NCT05396586

Brief Summary

The present study investigates how individual differences in cognitive processing contribute to the efficacy of working memory training programs in an older adult population. In a randomized crossover design, different types of working memory training interventions will be evaluated within the same participants. Adding game-like elements to working memory training programs can increase motivation and engagement, which can increase learning. However this process, termed gamification, adds sensory complexity that can lead to increased mental load and/or distraction in older adults. Investigators hypothesize that gamification of training tasks will be beneficial to some and counterproductive to other participants. The investigators will test two models; the first assumes that participants with difficulty inhibiting distracting information will show better learning and transfer when assigned to non-gamified training, whereas those with more distractor tolerance will show better learning and transfer when assigned to gamified training. The second model states that the outcomes of the intervention will be better predicted by performance on measures of general cognitive ability. In a separate study, the investigators will compare working memory training that contains rich, multisensory information with a training program that contains only visual information. Here they will also test two models; the first assumes that participants with difficulty binding two stimulus streams will show better learning and transfer when assigned to visual-only working memory training, whereas participants who do not have this difficulty will show better learning and transfer when assigned to multisensory working memory training. The second model states that the outcomes of the intervention will be better predicted by performance on measures of general cognitive ability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2025

Completed
Last Updated

March 12, 2025

Status Verified

January 1, 2025

Enrollment Period

3 years

First QC Date

April 21, 2022

Last Update Submit

March 7, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in N-level

    N-back is a tablet-based updating working memory task. Participants see a consecutive stream of pictures and are asked to tap the pictures that match those presented N items earlier. All participants will complete 1-back and 2-back, progression to 3-back and beyond is based on performance on the previous level (no more than 4 errors). The outcome measure is the change in the highest N-level reached on the task compared to baseline at Day 2.

    Day 24, Day 46, Day 78

  • Change in Corsi span

    Corsi is a tabled-based measure of spatial working memory. Participants see characters emerge one at a time from twelve possible locations and are asked to repeat the sequence by tapping on the locations in the correct order. The task starts with set size two and increases in difficulty using an adaptive algorithm. Participants first play Simple Corsi (without a distractor task), followed by Complex Corsi (with a distractor task). The outcome measure is change in overall span, calculated as the sum of the two highest set sizes that can be recalled in Simple and Complex Corsi tasks, at the point of measurement compared to baseline at Day 3.

    Day 25, Day 47, Day 79

  • Change in Inhibitory Control Composite Score

    The score is the mean of standardized dependent variables on tablet-based inhibitory control tasks. The outcome measure is the change in the composite score at the point of measurement compared to baseline at Day 2.

    Day 24, Day 46, Day 78

  • Change in Everyday Memory Questionnaire Revised

    The Everyday Memory Questionnaire Revised (Royle \& Lincoln, 2008) consists of 13 items that describe everyday events that might involve forgetting. Participants are asked how often on average they think each one has happened to them over the past month on a 5-point scale (0-4) and the total score is calculated as the sum of all responses. The minimum total score is 0 and the maximum is 52, with higher scores indicative of greater presence of memory difficulties. The outcome measure is the change in total score at the point of measurement compared to baseline at Day 1.

    Day 24, Day 46, Day 77

Secondary Outcomes (9)

  • Training Experience Enjoyment Subscale I

    Day 24

  • Training Experience Enjoyment Subscale II

    Day 46

  • Training Experience Difficulty Subscale I

    Day 24

  • Training Experience Difficulty Subscale II

    Day 46

  • Training Experience Subjective Progress Subscale I

    Day 24

  • +4 more secondary outcomes

Other Outcomes (1)

  • Change in General Cognitive Ability Composite Score

    Day 77

Study Arms (2)

Condition 1

ACTIVE COMPARATOR

Training type 1 will be administered in the first part of the crossover trial and Training type 2 will be administered in the second part of the trial. Each training part consists of 20 twenty-minute long sessions with the recommended frequency of 2 sessions per work day. Thus each training part can be completed in 10 work days (2 weeks).

Behavioral: N-backBehavioral: SpanBehavioral: Multisensory

Condition 2

ACTIVE COMPARATOR

Training type 2 will be administered in the first part of the crossover trial and Training type 1 will be administered in the second part of the trial. Each training part consists of 20 twenty-minute long sessions with the recommended frequency of 2 sessions per work day. Thus each training part can be completed in 10 work days (2 weeks).

Behavioral: N-backBehavioral: SpanBehavioral: Multisensory

Interventions

N-backBEHAVIORAL

The training program is a personal device-based adaptive version of a visual N-back task, either devoid of game elements or embedded in a gamified platform game

Condition 1Condition 2
SpanBEHAVIORAL

The training program is a personal device-based adaptive version of a visual working memory span task, either devoid of game elements or embedded in a gamified platform game

Condition 1Condition 2
MultisensoryBEHAVIORAL

The training program is a personal device-based adaptive version of an N-back task that features visual stimuli (Unisensory) or visual stimuli paired with unique sounds (Multisensory) and is devoid of game elements

Condition 1Condition 2

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Able to understand and speak English and follow study procedures
  • Does not have a psychological or neurological condition that would prevent being able to give consent to participate
  • Not currently involved in any other cognitive or memory training studies

You may not qualify if:

  • Formal diagnosis of dementia or other neurological disease, including Mild cognitive impairment.
  • A final total score below 17 on Montreal Cognitive Assessment - Blind (telephone) version.
  • Score of 10 or more on the Generalized Anxiety Questionnaire (GAD7; Spitzer et al., 2006, Archives of Internal Medicine), indicating presence of moderate or severe anxiety
  • Score of 9 or more on Geriatric depression scale (GDS15; Yesavage et al., 1982) indicating presence of moderate or severe depression
  • Abnormal visual acuity prohibitive of tablet-based training.
  • Physical handicap (motor or perceptual) that would impede training procedures.
  • Medical illness requiring treatment and/or significant absences during the study timeline.
  • Current evidence or 2-yr history of seizures, focal brain lesion, or head injury with loss of consciousness.
  • Current alcohol consumption exceeds 14 drinks per week.
  • Self-reported illicit drug use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, Irvine

Irvine, California, 92697, United States

Location

University of California, Riverside

Riverside, California, 92521, United States

Location

Related Publications (5)

  • Pahor A, Mester RE, Carrillo AA, Ghil E, Reimer JF, Jaeggi SM, Seitz AR. UCancellation: A new mobile measure of selective attention and concentration. Behav Res Methods. 2022 Oct;54(5):2602-2617. doi: 10.3758/s13428-021-01765-5. Epub 2022 Feb 1.

    PMID: 35106729BACKGROUND
  • Pahor A, Stavropoulos T, Jaeggi SM, Seitz AR. Validation of a matrix reasoning task for mobile devices. Behav Res Methods. 2019 Oct;51(5):2256-2267. doi: 10.3758/s13428-018-1152-2.

    PMID: 30367386BACKGROUND
  • Royle J, Lincoln NB. The Everyday Memory Questionnaire-revised: development of a 13-item scale. Disabil Rehabil. 2008;30(2):114-21. doi: 10.1080/09638280701223876.

    PMID: 17852284BACKGROUND
  • Pahor A, Collins C, Smith RN, Moon A, Stavropoulos T, Silva I, Peng E, Jaeggi SM, Seitz AR. Multisensory Facilitation of Working Memory Training. J Cogn Enhanc. 2021 Sep;5(3):386-395. doi: 10.1007/s41465-020-00196-y. Epub 2020 Nov 27.

    PMID: 34485810BACKGROUND
  • Sandeep S, Shelton CR, Pahor A, Jaeggi SM, Seitz AR. Application of Machine Learning Models for Tracking Participant Skills in Cognitive Training. Front Psychol. 2020 Jul 22;11:1532. doi: 10.3389/fpsyg.2020.01532. eCollection 2020.

    PMID: 32793032BACKGROUND

Study Officials

  • Aaron R Seitz, Phd

    University of California, Riverside

    PRINCIPAL INVESTIGATOR
  • Susanne M Jaeggi, Phd

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Three randomized crossover trials (N-back, Span and Multisensory) will be conducted and in each trial, participants will be randomly assigned to 1 of 2 conditions: Condition 1 consists of training type 1 followed by training type 2, whereas Condition 2 consists of training type 2 followed by training type 1. In the N-back trial, participants will be assigned to Non-Gamified N-back training and Gamified N-back training. In the Span trial, they will be assigned to Non-Gamified Span training and Gamified Span training and in the Multisensory trial, they will be assigned to Non-gamified Unisensory N-back training and Non-gamified Multisensory N-back training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Project Scientist

Study Record Dates

First Submitted

April 21, 2022

First Posted

May 31, 2022

Study Start

March 17, 2022

Primary Completion

March 5, 2025

Study Completion

March 5, 2025

Last Updated

March 12, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

All individual participant data (anonymized).

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available persistently at the conclusion of the study.
Access Criteria
There are no access criteria.

Locations