Long-term Tablet-computer Based Casual Puzzle Video Game Intervention in Healthy Older and Cognitively Impaired Persons

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long-term Tablet-computer Based Casual Puzzle Video Game Intervention in Healthy Older and Cognitively Impaired Persons

Conditions
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Mild Cognitive Impairment, Acquired Brain Injury, Cognitive Impairment, Healthy

Intervention / Treatment
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* Behavioral: Experimental - Puzzle Video Game Intervention
* Behavioral: Control - Tablet Newspaper Reading Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 26. 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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 (group T) or control intervention (group C). Group T will first receive the experimental and then the control intervention (T-C) while group C is given the opposite order of intervention (C-T). In phase I both groups take a baseline measurement (pre-test), then group T is given the casual puzzle game task (experimental intervention) while 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) while the experimental intervention group T now serves as control. After phase II (16 weeks) both groups are post-tested again.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Puzzle Video Game Intervention<br>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. | Behavioral: Experimental - Puzzle Video Game Intervention<br>* The psychological intervention consists of two custom-made versions of popular commercial casual puzzle video games (Flow Free, Big Duck Games LCC; Bejeweled, PopCap Games). The puzzle games are delivered on tablet-computers computer (12.9-inch tablet computer iPad Pro, Apple Inc., Cupertino, CA, USA).<br>Behavioral: Control - Tablet Newspaper Reading Intervention<br>* The control intervention uses a newspaper/ magazine reading task that will be delivered to participants using the same device (iPad Pro) as in the experimental intervention. The newspaper/ magazine reading task will be running on the built-in Apple Newsstand application. Participants will be offered subscriptions for two newspapers and/or magazines that they are instructed to read following the same regime as in the experimental condition.<br>|
| Active Comparator: Tablet Newspaper Reading Intervention<br>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. | Behavioral: Experimental - Puzzle Video Game Intervention<br>* The psychological intervention consists of two custom-made versions of popular commercial casual puzzle video games (Flow Free, Big Duck Games LCC; Bejeweled, PopCap Games). The puzzle games are delivered on tablet-computers computer (12.9-inch tablet computer iPad Pro, Apple Inc., Cupertino, CA, USA).<br>Behavioral: Control - Tablet Newspaper Reading Intervention<br>* The control intervention uses a newspaper/ magazine reading task that will be delivered to participants using the same device (iPad Pro) as in the experimental intervention. The newspaper/ magazine reading task will be running on the built-in Apple Newsstand application. Participants will be offered subscriptions for two newspapers and/or magazines that they are instructed to read following the same regime as in the experimental condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measure - Attention: Visual Search | Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery | Pre-test (Baseline, week 0) | 
| Primary outcome measure - Attention: Visual Search | Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery | Mid-test (Change from Baseline at week 4) | 
| Primary outcome measure - Attention: Visual Search | Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery | Post-test (Change from Baseline at week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional attentional outcomes | Trail Making Test (TMT) Part A for selective attention and Part B for divided attention | Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8) | 
| Processing speed | Pattern Comparison Test (PCT) for spatial perception speed as well as TMT-A and -B for visual search speed. | Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8) | 
| Working memory | Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) subtests Digit Span (forward, backward and complex) for verbal working memory, Spatial Span (forward and backward) for visuospatial working memory and Spatial Addition for complex visuospatial memory based on the n-back paradigm. | Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8) | 
| Spatial reasoning | Maze Task from the Neuropsychological Assessment Battery (NAB) for planning, organization, reasoning and problem solving. | 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 | Profile of Mood States (POMS) that measures six mood subscales | 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 | State Trait Anxiety Inventory (STAI) that measures anxiety as an emotional state and personality trait | 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 | World Health Organization's WHOQOL-BREF quality of life assessment | Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8) | 
| Self-efficacy | Assessed with the General Self-Efficacy Scale | Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8) | 
| Intervention compliance | The data saved each time the participants engage in a session of the casual puzzle game intervention will serve as a measure of gameplay frequency and 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 | Measured with the Perception of Training Questionnaire | Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8) |