跳至主要内容
临床试验/NCT03135990
NCT03135990终止不适用

Using Virtual Reality in Exposure-Based Treatment for Social Anxiety in Youth

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
19
试验地点
1
主要终点
Change in diagnostic in diagnostic status and severity of social anxiety symptoms measured by ADIS

研究概览

简要总结

Anxiety disorders are the most common mental health diagnosis in the US and are associated with avoidance that causes functional impairments and decreases quality of life. Social anxiety disorder is among the most prevalent anxiety disorders, with most common age of onset being in adolescence. The frontline treatment for social anxiety disorder is cognitive behavioral therapy with exposure. However, a significant number of adolescent patients do not get better after completing cognitive behavioral therapy or experience relapse. This could be explained by findings in both mice and humans suggesting that cue-based extinction learning occurs less readily in adolescents than in children and adults. Studies using mouse-models have overcome this age disparity by enhancing contextual cues when fear extinction learning takes place. Providing realistic learning contexts for exposure could be the key to enhancing treatment effects in adolescents. This is often challenging for a variety of reasons, including difficulty realistically mimicking anxiety-provoking social situations due to limited resources, clinician training, time, or motivation. Virtual reality environments could provide contextual exposures for social anxiety.

This pilot study will test the feasibility of integrating virtual reality technology in exposure-based treatment in youth ages 13-23 diagnosed with social anxiety disorder with the goal of approximating equivalent efficacy with traditional cognitive behavioral therapy, and assessing feasibility of virtual reality technology with this population. We will also pilot a fear conditioning and extinction learning paradigm to explore the relationship between extinction learning and efficacy of virtual reality exposure therapy, using physiological assessment indicators to mark changes in fear response. These markers will also be used prior to the initiation of the therapy to assess the degree to which virtual reality environments invoke a true fear response, comparing the 12 participants with social phobia to 12 age matched, non-anxious control participants. The aims of this study are threefold: to assess feasibility of using virtual reality in treatment of social anxiety in youth, to examine whether virtual reality invokes arousal similar to anxiety and test the physiological assessment protocol, and to evaluate whether exposure using virtual reality environments reduces symptoms of social anxiety and related functional impairment.

详细描述

Lifetime prevalence of social anxiety disorder in adolescents is estimated to be 8.6%, with the most common age of onset being ages 15-17. Social anxiety disorder is related to significant functional impairment and, if untreated, puts youth at risk for depression and substance abuse, and results in failure to meet important academic, social, and occupational milestones. The current literature supports cognitive behavioral therapy with exposure therapy, selective serotonin re-uptake inhibitor medications, and their combination for the treatment of anxiety disorders with good effects. However, even with gold standard treatment, a significant number of patients do not get better or experience relapse. Exposure therapy is based on the principles of fear extinction, such that cues associated with threat are presented in a safe and controlled way until they are experienced as safe and fear responses are reduced. Studies in mice and non-anxious humans have demonstrated cue-based fear extinction learning to be less robust in adolescence than it is in childhood or adulthood. However, mouse-models suggest that context-based extinction learning closes the gap between age-groups, with adolescents performing as well on extinction learning tasks when put back in the original environment where the fear was acquired.

Similarly, clinical research suggest that exposure therapy is most useful when exposures are conducted in the same or similar environments to where the fear is experienced in everyday life. However, there are many barriers to providing contextual based exposure therapy, particularly for social anxiety, including paucity of well-trained exposure therapists in many areas of the country, and difficulty generating or accessing realistic social situations for convincing exposures.

Virtual reality offers a promising avenue for contextual exposures, by increasing the availability of certain contexts that cannot be readily mimicked in therapy. Furthermore, in vivo exposure situations can feel overwhelming for some individuals (patients and therapists), resulting in refusal to engage in exposure altogether. Virtual reality technology could allow for more gradual titration of exposure for those patients that require lower intensity exposures, and can be done in the therapy office for clinicians who do not have the time, resources, experience, or comfort level to travel outside of their office in pursuit of appropriate exposure environments. Even for seasoned exposure therapists, virtual reality could serve as a practice step in preparation for in vivo exposures or could be used in lieu of in vivo exposures if necessary. There has been extensive research on the use of virtual reality in facilitating exposure in a variety of populations. However, its effectiveness has not been demonstrated in adolescents with social phobia, and research is limited in adolescent samples in general.

The pilot study proposed for this National Alliance for Research on Schizophrenia and Depression award would test the overall hypothesis that virtual reality technology is feasible, acceptable, and will enhance exposure-based therapy for socially anxious youth. Studies will be focused on testing the feasibility of integrating virtual reality technology into exposure-based treatment in adolescents and young adults (ages 13-23) diagnosed with social anxiety disorder with the goal of approximating equivalent efficacy with traditional cognitive behavioral therapy, and assessing feasibility, usability, and acceptability of the virtual reality technology with this population. In addition, we would pilot a fear conditioning and extinction learning paradigm with the subjects to explore the relationship between extinction learning and efficacy of virtual reality exposure therapy, using physiological assessment indicators to mark changes in fear response, including skin conductance, heart rate, heart rate variability, and startle. These physiological markers would also be used prior to the initiation of the therapy to assess the degree to which the virtual reality environments invoke a true fear response, comparing the 12 subjects with social phobia to 12 age-matched, non-anxious control subjects. If feasible and effective, these procedures would be used for a larger future study, and pilot data would be used for a K-award, R21, or R01 grant application, including neuroimaging to learn more about the neural circuitry involved in fear learning via virtual reality technology.

SPECIFIC AIMS

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
13 Years 至 23 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Unable to consent.
  • A prior or present diagnosis of receptive and expressive language disorder and/or pervasive developmental disorder or severe mental retardation.
  • Current substance use disorder or dependence as primary diagnosis.
  • Recent suicide behavior (last month) or any other psychiatric condition that requires more intensive care (e.g., psychotic episode, manic episode).
  • Youth or parent/third party not fluent in English.

结局指标

主要结局

Change in diagnostic in diagnostic status and severity of social anxiety symptoms measured by ADIS

时间窗: Initial Visit,Immediately after the intervention, and Three Month Follow Up Visit

Anxiety Disorders Interview Schedule is used to assess change in diagnostic status and severity of social anxiety symptoms. A low score of a 3 or below would be a sub-clinical representation of the disorder, a 4 represent moderate severity and a high score of 5-8 would be a clinically severe representation of the disorder.

次要结局

  • Change in depression and suicidality as measured by CESD-R(Initial Visit, Immediately after the intervention, and Three Month Follow Up Visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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