Virtual Reality Cognitive Training in Individuals With Alcohol Use Disorder Undergoing Residential Treatment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Global cognition
研究概览
简要总结
This study aims to test the feasibility of using exercises in virtual reality for cognitive training of patients with alcohol use disorder undergoing residential treatment.
详细描述
Alcohol use disorder has been associated with diverse physical and mental morbidities. Among the main consequences of chronic and excessive alcohol use are cognitive and executive deficits. Some of these deficits may be reversed, with improvements in specific cognitive and executive domains, with behavioral approaches consisting in cognitive training. The advent of computer-based interventions may leverage these improvements, but RCTs on the use of digital interactive-based intervention are still scarce.
The aim consists in exploring whether a cognitive training approach using virtual reality exercises based on activities of daily living is feasible for improving cognitive function in patients with alcohol use disorder undergoing residential treatment.
The method consists in a two-arm randomized controlled trial with individuals recovering from alcohol use disorder in a therapeutic community that will be assigned to an experimental and a control group. The experimental group consists of virtual reality-based cognitive training whereas the control group of treatment-as-usual. A comprehensive neuropsychological battery of tests will be used consisting in tests for global cognition, executive functions, and specific tests form memory, attention and cognitive flexibility. The AB design will involve a baseline assessment before intervention and post-intervention assessment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Without history of psychiatric or neurological disorders
- •Attending the inpatient program for rehabilitation of alcohol use disorder
排除标准
- •Psychosis episode during the intervention
- •Withdrawal from the inpatient program for rehabilitation of alcohol use disorder
结局指标
主要结局
Global cognition
时间窗: 5 weeks
Global cognition is assessed using the Montreal Cognitive Assessment that is a cognitive screening test that consists of 11 items assessing cognitive domains such as visuospatial orientation, naming, memory, attention, language, abstraction, evocation and orientation. This study focuses on the total score that is calculated from the sum of scores to each dimension of the test, in which higher scores reflect better test performance.
Executive functions
时间窗: 5 weeks
Executive functions are a set of higher order cognitive functions that control goal directed behavior. Executive functions in this study are assessed using the Frontal Assessment Battery that evaluates six constructs: conceptualization, mental flexibility, programming, sensitivity to interference, inhibitory control, and environmental autonomy. This study focuses on the total score that is calculated from sum of scores to each of the six dimensions of the test, in which higher scores describe better test performance.
Cognitive flexibility
时间窗: 5 weeks
Cognitive flexibility describes the ability to switch between different tasks. Cognitive flexibility in this study is assessed using the Wisconsin Card Sorting Test that evaluates strategic planning, abstract thinking, and capacity for perseveration and the ability to use environmental feedback. This test in this study is scored on six performance parameters: Number of trials administered; number of total errors; number of perseverative errors; number of trials to complete first category; failure to maintain set; and number of conceptual level responses. Higher scores in these dimensions reflect poorer test performance, except for the number of conceptual level responses.
次要结局
未报告次要终点