Improving Executive Control in Cognitively Healthy Older Adults: the MUltitasking STrategy (MUST) Study

Official title

Web-based Technology and Cognitive Training: Improving Executive Control in Cognitively Healthy Older Adults: the MUltitasking STrategy (MUST) Study

Overview

Developing efficient cognitive intervention for cognitively health older adults is a major public health goal, due to its potential for reducing age-related cognitive decline and Alzheimer's disease/dementia risk. Executive Control is a relevant cognitive target since it declines with aging and is critical for multi-tasking in daily life. The proposed research investigates whether playing a web-based cognitive complex game (the Breakfast Game) impacts cognitive performance in cognitively healthy older adults. To be enrolled in the study, participants will be asked to undergo a cognitive sassessment, health questionnires, and a blood exam. The intervention consist in one educational session on healthy aging, and 10 one-hour cognitive training sessions 2-3 times a week over one month. Participants will be asked to repeat the cognitive assessment within 1-2 weeks after the intervention, and after three months.

Detailed description

The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control / multi-tasking abilities will improve cognitive performance in cognitively healthy older adults. Cognitively normal adults aged 60-75 will be randomized into three groups: 1) Web-based game with training strategy (Experimental); 2) Web-based game without training strategy (Active Control); 3) No intervention group (Passive control). Participants in groups 1 and 2 will be instructed to play the complex, high-demand online game, the Breakfast Game, for 10 one-hour sessions over 4 weeks. At study entry all participants will be asked to complete a cognitive assessment, health questionnaires, a blood exam and and education session on healthy aging. After the intervention, participants will be asked to repeat the cogntive assessment within 1-2 weeks, and after 3 months.

Interventions

• Behavioral Web-based Cognitive Training (with strategy)
  Participants will learn to play a complex online game using specific guidance or strategy.
• Behavioral Web-based Cognitive Training (without strategy)
  Participants will learn to play a complex online game without specific guidance or strategy.

Primary outcome measures

• Changes in the Breakfast Game scores [Time frame: Training session 1, week 1; training 10, approximately 4 weeks.]
• Transfer to complex executive/attention control measure (Proximal outcome). [Time frame: At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)]

Secondary outcome measures (4)

• Transfer to executive functions composite measure (Proximal outcome) [Time frame: At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)]
• Transfer to Everyday Cognition Scale (ECOG) (Distal outcome) [Time frame: At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)]
• Transfer to Mindful Attention Awareness Scale (MAAS) (Distal outcome) [Time frame: At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)]
• Transfer to Self Efficacy for Cognitive Everyday Tasks (Distal outcome) [Time frame: At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)]

Eligibility criteria

Inclusion criteria

• Age 60-75
• Adequate English proficiency
• Willingness to adhere to training protocol:

• Attend 2 in-person assessments
• Attend a blood test
• Attend online intervention sessions and online follow-up assessment

Exclusion criteria

• Low test scores (below 26 on the Montreal Cognitive Assessment)
• Known history of cognitive impairment, dementia, stroke, seizure disorder, or other neuropsychiatric condition judged to impact cognitive performance.
• Taking medications known to influence cognitive performance.
• Sensory (e.g. visual, auditory) or physical (e.g. severe arthritic, orthopedic, neurologic) impairment incompatible with use of a standard computer workstation.
• Enrolled in a concurrent study that could affect the outcome of this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Rutgers New Jersey Medical School, Behavior Health Sciences Building, F-Level — Newark

Publications

• Blumen HM, Gopher D, Steinerman JR, Stern Y. Training cognitive control in older adults with the space fortress game: the role of training instructions and basic motor ability. Front Aging Neurosci. 2010 Nov 11;2:145. doi: 10.3389/fnagi.2010.00145. eCollection 2010. PMID 21120135
• Stern Y, Blumen HM, Rich LW, Richards A, Herzberg G, Gopher D. Space Fortress game training and executive control in older adults: a pilot intervention. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2011 Nov;18(6):653-77. doi: 10.1080/13825585.2011.613450. Epub 2011 Oct 12. PMID 21988726
• Sanz Simon S, Ben-Eliezer D, Pondikos M, Stern Y, Gopher D. Feasibility and acceptability of a new web-based cognitive training platform for cognitively healthy older adults: the breakfast task. Pilot Feasibility Stud. 2023 Aug 4;9(1):136. doi: 10.1186/s40814-023-01359-2. PMID 37542331

Identifiers

NCT: NCT06995638 · Pro2025000330 · 4R00AG078561-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗