A Comparative Controlled Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The response criterion is a decrease of 50% of the agoraphobia subscore on the Fear Questionnaire
研究概览
简要总结
The study aims at comparing virtual reality therapy (VRT) with a usual cognitive behavior therapy (CBT) program for agoraphobia. A waiting list represents the control condition. The investigators' purpose is to test a pure VRT compared with a pure CBT, as previous works suggest that the combination of the two methods are clinically effective. Patients receive a two-page information leaflet about the trial and sign an informed consent. After the first evaluation, they are randomized, in three centers (Lyon, Paris, Luxemburg), either to VRT (12 sessions) or CBT (12 sessions), or a waiting-list control condition for three months. After three months the waiting list is randomized to VRT or CBT. The follow-up is one year from entry into the active part of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Ect
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study includes 90 patients, aged from 18 to 60, with DSM-4 panic disorder with agoraphobia.
- •Patients should not be clinically depressed and present a Hamilton Scale of Depression score of less than 18.
排除标准
- •Patients with active medication (antidepressants, neuroleptics, mood stabilizers, benzodiazepines, Kava Kava, or hypericum) or street drugs. Minor herbal medicine is tolerated.
结局指标
主要结局
The response criterion is a decrease of 50% of the agoraphobia subscore on the Fear Questionnaire
次要结局
- Pre-test, post-test, 6 months and one year
- Panic Disorder Severity Scale
- Agoraphobic cognitions
- Panic, phobia, generalized anxiety
- Trait State Anxiety Inventory (STAI)
- Hamilton Anxiety Scale
- Dissociative experiences
- Beck Depression Inventory
- Quality of Life, handicap
- Spatial cognition: Rey's Figure and Rod and Frame test
- Therapeutic expectations (pre-test)
- Therapeutic relationship (post-test)