Use of Personalized Virtual Reality and Paper-and-pencil Interventions as Complementary Tools in the Treatment of Alcohol Use Disorder: From Cognitive Rehabilitation to the Prevention of Relapses.
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
- Montreal Cognitive Assessment (Cognitive Screening).
研究概览
简要总结
Cognitive dysfunction is one of the different consequences of excessive alcohol consumption, affecting many domains associated with prefrontal and temporal lobes, such as attention, verbal fluency, and memory.
This study will explore the clinical impact of two cognitive rehabilitation tools to promote cognitive improvements of AUD individuals.
详细描述
Excessive consumption of alcohol affects many functions associated with the prefrontal and temporal lobes, including different executive functions, memory, and complex motor control. Among several treatments, the Transtheoretical Model, a multidisciplinary approach, is one of the most standardized. However, it lacks effective and innovative cognitive rehabilitation tools. In this study, two cognitive rehabilitation tools, already clinically validated for stroke patients, will be implemented to promote cognitive recovery of Alcohol Use Disorder (AUD) individuals under treatment in the Alcoholic Rehabilitation Center S. Ricardo Pampuri from Casa de Saúde S. João de Deus (Madeira, Portugal). Within a randomized controlled trial with 60 participants, this study intend to assess and compare the clinical effectiveness of both a paper-and-pencil tasks training and content equivalent virtual reality (VR) simulation of activities of daily living with time-matched standard 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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients of Centro de Alcoologia Ricardo Pampuri (with Alcohol use Disorder diagnosis)
- •Education (able to read and write)
- •Standard neuropharmacological protocol
排除标准
- •Abuse of other substances
- •Neurological and psychiatric pathology (present or past)
- •Severe depressive symptoms as assessed by the Beck Depression Inventory
- •Visual problems that can affect the performance of the tasks (hemianopsy, diplopia)
研究组 & 干预措施
Virtual Reality
Standard treatment protocol and 12 sessions (30 minutes each) of personalized cognitive activities in a virtual city environment (Reh@City).
干预措施: Virtual Reality (Procedure)
Paper and Pencil
Standard treatment protocol and 12 sessions (30 minutes each) of personalized paper-and-pencil cognitive activities,using the Task Generator tool.
干预措施: Paper and Pencil (Procedure)
Control Group
The standard treatment protocol.
干预措施: Control Group (Procedure)
结局指标
主要结局
Montreal Cognitive Assessment (Cognitive Screening).
时间窗: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Change from baseline in the Montreal Cognitive Assessment
Frontal Assessment Battery (FAB- Executive functioning).
时间窗: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Change from baseline in the Frontal Assessment Battery.
SF-36 Medical Outcomes Study 36 - Item Short - Form Health Survey
时间窗: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Change from baseline in the SF-36
次要结局
- Toulouse-Pieron (Attention).(Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up)
- Verbal Paired Associates (WMS-III) (Memory).(Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up)
- Letter-number sequencing (WAIS-III)- Working Memory(Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up])
- Rey Complex Figure (Visuospatial skills and visual memory).(Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up)
- Symbol Search and Coding (WAIS III).(Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up])
研究者
Sergi Bermúdez i Badia
Associate Professor at the University of Madeira and Senior Researcher at NOVA-LINCS
Universidade da Madeira