescence and early adulthood. With the advent of consumer Virtual Reality (VR) technology, VR-delivered exposure therapy has previously been shown to be efficacious with adults. Virtual reality has existed for several decades, but it is only in the recent years it has become readily available. The new generation of off-the-shelf, consumer VR hardware, can revolutionize the design, availability and dissemination of VR therapist tools for exposure therapies. Importantly, there has been relatively little research on VR delivered exposure of anxiety in social situations compared to other anxiety disorders, presumably due to the complexity of the virtual stimuli required. There has been no study on VR delivered exposure specifically for adolescents until recently. A feasibility and pilot trial laying the foundation of the current study showed great potential in using VR for adolescents with PSA. The current study aims to investigate the efficacy of a self-guided VR intervention compared to a self-guided internet-delivered text-based intervention using a two-phased randomized design. Adolescents aged 13-16 will be invited to participate in the study

详细描述

The study is a two-phased intervention study .

Participants with PSA will be randomized into three self-guided intervention groups and one delayed waiting list group as follows:

Group 1: receiving VR intervention (3 weeks)

Group 2: receiving VR intervention (3 weeks) + text-based exposure program (T-B-Exp) (3 weeks)

Group 3: receiving text-based psychoeducation and exposure program (T-B PE + T-B Exp) (6 weeks)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 13-16, Symptoms of PSA, as defined by Public Speaking Anxiety Scale (PSAS) which leads to distress and / or negative consequences at school. Based on data from the feasibility study (Kahlon et.al 2019) the cut-off will be PSAS <

排除标准

  • •Current ongoing treatment for mental health problems (psychoactive medication/psychotherapy) impaired eyesight and lack of stereoscopic vision which cause difficulties in the VR experience and balance problems

研究组 & 干预措施

VR-based training

Experimental

receiving only VR intervention

干预措施: VR-based training (Behavioral)

text-based training

Active Comparator

receiving only text-based intervention

干预措施: VR-based training (Behavioral)

VR- and text-based training

Experimental

receiving both VR intervention and text-based intervention

干预措施: VR-based training (Behavioral)

waiting list

No Intervention

waiting list in phase 1 and text-based training after 3 weeks

结局指标

主要结局

Change in Public Speaking Anxiety Scale

时间窗: 18 months

A new, modern, reliable and valid self-rating scale (Bartholomay \& Houlihan, 2016). The PSAS features 17 items (5 of which are reverse-coded) covering cognitive, behavioral and physiological aspects of PSA. Since the PSAS features a full Likert item response format, it should be more sensitive to change than older rating scales such as the Personal Report of Confidence as a Speaker (Phillips, Jones, Rieger, \& Snell, 1997). Normative score data is however as of yet missing. This scale is translated into Norwegian according to scientific standards (back-translation.). Although intended for adults, the wording did not present any problem for adolescents in our feasibility study. lower score means lower symptom-leves

次要结局

  • Change in Social Phobia Scale(18 months)
  • Change in Catastrophic belief expectancy(18 months)
  • Change in Social Interaction Anxiety Scale(18 months)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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