Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence: A Randomized Controlled Trial (CRAVR)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Reduction in total alcohol consumption
研究概览
简要总结
The study is a single-blinded, randomized, controlled, 12 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) in patients with a diagnosis of alcohol dependence.
详细描述
Recruitment of participants:
102 patients will be recruited from the Novaví outpatient clinics, where they will be informed orally and in writing about the research project and, if they are interested, an information meeting is booked. If patients show symptoms of abstinence, these are treated prior to the information meeting by doctors and nurses in Novaví. If the patient then wishes to participate and meets the inclusion criteria, informed consent is obtained and screening is performed using the questionnaires described later. Included patients will then be randomized to either:
- Virtual reality-assisted cognitive behavioral therapy (VR-CBT)
- Cognitive behavioral therapy (CBT) without VR (control group)
Screening:
At the screening sessions, patients' medical history is obtained, as well as their alcohol intake over the past 30 days recorded via Timeline Follow-Back (TLFB). Patients are also asked about previous alcohol dependence treatment and general information about psychosocial factors incl. education, work, marital status, and functional level using Global Assessment of functioning (GAF). In addition, alcohol-related problems are assessed using the Alcohol Users Identification Test (AUDIT), abstinence using the Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar), intake of other drugs using the Drug User Identification Test (DUDIT), and alcohol craving using the Penn Alcohol Craving Scale (PACS). The Becks questionnaires, Depression Inventory 2 (BDI-II) and Beck's Anxiety Inventory (BAI), are included to assess the degree of anxiety and depression, and in addition, tests of mental function are performed using the Screening for Cognitive Impairment in Psychiatry (SCIP).
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: Baseline, 6 months, 9 months, 12 months
Percent change 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
- Change in Penn Alcohol Craving Scale (PACS) score(Baseline, 6 months, 9 months, 12 months)
- Change in Drug User Identification Test (DUDIT) score(Baseline, 6 months, 9 months, 12 months)
- Change in heavy drinking days(Baseline, 6 months, 9 months, 12 months)
- Alcohol withdrawal symptoms(Evaluated at inclusion)
- Change in Alcohol Users Identification Test (AUDIT) score(Baseline, 6 months, 9 months, 12 months)
- Screening for Cognitive Impairment in Psychiatry (SCIP) score(Baseline, 6 months, 9 months, 12 months)
- Change in Global Assessment of functioning (GAF) score(Baseline, 6 months, 9 months, 12 months)
- Becks Anxiety Inventory (BAI) score(Baseline, 6 months, 9 months, 12 months)
- Qualitative assessment(After completion of a full treatment period of 6 months)
- Becks Depression Inventory 2 (BDI-II) score(Baseline, 6 months, 9 months, 12 months)
- Simulator Sickness Questionnaire (SSQ)(Each of the 14 treatment sessions over 6 months)
- VR-induced craving on a visual analog scale (VAS)(Each of the 14 treatment sessions over 6 months)
研究者
Anders Fink-Jensen, MD, DMSci
Professor, MD, DMSci
Psychiatric Centre Rigshospitalet