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临床试验/NCT03973541
NCT03973541已完成不适用

EXPOSURE IN VIRTUAL REALITY FOR SOCIAL ANXIETY DISORDER - A Randomized Controlled Superiority Trial Comparing Cognitive Behavioral Therapy With Virtual Reality Based Exposure to Cognitive Behavioral Therapy With in Vivo Exposure.

Region of Southern Denmark2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2019年12月1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
51
试验地点
2
主要终点
change in Social Interaction Anxiety Scale (SIAS)

研究概览

简要总结

Social Anxiety Disorder (SAD) is classified as a phobic (anxious) disorder in which the patient experiences anxiety in social interactions, during which he or she might be judged or socially evaluated by others. SAD has an estimated lifetime prevalence of 3-13%, but remains under-treated. The recommended psychological treatment for SAD is is the exposure technique imbedded in Cognitive Behavioral Therapy (CBT). Traditionally exposure has taken place either in vivo or through imaginary exposure. In vivo has shown to be most effective, but it is costly and time-consuming and situational elements, such as the reaction of others, are difficult to control. Recently, researchers and clinicians have started to use Virtual Reality (VR) to overcome such difficulties. Compared to traditional methods VR-based Exposure has several advantages mainly based on increased control.

Meta-analyzes have found superior effect of CBT with VR-based Exposure compared to imaginary exposure, and similar effects when compared to in vivo exposure, with a recent study finding superior effect of VR-based Exposure compared to in vivo. The current evidence thus supports the clinical efficacy of CBT with VR-based Exposure. However, the meta-analyzes include a total of only six randomized controlled trials (RCTs) and only four of these compare CBT with VR-based Exposure to both an in vivo and a control group.

The aims of the current study are to develop a complete program of CBT with VR exposure based on 360° videos for adults suffering from SAD, and to evaluate the treatment effect on SAD symptoms.

The study is designed as a three arm RCT comparing 1) a group receiving CBT with VR-based Exposure, 2) a group receiving CBT with in vivo exposure and 3) a group receiving VR relaxation.

CBT with VR-based Exposure, will include 360° videos with three different scenarios In Vivo Exposure Therapy consists of role-playing and guided exposure either inside or outside the therapist's office.

VR Relaxation Therapy consists of a VR scenario of swimming with dolphins. Treatment will last 10 weeks and there will be a 6 months follow-up.

. It is hypothesized that

  • CBT with VR-based Exposure will reduce symptoms of SAD
  • CBT with VR-based Exposure will be more effective than both CBT with in vivo exposure and VR relaxation therapy at the end of treatment
  • An effect on symptom reduction will sustain at the 6 months follow-up

详细描述

Introduction Social Anxiety Disorder (SAD) is a common yet underreported mental disorder with an estimated lifetime prevalence of 3-13%, and low rates of spontaneous remission. Patients with SAD experience intense and persistent fear in social interactions, during which he or she might be judged or negatively evaluated by others (e.g. public speaking, shopping). Symptoms include overwhelming bodily symptoms, such as sweating, trembling and increased heart rate, leading to avoidance of social situations (e.g. education, work) and significant functional impairment. SAD is highly debilitating, with the majority of socially anxious persons reporting numerous problems in individual and social adjustment, and with associated impairment in academic and professional functioning. Moreover, SAD often co-occurs with other psychiatric conditions such as mood disorders and substance use disorders, and is significantly associated with suicidal ideation. Despite its frequency and severity, only between one third and half of people with SAD seek treatment.

The recommended psychological treatment for SAD is the exposure technique imbedded in Cognitive Behavioral Therapy (CBT). CBT for SAD combines cognitive restructuring with exposure. In exposure-based therapy, exposures to social situations are used to test the patient's predictions about the danger in a particular situation. Further, it helps the patient develop new, realistic mental representations associated with the feared stimuli. Patients with SAD often have excessively high standards for social performance, and a strong fear of ridicule. Thus, it can be particularly helpful to encourage patients to behave in ways that they would consider unacceptable. i.e. intentionally acts against their excessively rigid rules for social interaction while observing the consequences.

Exposure has traditionally taken place as either:

  1. In vivo: directly facing the feared situation.
  2. Imaginary exposure: imagining the feared situation (can be facilitated through pictures or videos).

In vivo exposure is effective, but is costly, time-consuming and situational elements, such as the reaction of others, are difficult to control. Furthermore, many patients are rather unwilling to expose themselves to the real situation since it is considered too frightening. Furthermore, there is a risk of encountering familiar people revealing that the person is in therapy. Conversely, imaginary exposure may lack realism and intensity , and can be difficult for people who are unable to imagine vividly, avoid imagining their phobia-inducing situations, or tend to overwhelm themselves with images. Recently, researchers and clinicians have started to use Virtual Reality (VR) to overcome these difficulties.

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

盲法说明

Assignment will be kept blind for participants and clinicians until the first exposure session.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to comprehend the Danish language
  • ≥18 years
  • Fulfill the diagnostic criteria for SAD according to ICD-10 (F40.1) or ICD-11 (6B04)

排除标准

  • Previously diagnosed with psychosis, Autism Spectrum Disorder or severe depression.
  • Participating in other psychotherapeutic treatments during the study
  • Substance dependence disorder
  • Severe cyber-sickness (corresponding to driving sickness).
  • If on medication, medication must be stable for 6 months prior to the study and during the study (i.e., no change).

结局指标

主要结局

change in Social Interaction Anxiety Scale (SIAS)

时间窗: change from baseline to week 10

Severity of Social Anxiety Disorder. SIAS is a measure of anxiety in social interactional situations and consist of 20 items scored 0-4. The total score range from 0-80 with a score higher than 43 indicating that SAD is probable

次要结局

  • change in EQ-5D-5L(change from baseline to week 10)
  • The Working Alliance Inventory-Short Revised (WAI-SR)(week 10)
  • Specific Work for Exposure Applied in Therapy (SWEAT).(week 10)

研究者

发起方
Region of Southern Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Per T Ørskov

PhD

Region of Southern Denmark

研究点 (2)

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