Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence: A Pilot Study (CRAVR-Pilot)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Reduction in total alcohol consumption
研究概览
简要总结
The pilot study is a single-blinded, randomized, controlled, 2 months clinical trial. The objective is to investigate the feasibility, effects and side-effects of virtual reality-assisted cognitive behavioral therapy (VR-CBT) vs. cognitive behavioral therapy (CBT) on alcohol intake in patients with a diagnosis of alcohol dependence.
详细描述
Pilot study rational:
Prior to the major randomized clinical trial, a total of 10 participants with alcohol dependence are included in a pilot trial. This is done to examine the feasibility of the following elements:
i) adherence to the intervention and drop-outs ii) the therapists' theoretical and practical abilities to use the virtual reality (VR) equipment iii) the time spent on virtual reality during the therapy session iv) the need for technical support v) the collaboration in the project group and vi) the participants' experience of virtual reality-assisted cognitive behavioral therapy (VRCBT).
During the pilot trial, patients receive standardized alcohol treatment for alcohol dependence at the Novavis outpatient clinics based on national guidelines from health authorities. Three of the therapy sessions contain VR-CBT.
Recruitment of participants:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed oral and written consent
- •Meets criteria for alcohol dependence syndrome according to International Classification of Diseases (ICD) 10, WHO & Diagnostic and Statistical Manual of Mental Disorder (DSM-5)
- •Age 18 - 70 years old (both included)
- •Minimum 5 'heavy drinking days' in the last month, which is defined as an alcohol intake above 60/48 grams or 5/4 items per. day for resp. men and women over the past 30 days
排除标准
- •Other active substance use defined by DUDIT score> 6 (for men)> 2 (for women) and meet the criteria for other drug dependence according to ICD-10 (excluding nicotine)
- •Does not speak or understand Danish
- •Mental retardation or known severe psychiatric illness or other condition where it is assessed that will interfere with participation eg severely impaired vision or hearing.
- •Medical alcohol treatment (disulfiram, acamprosate, naltrexone or nalmefen) within the latest 4 weeks and during the treatment period
结局指标
主要结局
Reduction in total alcohol consumption
时间窗: From baseline to 1 week and 1 month after the third and final treatment session
Percent reduction in alcohol consumption, defined as "x" grams of alcohol for past 30 days. This will be registered using the Timeline-Follow-Back (TLFB) method.
次要结局
- Reduction in Alcohol Users Identification Test (AUDIT) score(Baseline, 1 week and 1 month follow-up)
- Screening for Cognitive Impairment in Psychiatry (SCIP) score(Baseline, 1 week and 1 month follow-up)
- Reduction in Global Assessment of functioning (GAF) score(Baseline, 1 week and 1 month follow-up)
- Simulator Sickness Questionnaire (SSQ)(Evaluated in each session)
- Reduction in Drug User Identification Test (DUDIT) score(Baseline, 1 week and 1 month follow-up)
- Becks Depression Inventory 2 (BDI-II) score(For baseline to 1 week and 1 month follow-up)
- VR-induced craving on a visual analog scale (VAS)(Evaluated in each session)
- VR-induced thoughts, emotions, physiological reactions and behavior(Evaluated in each session)
- Reduction in heavy drinking days(Baseline,1 week and 1 month follow-up)
- Reduction in Penn Alcohol Craving Scale (PACS) score(Baseline, 1 week and 1 month follow-up)
- Becks Anxiety Inventory (BAI) score(For baseline to 1 week and 1 month follow-up)
研究者
Anders Fink-Jensen, MD, DMSci
Professor, MD, DMSci
Psychiatric Centre Rigshospitalet