GAMES Intervention in MCI (Mild Cognitive Impairment)

NCT07296133 | Recruiting DMC

• 2 other identifiers: 2025P0116531R44AG078009-01
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present study is to evaluate whether online, remote gameplay can facilitate social engagement and reduce feelings of loneliness and isolation in adults with and without mild cognitive impairment (MCI).

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (4)

• Change in friendship Scale score

  The scale consists of 5 core items, each with a 5-point frequency response (Almost always to Not at all). Total possible score range is 5-25. Higher scores indicate greater feelings of social isolation (worse study outcome).

  Pre-intervention (Baseline), week 6 and post-intervention (week 12)

• Change in UCLA Loneliness Scale score

  This is a self -report scale with 20 items. Participants rate each item on a 4-point Likert scale: (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often). Total possible score ranges from 20 to 80, with higher scores indicating greater perceived loneliness (worse study outcome).

  Pre-intervention (Baseline), week 6 and post-intervention (week 12)

• Change in Neuro-QOL score

  Neuro-QOL ("Quality of Life in Neurological Disorders") consists of a scale designed to measure health-related quality of life across a variety of neurological conditions. The abbreviated form comprises short forms (8-10 items each) covering 13 key domains: physical, mental, and social health. Response format for each item ranges from "Never" to "Always" or severity levels like "None" to "Cannot do". Scores are summarized and represented with T-scores (mean = 50, SD = 10), derived from their respective calibrated item questionnaire. Higher scores correlate with worse outcome.

  Pre-intervention (Baseline), week 6 and post-intervention (week 12)

• Change in meaning and purpose score

  This scale measures an individual's sense of meaning, purpose, and life satisfaction. Includes 8-9 items in the short form, with statements like "My life has meaning" or "I have a sense of purpose," rated on a 5-point (from 1=never to 5=always). Scores are expressed as T-scores (mean = 50, SD = 10). Higher scores represent better outcome (more positive well-being).

  Pre-intervention (Baseline), week 6 and post-intervention (week 12)

Secondary Outcomes (2)

• Change in Tech Experience and Comfort scale score

  Pre-intervention (Baseline), week 6 and post-intervention (week 12)

• Change in Perceived Stress score

  Pre-intervention (Baseline), week 6 and post-intervention (week 12)

Study Arms (2)

Online Gameplay Intervention Group

EXPERIMENTAL

Participants will receive: * brief (\< 10 minutes) psychoeducation about the importance of engaging in social activities to support cognitive stimulation and brain health * technology session to show them how to access games via OneClick * participants will receive weekly calls from study staff to provide support and briefly query about social activities that week. * A subset of questionnaires will be re-administered after 6 weeks of the intervention to capture any change occurring at intervention mid-point. * Following completion of the 12-week intervention, participants will repeat a subset of baseline questionnaires to evaluate for change over time.

Behavioral: Online Gameplay Intervention

Wait-list control Group

OTHER

Participants will receive: * brief (\< 10 minutes) psychoeducation about the importance of engaging in social activities to support cognitive stimulation and brain health * Participants will be notified that study team will receive weekly phone calls to ask about social activities they completed in the week prior. * Following completion of the 12-week waitlist period, participants will repeat the baseline questionnaires to evaluate for change over time. * After completing the waitlist condition, they will be offered the opportunity to complete the gameplay intervention.

Behavioral: Waitlist control

Interventions

Online Gameplay Intervention BEHAVIORAL

-The online gameplay intervention includes playing online versions of common games (such as Connect 4 and Uno) with a partner, 3 times per week for at least 15 minutes, for 12 weeks. All games will be delivered via a novel online platform (OneClick; developed by PotLuck, LLC) created specifically to support and enhance social engagement with family members and close friends. * Participants will receive weekly calls from study staff to provide support and briefly query about social activities that week. * They will not receive reminders or be contacted by the study outside of the weekly phone calls, apart from mid intervention questionnaires.

Online Gameplay Intervention Group

Waitlist control BEHAVIORAL

\- Participants will be informed that study team will contact them once per week by telephone for 12 weeks, to ask about social activities they completed in the week prior.

Wait-list control Group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 85 years old
• Living independently (note: can live in assisted living, but must have independently complete daily activities)
• Fluent in English
• Adequate visual and auditory acuity to see/hear computer screen
• MoCA-Blind (converted to MoCA score) \> 17
• Additional Criteria for MCI Group:
• Existing diagnosis by HC professional
• MoCA-Blind (converted to MoCA score) of 18-25
• FAQ \< 9

You may not qualify if:

• Cognitive impairment secondary to stroke, TBI or other neurological cause without concern for neurodegenerative condition (e.g., Alzheimer's disease, vascular dementia, etc.)
• Medical illnesses that would prevent participation
• Major psychiatric disturbance meeting DSM V criteria in last year
• Hx of substance abuse within last two years
• Current psychoactive med use

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kayci Vickers, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayci Vickers, PhD

CONTACT

(404) 712-4849; kayci.lynne.vickers@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: December 22, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available within 3 months of acceptance for publication and will end 5 years after initial publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal, to achieve aims in approved proposal. Proposals should be directed to kvicker@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data will be made available for 5 years.

Locations

US (1)