Clinical trial NCT05396586: Understanding Individual Differences in Working Memory Training and Transfer in Older Adults
Official title: Assessment and Training of Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Lead sponsor: Northeastern University
Sponsor class: OTHER
Collaborators: name: University of California, Riverside
name: National Institute on Aging (NIA)
First posted: 2022-05-31
Enrollment: 313
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Three randomized cross-over trials will be conducted to obtain within-subject comparisons of training with enriched (game-like) versions of working memory training tasks compared to basic (non-gamified) versions of these tasks. 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.

Each trial involves a total of 50 sessions per participant: the first few sessions consist of completing questionnaires and computerized cognitive assessments (pre-test). Participants then complete 20 sessions of working memory training. After a mid-test, they complete 20 sessions of a different type of working memory training. Post-test is administered upon training completion, and at least a month later, participants complete 3 follow-up sessions. The study can be administered either in person or remotely; however, the investigators anticipate that most participants will complete the study remotely.

Eligibility criteria: Inclusion Criteria:

* 50-85 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in N-level
timeFrame: Day 24, Day 46, Day 78
measure: Change in Corsi span
timeFrame: Day 25, Day 47, Day 79
measure: Change in Inhibitory Control Composite Score
timeFrame: Day 24, Day 46, Day 78
measure: Change in Everyday Memory Questionnaire Revised
timeFrame: Day 24, Day 46, Day 77
Secondary outcomes:
measure: Training Experience Enjoyment Subscale I
timeFrame: Day 24
measure: Training Experience Enjoyment Subscale II
timeFrame: Day 46
measure: Training Experience Difficulty Subscale I
timeFrame: Day 24
measure: Training Experience Difficulty Subscale II
timeFrame: Day 46
measure: Training Experience Subjective Progress Subscale I
timeFrame: Day 24
measure: Training Experience Subjective Progress Subscale II
timeFrame: Day 46
measure: Training Experience Interface Subscale I
timeFrame: Day 24
measure: Training Experience Interface Subscale II
timeFrame: Day 46
measure: Exit Survey
timeFrame: Day 79
Other outcomes:
measure: Change in General Cognitive Ability Composite Score
timeFrame: Day 77
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Riverside
country: United States
facility: University of California, Riverside
state: California
Study officials:
affiliation: University of California, Riverside
name: Aaron R Seitz, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Susanne M Jaeggi, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.