Long-term Tablet-computer Based Casual Puzzle Video Game Intervention in Healthy Older and Cognitively Impaired Persons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Primary outcome measure - Attention: Visual Search
研究概览
简要总结
This study aims at investigating the effects of tablet-based puzzle video games on cognitive function and emotional well-being. This study extends preliminary findings of studies looking at short-term benefits of playing puzzle video games to a long-term intervention in healthy older adults and patients suffering from cognitive impairment due to mild cognitive impairment or acquired brain injury. To this end, the investigators compare two interventions: A tablet-based puzzle video games experimental intervention and a control intervention tablet newspaper-reading control intervention. This study uses a 16-week, assessor blinded, randomized crossover design with two phases of treatment and three waves of measurement. Participants are randomly allocated to either the experimental or control intervention for 8 weeks, then interventions are crossed over. Both groups receive both interventions in opposite order. At three time points (pre-, mid- and post-test) higher cognitive function and emotional well-being are tested using standardised neuropsychological tests and questionnaires.
详细描述
The focus of the current project is to examine the cognitive and emotional benefits of a casual puzzle video game (CPVG) intervention in healthy older adults (HOA), patients suffering from mild cognitive impairment (MCI) and acquired brain injury (ABI). Although there have only been a small number of studies specifically using CPVG interventions, recent studies were able to demonstrate the validity of CPVG in improving attentional and executive function and speed of processing (Oei & Patterson, 2013; Stroud & Whitbourne, 2015; Styron, 2015) in healthy older adults as well as their potential in reducing depressive symptoms, physical stress and anxiety (Russoniello, O'Brien, & Parks, 2009). These findings match general findings from video game training studies reporting improved processing speed, attentional, executive and visuospatial skills (Jak et al., 2013). In addition a recent large-scale study showed that regular engagement in Sudoku and similar puzzles represents a cognitively enriching leisure activity prevents and delays age-related cognitive decline (Ferreira, Owen, Mohan, Corbett, & Ballard, 2015). Since depressive disorders affect between 10% and 20% older adults and even more in persons suffering from MCI and dementia, and that mood disorders affect about 31% (anxiety disorders up to 40%) patients after suffering a stroke, these populations could potentially draw both cognitive and emotional benefits from CPVG intervention (Arba et al., 2016; Barua, Ghosh, Kar, & Basilio, 2011; Robinson, 2003).
The main objective of this study is to investigate long-term training benefits of a CPVG intervention on cognitive and emotional functioning in healthy older adults and patients with cognitive impairment.
The primary objective of this study is to examine whether a long-term CPVG intervention significantly improves attentional function (visual search) and leads to in-game learning effects in healthy older participants and cognitively impaired patients (MCI, ABI). The secondary objectives include: a) improvements on further cognitive outcome measures proposed to be engaged by the CPVG (attention, processing speed, working memory and spatial reasoning) and b) the efficacy of the CPVG intervention in reducing symptoms of depression, anxiety and stress and improving quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study will include outcome assessor blinding as recommended in a publication on methodological quality criteria for cognitive rehabilitation research and computer game training in older adults (Bleakley et al., 2015; Cicerone, Azulay, & Trott, 2009).
This will ensure that the person conducting the assessment of outcome measures will be unaware of the participant's treatment condition. For this purpose, a central randomization procedure will be used where a designated staff member not involved in the study will conduct and securely maintain the randomization, contact and allocate participants and use central methods (e.g. phone or secure computer) after the patient is enrolled. This way the treatment assignments are not revealed to the assessors when conducting the outcome assessments. The assessors will also be excluded from any activity pertaining to the intervention activities (e.g. instructing participants, distributing the tablet-computers).
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal or corrected-to-normal visual acuity
- •Informed consent as documented by signature
- •Healthy older adults:
- •Aged 65 years and older
- •Absence of cognitive impairment as assessed with a Montreal Cognitive Assessment (MoCA) of above
- •Mild cognitive impairment:
- •Aged 65 years and older
- •Objective cognitive impairment as assessed with a Montreal Cognitive Assessment (MoCA) smaller than 26 (MoCA < 26).
- •Acquired brain injury:
- •Diagnosis of acquired brain damage and cognitive impairment (e.g. attentional and executive deficits) as diagnosed through neuropsychological assessment combined with a MoCA score of 26 and smaller
排除标准
- •Insufficient coordinative, motor and perceptual ability to handle a tablet- computer.
- •Healthy older adults: History of neurological or psychiatric deficits
- •Acquired brain injury: History of any other psychiatric deficits
- •Mild cognitive impairment: History of any other neurological or psychiatric deficits
研究组 & 干预措施
Puzzle Video Game Intervention
Group T will first receive the experimental and then the control intervention (T-C) In phase I both groups take a baseline measurement (pre-test), then group T is given the casual puzzle game task (experimental intervention). After phase I (8 weeks) both groups are post-tested (mid-test). In phase II, groups are switched and the the experimental intervention group T now serves as control. After phase II (16 weeks) both groups are post-tested again.
干预措施: Experimental - Puzzle Video Game Intervention (Behavioral)
Puzzle Video Game Intervention
Group T will first receive the experimental and then the control intervention (T-C) In phase I both groups take a baseline measurement (pre-test), then group T is given the casual puzzle game task (experimental intervention). After phase I (8 weeks) both groups are post-tested (mid-test). In phase II, groups are switched and the the experimental intervention group T now serves as control. After phase II (16 weeks) both groups are post-tested again.
干预措施: Control - Tablet Newspaper Reading Intervention (Behavioral)
Tablet Newspaper Reading Intervention
Group C will first receive the the control intervention and then experimental and (C-T). In phase I both groups take a baseline measurement (pre-test), then group C is performing the newspaper reading task (control intervention). After phase I (8 weeks) both groups are post-tested (mid-test). In phase II, groups are switched and the control group C is given the experimental intervention (casual puzzle game task). After phase II (16 weeks) both groups are post-tested again.
干预措施: Experimental - Puzzle Video Game Intervention (Behavioral)
Tablet Newspaper Reading Intervention
Group C will first receive the the control intervention and then experimental and (C-T). In phase I both groups take a baseline measurement (pre-test), then group C is performing the newspaper reading task (control intervention). After phase I (8 weeks) both groups are post-tested (mid-test). In phase II, groups are switched and the control group C is given the experimental intervention (casual puzzle game task). After phase II (16 weeks) both groups are post-tested again.
干预措施: Control - Tablet Newspaper Reading Intervention (Behavioral)
结局指标
主要结局
Primary outcome measure - Attention: Visual Search
时间窗: Post-test (Change from Baseline at week 8)
Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery
Primary outcome measure - Attention: Visual Search
时间窗: Pre-test (Baseline, week 0)
Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery
Primary outcome measure - Attention: Visual Search
时间窗: Mid-test (Change from Baseline at week 4)
Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery
次要结局
- Additional attentional outcomes(Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8))
- Spatial reasoning(Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8))
- Emotion and well-being 3(Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8))
- Self-efficacy(Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8))
- Working memory(Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8))
- Emotion and well-being 1(Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8))
- Emotion and well-being 2(Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8))
- Processing speed(Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8))
- Intervention compliance(Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8))
- Game experience(Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8))