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

Primary Purpose

Mild Cognitive Impairment, Acquired Brain Injury, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Experimental - Puzzle Video Game Intervention
Control - Tablet Newspaper Reading Intervention
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ARTORG Center for Biomedical Engineering Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Puzzle Video Game Intervention

Tablet Newspaper Reading Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Primary outcome measure - Attention: Visual Search
Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery
Primary outcome measure - Attention: Visual Search
Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery
Primary outcome measure - Attention: Visual Search
Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery

Secondary Outcome Measures

Additional attentional outcomes
Trail Making Test (TMT) Part A for selective attention and Part B for divided attention
Processing speed
Pattern Comparison Test (PCT) for spatial perception speed as well as TMT-A and -B for visual search speed.
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.
Spatial reasoning
Maze Task from the Neuropsychological Assessment Battery (NAB) for planning, organization, reasoning and problem solving.
Emotion and well-being 1
Profile of Mood States (POMS) that measures six mood subscales
Emotion and well-being 2
State Trait Anxiety Inventory (STAI) that measures anxiety as an emotional state and personality trait
Emotion and well-being 3
World Health Organization's WHOQOL-BREF quality of life assessment
Self-efficacy
Assessed with the General Self-Efficacy Scale
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.
Game experience
Measured with the Perception of Training Questionnaire

Full Information

First Posted
April 26, 2017
Last Updated
November 9, 2022
Sponsor
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03139799
Brief Title
Long-term Tablet-computer Based Casual Puzzle Video Game Intervention in Healthy Older and Cognitively Impaired Persons
Official Title
Long-term Tablet-computer Based Casual Puzzle Video Game Intervention in Healthy Older and Cognitively Impaired Persons
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Acquired Brain Injury, Cognitive Impairment, Healthy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Puzzle Video Game Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Tablet Newspaper Reading Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Experimental - Puzzle Video Game Intervention
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Control - Tablet Newspaper Reading Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary outcome measure - Attention: Visual Search
Description
Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery
Time Frame
Pre-test (Baseline, week 0)
Title
Primary outcome measure - Attention: Visual Search
Description
Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery
Time Frame
Mid-test (Change from Baseline at week 4)
Title
Primary outcome measure - Attention: Visual Search
Description
Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery
Time Frame
Post-test (Change from Baseline at week 8)
Secondary Outcome Measure Information:
Title
Additional attentional outcomes
Description
Trail Making Test (TMT) Part A for selective attention and Part B for divided attention
Time Frame
Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
Title
Processing speed
Description
Pattern Comparison Test (PCT) for spatial perception speed as well as TMT-A and -B for visual search speed.
Time Frame
Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
Title
Working memory
Description
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.
Time Frame
Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
Title
Spatial reasoning
Description
Maze Task from the Neuropsychological Assessment Battery (NAB) for planning, organization, reasoning and problem solving.
Time Frame
Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
Title
Emotion and well-being 1
Description
Profile of Mood States (POMS) that measures six mood subscales
Time Frame
Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
Title
Emotion and well-being 2
Description
State Trait Anxiety Inventory (STAI) that measures anxiety as an emotional state and personality trait
Time Frame
Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
Title
Emotion and well-being 3
Description
World Health Organization's WHOQOL-BREF quality of life assessment
Time Frame
Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
Title
Self-efficacy
Description
Assessed with the General Self-Efficacy Scale
Time Frame
Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
Title
Intervention compliance
Description
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.
Time Frame
Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
Title
Game experience
Description
Measured with the Perception of Training Questionnaire
Time Frame
Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prabitha Urwyler, PD. Dr.
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
ARTORG Center for Biomedical Engineering Research
City
Bern
ZIP/Postal Code
3008
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23516504
Citation
Oei AC, Patterson MD. Enhancing cognition with video games: a multiple game training study. PLoS One. 2013;8(3):e58546. doi: 10.1371/journal.pone.0058546. Epub 2013 Mar 13.
Results Reference
background
PubMed Identifier
26448498
Citation
Stroud MJ, Whitbourne SK. Casual Video Games as Training Tools for Attentional Processes in Everyday Life. Cyberpsychol Behav Soc Netw. 2015 Nov;18(11):654-60. doi: 10.1089/cyber.2015.0316. Epub 2015 Oct 8.
Results Reference
background
PubMed Identifier
19592761
Citation
Russoniello CV, O'Brien K, Parks JM. EEG, HRV and Psychological Correlates while Playing Bejeweled II: A Randomized Controlled Study. Stud Health Technol Inform. 2009;144:189-92.
Results Reference
background
PubMed Identifier
23423553
Citation
Jak AJ, Seelye AM, Jurick SM. Crosswords to computers: a critical review of popular approaches to cognitive enhancement. Neuropsychol Rev. 2013 Mar;23(1):13-26. doi: 10.1007/s11065-013-9226-5. Epub 2013 Feb 20.
Results Reference
background
PubMed Identifier
24989949
Citation
Ferreira N, Owen A, Mohan A, Corbett A, Ballard C. Associations between cognitively stimulating leisure activities, cognitive function and age-related cognitive decline. Int J Geriatr Psychiatry. 2015 Apr;30(4):422-30. doi: 10.1002/gps.4155. Epub 2014 Jul 3.
Results Reference
background
PubMed Identifier
26778600
Citation
Arba F, Ali M, Quinn TJ, Hankey GJ, Lees KR, Inzitari D; VISTA Collaboration. Lacunar Infarcts, Depression, and Anxiety Symptoms One Year after Stroke. J Stroke Cerebrovasc Dis. 2016 Apr;25(4):831-4. doi: 10.1016/j.jstrokecerebrovasdis.2015.12.018. Epub 2016 Jan 14.
Results Reference
background
PubMed Identifier
22048509
Citation
Barua A, Ghosh MK, Kar N, Basilio MA. Prevalence of depressive disorders in the elderly. Ann Saudi Med. 2011 Nov-Dec;31(6):620-4. doi: 10.4103/0256-4947.87100.
Results Reference
background
PubMed Identifier
24652863
Citation
Bleakley CM, Charles D, Porter-Armstrong A, McNeill MD, McDonough SM, McCormack B. Gaming for health: a systematic review of the physical and cognitive effects of interactive computer games in older adults. J Appl Gerontol. 2015 Apr;34(3):NP166-89. doi: 10.1177/0733464812470747. Epub 2013 Jan 17.
Results Reference
background
PubMed Identifier
19892075
Citation
Cicerone KD, Azulay J, Trott C. Methodological quality of research on cognitive rehabilitation after traumatic brain injury. Arch Phys Med Rehabil. 2009 Nov;90(11 Suppl):S52-9. doi: 10.1016/j.apmr.2009.05.019.
Results Reference
background

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

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