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临床试验/NCT05319509
NCT05319509招募中不适用

Pilot Study of Virtual Reality Therapy for Students With Anxiety

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Change in anxiety related behaviors such as volume of speech

研究概览

简要总结

The purpose of this study is to assess changes in self-reported anxiety over the course of six virtual reality (VR) sessions and to assess changes in academic self-efficacy, as well as examine the feasibility and acceptability of a relatively short and time intensive VR intervention (i.e.,six sessions over the course of three weeks) for reducing anxiety symptoms in college students.

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 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • enrolled in The University of Texas Health Science Center School of Public Health San Antonio regional campus
  • competent in English
  • total score of at least 3 on the Generalized Anxiety Disorder (GAD-2)

排除标准

  • Currently receiving psychological treatment for anxiety symptoms, or has received treatment in the last year.
  • Report photosensitive epilepsy.
  • Report stereoscopic vision or balance problems

结局指标

主要结局

Change in anxiety related behaviors such as volume of speech

时间窗: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)

Anxiety-related behaviors will be recorded using an event sampling observation guide

Change in Psychomotor agitation such as pacing

时间窗: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)

Anxiety-related behaviors will be recorded using an event sampling observation guide

Change in state anxiety as assessed by the Liebowitz Social Anxiety Scale-Self Report version (LSAS-SR)

时间窗: before first session in week 1, before third session in week 2 and before sixth session in week 3

The LSAS-SR questionnaire is composed of 24 items divided into 2 subscales, 13 concerning performance anxiety, and 11 pertaining to social situations. The 24 items are first rated on a Likert Scale from 0(none) to 3(severe) on fear felt during the situations, and then the same items are rated from 0(never)-3(usually)regarding avoidance of the situation. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points. Score of 30 or less indicates social anxiety disorder(SAD) is unlikely, score of 30-60 shows that SAD is probable and score 60-90 indicates that SAD is highly probable.

Change in anxiety related behaviors such as Utterances about experience

时间窗: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)

Anxiety-related behaviors will be recorded using an event sampling observation guide

Change in Psychomotor agitation such as Rubbing hands/neck/head

时间窗: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)

Anxiety-related behaviors will be recorded using an event sampling observation guide

Change in Psychomotor agitation such as Fidgeting

时间窗: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)

Anxiety-related behaviors will be recorded using an event sampling observation guide

Change in depressive symptoms as assessed by score on the Patient Health Questionnaire-4 (PHQ-4)

时间窗: Baseline(before the first session in week 1)

The PHQ-4 questionnaire consists of 4 questions and each is rated on a 4 point scale from 0(not at all) to 3(every day) for a maximum score of 12,a higher number indicating a worse outcome.

Change in anxiety related behaviors such as rate of speech

时间窗: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)

Anxiety-related behaviors will be recorded using an event sampling observation guide

Change in anxiety related behaviors such as Negative self-talk

时间窗: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)

Anxiety-related behaviors will be recorded using an event sampling observation guide

Change in anxiety related behaviors such as Laughter

时间窗: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)

Anxiety-related behaviors will be recorded using an event sampling observation guide

Change in physiology such as perspiration

时间窗: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)

Anxiety-related behaviors will be recorded using an event sampling observation guide

次要结局

  • Change in acceptability as assessed by the rating on a short questionnaire(after the third session in week 2 , after sixth session in week 3)
  • Change in perceived presence in the virtual environment (as indicated by continuous score on the Igroup Presence Questionnaire (IPQ)(after the third session in week 2 and the sixth session in week 3)
  • change in feasibility as assessed by the rating on a short questionnaire(after the third session in week 2 , after sixth session in week 3)
  • Change in self-reported academic performance as assessed by the Motivated Strategies for Learning Questionnaire (MSLQ)(before first session in week 1, before third session in week 2 and before sixth session in week 3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jack Tsai

Professor

The University of Texas Health Science Center, Houston

研究点 (2)

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