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

November 9, 2022 updated by: University of Bern
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3008
        • ARTORG Center for Biomedical Engineering Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Behavioral: Experimental - Puzzle Video Game Intervention
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).
Behavioral: Control - Tablet Newspaper Reading Intervention
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.
ACTIVE_COMPARATOR: 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.
Behavioral: Experimental - Puzzle Video Game Intervention
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).
Behavioral: Control - Tablet Newspaper Reading Intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary outcome measure - Attention: Visual Search
Time Frame: Pre-test (Baseline, week 0)
Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery
Pre-test (Baseline, week 0)
Primary outcome measure - Attention: Visual Search
Time Frame: Mid-test (Change from Baseline at week 4)
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
Time Frame: Post-test (Change from Baseline at week 8)
Visual Scanning subtest from the computerized Test of Attentional Performance (TAP) test battery
Post-test (Change from Baseline at week 8)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Additional attentional outcomes
Time Frame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
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
Time Frame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
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
Time Frame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
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
Time Frame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
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
Time Frame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
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
Time Frame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
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
Time Frame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
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
Time Frame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
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
Time Frame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
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
Time Frame: Pre-test (Baseline, week 0), Mid-test (Change from Baseline at week 4) and Post-test (Change from Baseline at week 8)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Prabitha Urwyler, PD. Dr., University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-01281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Experimental - Puzzle Video Game Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings