Presence and Relapse Rates in Patients With Alcohol Use Disorder Using Virtual Reality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Craving
研究概览
简要总结
Investigation of the influence of the sense of presence during a Virtual Reality Cue-Exposure Therapy (VR-CET) with alcohol-associated cues on craving and relapse rates.
Study group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months.
Primary hypothesis: the experience of presence during a virtual presentation of alcohol in alcohol-dependent patients is associated with levels of craving for alcohol during VR-CET.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18-65 years
- •diagnosis of alcohol dependence according to ICD-10 (F10.2)
- •completed in-patient withdrawal treatment during the last 3 months
- •history of alcohol craving, confrmed via craving questionnaires
- •able to provide written informed consent
排除标准
- •substance dependence other than alcohol and nicotine
- •current alcohol intoxication (randomly tested via measurement of breath alcohol concentration)
- •unable to understand the study information, consent form or principles of the study
- •abstinence for less than 7 days or on-going consumption of alcohol
- •severe neuropsychiatric disorder, e.g., schizophrenia spectrum disorders, bipolar afective disorder or substantial cognitive impairment
- •somatic diseases for which VR is associated with risks, e.g. photosensitive epilepsy
- •acute suicidality or acute endangerment of others
- •concurrent pharmacological treatment targeting AUD (i.e. benzodiazepines) or craving (i.e. acamprosate, disulfram, naltrexone, nalmefene)
结局指标
主要结局
Craving
时间窗: VR-group: 6 appointments/6 weeks. Every appointment pre VR exposure / control group: 6 appointments/6 weeks, measures once every appointment, both groups: follow up appointments after 6 weeks + after 12 weeks
subjective craving for alcohol, measured with Obsessive Compulsive Drinking Scale (OCDS, scores 0-56; higher scores indicating higher craving levels)
次要结局
- Quality of Life(both groups: assessment during appointment 1 and 6 and during follow up appointments after 6 and 12 weeks)
- Motion Sickness(VR group: pre and post VR exposure (6 appointments/6 weeks))
- Presence in VR(VR group: post VR exposure (6 appointments/6 weeks))
- Relapse rates(both groups: follow up appointment after 6 weeks, follow up appointment after 12 weeks)
研究者
Alva Lütt
Dr. med.
Charite University, Berlin, Germany