Virtual Reality for AnxIety Disorders - Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Social Anxiety Interaction Scale
研究概览
简要总结
Social anxiety disorder (SAD) has a high prevalence and an early onset and has a lengthy recovery period often taking decades to occur. Current evidence supports the efficacy of cognitive behavioral therapy (CBT) with virtual reality (VR) exposure. However, the evidence is based on a small number of studies.
This trial examines the efficacy of an intervention that combines CBT with individually tailored exposure in VR. During exposure, participants' anxiety level is estimated in real time based on heart rate and electrodermal activity. Estimated anxiety level can guide the therapist's adjustment of the VR content. The above treatment is compared with the gold standard treatment for SAD which is cognitive behavioral therapy with exposure conducted in real life. Treatment is individual, manual-based and consists of 10 weekly sessions with a duration of 60 minutes.
The aim of the study is to investigate whether CBT combined with exposure in VR (adapted on the basis of estimated anxiety level) is more effective than CBT with exposure in real life.
The trial is a randomized controlled trail (RCT). The study includes 90 participants diagnosed with SAD. Assessments are carried out pre-treatment, mid-treatment and at follow-up (6 and 12 months).
The primary outcome of the study is self-reported symptoms of social anxiety using Social Interaction Anxiety Scale. The primary endpoint is post-treatment.
详细描述
INTRODUCTION
Social anxiety disorder (SAD) is a common anxiety disorder characterized by excessive fear of being scrutinized or criticized by others leading to avoidance of social situations. According to the ICD-10 classification of mental and behavioral disorders, engaging in feared situations is accompanied by autonomic symptoms of anxiety such as sweating, trembling or increased heartrate (HR). The lifetime prevalence of SAD ranges between 8.4% and 12.1% and the 12 month prevalence ranges between 4.2% and 7.1%.
SAD is related to reduced health-related quality of life and is also associated with substantial psychiatric comorbidity including other anxiety disorders, mood disorders and substance use disorders. Epidemiological studies show that SAD most often precedes depression and that SAD is related to a substantially and consistently increase in risk of subsequent depression. Similarly, symptoms of social anxiety often precedes alcohol dependence.
SAD is an adolescent-onset disorder with a long recovery period. Despite the prolonged recovery, few individuals with SAD seek treatment for their disorder. Only about one-third of lifetime cases report ever seeking treatment for SAD. Not seeking treatment may be related to the nature of the disorder itself. Individuals with SAD avoid treatment because the treatment itself constitutes a social situation that provokes anxiety.
The treatment of choice for social anxiety is cognitive behavioral therapy (CBT). Treatment is conducted both individually and in group-settings. Exposure therapy is central to CBT and is very effective in fear reduction.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sufficient knowledge of the Danish Language.
- •Fulfilling the diagnostic criteria for SAD according to ICD-10 classification of mental and behavioral disorders (F 40.1).
排除标准
- •Previously diagnosed with autism spectrum disorders.
- •Previously diagnosed with psychotic disorders.
- •Severe depression (>29 Major Depression Inventory)
- •Dependence syndrome
- •Suicidal ideation.
- •Dementia/Intellectual disability.
- •Epilepsy.
- •Taking part in other kinds of psychological intervention for SAD.
- •Medication (SSRI, benzodiazepine, MAOI) type and doses needs to be stable three months prior to inclusions and during the intervention.
结局指标
主要结局
Social Anxiety Interaction Scale
时间窗: post-treatment (week 10)
The instrument is a measure of social anxiety symptoms and consists of 20 items assessing cognitive, affective, and behavioral responses to social interaction. The scale ranges from 0 to 80. Higher scores indicate worse outcome. Participants have to indicate to what degree they feel each statement is characteristic to them using a 5-point Likert scale (0 = not at all, 1 = slightly, 2 = moderately, 3 = very, 4 = extremely). The instrument has high internal consistency, Cronbach's alpha = 0.93, and high test-retest reliability, r = 0.92 (45).
次要结局
- EQ-5D-5L(post-treatment (week 10))
- Alcohol Use Disorders Identification Test(pre-treatment (week 1))
- Fear of Negative Evaluation - Brief version(post-treatment (week 10))
- Drug use disorders identification test(pre-treatment (week 1))
- Leibowitz Anxiety Scale - Self report version(post-treatment (week 10))
- Major Depression inventory(post-treatment (week 10))
研究者
Per T Ørskov
Postdoc
Region of Southern Denmark