NCT05506852

Brief Summary

Executive control processes involve initiate, coordinate, synchronize, and regulate elemental cognitive functions for the conduct of goal-directed behavior. The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control processes will improve cognitive performance in cognitively healthy older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 25, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 17, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 19, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

July 25, 2022

Results QC Date

February 23, 2026

Last Update Submit

March 18, 2026

Conditions

Keywords

cognitioncognitive trainingnon-pharmacological interventionvideo gamecognitive enhancementcomputer-basedteleneuropsychologycomputerizedattention controlexecutive controlcognitive declinemulti-tasking

Outcome Measures

Primary Outcomes (4)

  • Changes in the Breakfast Game Performance: Number of Tables Set Score

    Change in the total number of tables set. In the computerized task, participants are asked to set tables for four guests. When finished, one point is given. Higher scores represent a better outcome. This metric represents a change in the score = the higher means improvement in the performance. The total score ranges between 0 and 12; the total change score ranged from -3 to +3.

    Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12

  • Changes in the Breakfast Game Performance: Cooking Time Range of Stop Times Scores

    Change in cooking time (milliseconds) between food items. In the computerized task, participants are asked to cook different food types. Scores reflect the difference between the first and last food item that was stopped cooking. Lower scores (closest to zero) represent a better outcome. This metric represents a change in the score = the lower means improvement on the performance. The total score ranges between 0.3 and 315; the total change score ranges from -40 to +40.

    Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12

  • Change in Breakfast Game Performance: Cooking Time Discrepancy Scores

    Change in cooking time (milliseconds) in each food type. In the computerized task, participants are asked to cook different food types. Scores reflect the average absolute values of the difference between the required and actual cooking time of each item. Lower scores (closest to zero) represent a better outcome. This metric represents a change in the score = the lower means improvement in the performance. The total score ranges between 0.3 and 175; The total change score ranges from -20 to +20.

    Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12

  • Transfer to Complex Executive/Attention Control Measure (Proximal Outcome).

    Accuracy on the Alphanumeric Task. This metric represents a change in the score. The higher the means more improvement in the performance. The total change score ranged from -0.1 to +0.1

    Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)

Secondary Outcomes (5)

  • Transfer to Executive Functions Composite Z-Score (Distal Outcome)

    Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)

  • Transfer to the General Self-efficacy Scale (Distal Outcome)

    Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)

  • Transfer to Beck Depression Inventory (Distal Outcome)

    Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)

  • Transfer to Beck Anxiety Inventory (Distal Outcome)

    Within the 2 weeks before intervention starts, and the 6th week, after the last (13th) training session. (Measure represent the change between pre and post training)

  • Transfer to Cognition-Leisure Questionnaire (Distal Outcome)

    Within the 2 weeks before intervention starts, and the 6th week, after the last (12th) training session. (Measure represent the change between pre and post training)

Study Arms (2)

Strategy Training

EXPERIMENTAL

Participants will play the Breakfast Game with training strategy.

Behavioral: Web-based training strategy

Regular Approach

ACTIVE COMPARATOR

Participants will play the Breakfast Game without training strategy.

Behavioral: Web-based regular training (no strategy)

Interventions

Participants will undergo a web-based training protocol where they will play an online game that simulates a breakfast environment and will perform everyday activities as "cooking" and "setting tables" in a multi-tasking fashion. Participants will learn to play the game using specific strategies, in order to optimize the performance.

Also known as: Experimental intervention
Strategy Training

Participants will undergo a web-based training protocol where they will play an online game that simulates a breakfast environment and will perform everyday activities as "cooking" and "setting tables" in a multi-tasking fashion. Participants will learn to play the game under regular game instructions.

Also known as: Control intervention
Regular Approach

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. Sharon Sanz Simon
Organization
Columbia University (previous); Rutgers University (current)

Study Officials

  • Sharon Sanz Simon, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be aware of the difference across the two conditions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2022

First Posted

August 18, 2022

Study Start

January 17, 2023

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

March 19, 2026

Results First Posted

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available within 6 months of study completion.
Access Criteria
Data access requests will be reviewed by the principal investigator.

Locations