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

NCT03139799 | Completed DMC

• 1 other identifier: 2016-01281
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Acquired Brain Injury; Cognitive Impairment; Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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)

• Processing 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

  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 1

  Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)

Study Arms (2)

Puzzle Video Game Intervention

EXPERIMENTAL

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; Behavioral: Control - Tablet Newspaper Reading Intervention

Tablet Newspaper Reading Intervention

ACTIVE COMPARATOR

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; Behavioral: Control - Tablet Newspaper Reading Intervention

Interventions

Experimental - Puzzle Video Game Intervention BEHAVIORAL

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).

Puzzle Video Game Intervention; Tablet Newspaper Reading Intervention

Control - Tablet Newspaper Reading Intervention BEHAVIORAL

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.

Puzzle Video Game Intervention; Tablet Newspaper Reading Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

ARTORG Center for Biomedical Engineering Research

Bern, 3008, Switzerland

Location

Related Publications (9)

• 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.

  PMID: 23516504 BACKGROUND

• 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.

  PMID: 26448498 BACKGROUND

• 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.

  PMID: 19592761 BACKGROUND

• 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.

  PMID: 23423553 BACKGROUND

• 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.

  PMID: 24989949 BACKGROUND

• 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.

  PMID: 26778600 BACKGROUND

• 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.

  PMID: 22048509 BACKGROUND

• 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.

  PMID: 24652863 BACKGROUND

• 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.

  PMID: 19892075 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Brain Injuries

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Prabitha Urwyler, PD. Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 4, 2017
• Study Start: July 15, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)