A Randomized Controlled Study of Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the level of anxiety
研究概览
简要总结
To explore the efficacy of drugs combined with virtual reality exposure therapy in the treatment of phobias compared with single drug treatment.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for phobias in DSM-IV.
- •Age from 18 to 45 years old.
- •Graduated from junior high school or above.
- •No serious physical disease, no serious visual impairment, and no family history of mental illness.
排除标准
- •Exclude other psychiatric diagnosis and treatment history.
研究组 & 干预措施
drug only
Sertraline was given as a single drug, with an initial dose of 50 mg/d, and gradually increased to the maximum dose of 200 mg/d after 2 weeks. The treating physician will determine the specific dose adjustment according to the patient's condition.
干预措施: Sertraline (Drug)
vert combine with drug
On the basis of sertraline drug treatment, phobia patients were given 2d/times from the 5th week, each 35-45min VR exposure treatment, 15 times as a course of treatment.
干预措施: vert (Device)
vert combine with drug
On the basis of sertraline drug treatment, phobia patients were given 2d/times from the 5th week, each 35-45min VR exposure treatment, 15 times as a course of treatment.
干预措施: Sertraline (Drug)
结局指标
主要结局
the level of anxiety
时间窗: 3 months
the score of Hamilton anxiety scale, the minimum and maximum values are 0 and 56, and higher scores mean a worse outcome.
heart rate of the patients
时间窗: 3 months
take the heart rate as a biomarker of fear, the faster heart rate means the participate is more afraid
次要结局
未报告次要终点