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临床试验/NCT02379949
NCT02379949已完成不适用

Virtual Reality Exposure Therapy for the Treatment of Social Phobia

Georgia State University2 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2004年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
2
主要终点
Personal Report of Confidence as a Speaker

研究概览

简要总结

This randomized clinical trial compares virtual reality exposure therapy to exposure group therapy to a waiting list control group.

详细描述

Virtual reality exposure therapy (VRE) for the treatment of anxiety disorders has received considerable attention. During VRE, a person encounters a feared stimulus in a computer-generated environment, often through the use of a head mounted display and motion tracker that allows for multisensory input and natural movement. Several advantages of VRE have been noted - both clinical, such as treatment acceptability, and methodological, such as the ability to conduct exposure in a tightly controlled environment. Empirical support for VRE varies across anxiety disorders. Specifically, randomized controlled trials support the efficacy of VRE with fear of flying and acrophobia and show that it is equally effective as in vivo exposure. These phobias lend themselves well to VRE; the feared stimulus is circumscribed and contains powerful physical cues that can be produced within a virtual environment. There is less controlled research on the use of VRE for other anxiety disorders. The current study examines VRE for social anxiety disorder, which is characterized by fear of negative evaluation, and thus may be more difficult to evoke and treat using a virtual environment. Further, no research to date has compared VRE and the gold standard treatment for social anxiety disorder - cognitive behavioral therapy in a group format.

The purpose of the current study is to compare VRE and Exposure Group Therapy to wait list in a sample of adults meeting criteria for social anxiety disorder with a primary fear of public speaking. It is hypothesized that, relative to wait list, those receiving treatment will improve on standardized measures of public speaking fears and fears of negative evaluation, as well as a behavioral avoidance task. Participants also are expected to maintain treatment gains at 3 and 12-month follow-up. Comparisons between the two active treatments also will be made.

Procedure

Following consent, study candidates completed a phone interview to screen for obvious exclusion criteria (e.g., current treatment for social anxiety disorder) and then an in-person, pretreatment assessment consisting of the Structured Clinical Interview for the DSM-IV (SCID), speech task, and the battery of self-report measures. Eligible participants were randomly assigned to virtual reality exposure therapy, exposure group therapy, or wait list by simple randomization using a computerized random number generator. Concealment procedures were used to prevent foreknowledge of treatment assignment from influencing enrollment. Each potential participant had a participant number, which was only known by the study coordinator. The first author kept a hard copy of a list linking participant number to condition assignment in a locked file drawer. Once a participant was enrolled, the study coordinator asked for the treatment condition for a particular participant number. The first author had no knowledge of which participant was linked with a participant number, and the study coordinator had no knowledge of which participant number was linked with treatment condition. Participants assigned to wait list were re-randomized to virtual reality exposure therapy or exposure group therapy following the waiting period (Figure 1). Participants completed all assessment and treatment sessions at a psychology clinic within at an urban research university that is accessible by public transportation.

Assessments

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Speakers of English meeting DSM-IV (APA, 2000) criteria for a primary diagnosis of social anxiety disorder
  • Self-identifying public speaking as their primary social fear
  • Participants were required to be stabilized on psychoactive medication(s) and dosage(s) for 3 months.

排除标准

  • history of mania, schizophrenia, or psychosis
  • current suicidal ideation, alcohol, or substance dependence
  • inability to tolerate the virtual reality helmet/environment
  • history of seizures
  • concurrent psychotherapy for social anxiety disorder

结局指标

主要结局

Personal Report of Confidence as a Speaker

时间窗: 12 months following final treatment session

30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.

Fear of Negative Evaluation-Brief Form

时间窗: 12 months following final treatment session

12-item questionnaire measuring the degree to which individuals fear being negatively evaluated by others across a number of social settings.

Clinician Global Impressions of Improvement

时间窗: 12 months following final treatment session

The behavioral avoidance test was based on a standardized speech assessment protocol (Beidel, Turner, Jacob, \& Cooley, 1989), in which participants are given 3 min to prepare notes on five controversial topics (e.g., abortion, same-sex marriage). Participants are then asked to speak for 10 min on up to three topics and to rate how well they performed (0 -10) and how anxious they felt (0 -10), with higher numbers indicating better performance and higher anxiety. Audience members consisted of two to four trained undergraduate or graduate students; the therapist was never an audience member.

Behavioral Avoidance Test

时间窗: 12 months following final treatment session

The behavioral avoidance test was based on a standardized speech assessment protocol (Beidel, Turner, Jacob, \& Cooley, 1989), in which participants are given 3 min to prepare notes on five controversial topics (e.g., abortion, same-sex marriage). Participants are then asked to speak for 10 min on up to three topics and to rate how well they performed (0 -10) and how anxious they felt (0 -10), with higher numbers indicating better performance and higher anxiety. Audience members consisted of two to four trained undergraduate or graduate students; the therapist was never an audience member.

次要结局

未报告次要终点

研究者

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

Page Anderson

Associate Professor

Georgia State University

研究点 (2)

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