Recruiting

Cognitive Training

Sponsor:

University of Florida

Code:

NCT07366346

Conditions

MCI

Mild Cognitive Impairment

Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT-MCI)

Brief Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (bME-CCT-MCI)

Study Details

Brief summary:

The goal of this clinical trial is to develop a five-week virtual cognitive training intervention for people with Mild Cognitive Impairment (MCI) based off an existing eight-week intervention. The main question it aims to answer is:

• Is five weeks of training as good as eight weeks in improving cognition, quality of life, daily functioning, and mood, and in reducing caregiver burden? Researchers will compare five weeks of cognitive training to eight weeks of training to see if the shorter version is as effective as the full training.

Participants will complete all activities virtually:

  • Complete a screening visit with a study partner (typically a family member, roommate, or close friend) to determine eligibility to participate in the study
  • Complete some tests of memory and thinking and some questionnaires
  • Attend weekly two-hour group cognitive training sessions with a trained group leader, for five or eight weeks
  • Redo the questionnaires and tests of memory and thinking immediately after completing the training, and three months after completing the training

Conditions

MCI

Mild Cognitive Impairment

Mild Cognitive Impairment (MCI)

Study ID

NCT07366346

Start date

May 29, 2026

Status verified date

Jan, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 65 years of age or older, less than 85 years
  • Have the ability to speak and understand English
  • Time and willingness to commit to the completion of this study
  • Availability of a study partner (typically a relative, spouse, offspring, or roommate) for initial and post-intervention testing
  • A global Clinical Dementia Rating scale (CDR) score of 0.5 and cognitive performance of <26 on the Montreal Cognitive Assessment (MoCA) or <19 on the MoCA-BLIND for categorization of MCI, as determined in the screening appointment.

Exclusion Criteria:

  • Self-reported diagnosis of dementia or functional impairment that requires assistance
  • Recent changes in medications for memory (i.e., prescribed or changed medications for memory within 30 days)
  • Major psychiatric illness (schizophrenia, current substance dependence, or undertreated depression or anxiety), or 15-item Geriatric Depression Scale (GDS-15) score of eight or higher
  • Hearing, vision, or motor deficits that would interfere with standardized cognitive assessment or participation in study interventions: e.g., inability to hear through headphones (with or without hearing aids). If vision is corrected with lenses to appropriate levels, then participant will be eligible
  • No access to reliable, stable internet, OR
  • Current participation in another cognitive training program or treatment study.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brief cognitive training (5 weeks)

Participants in this group will attend the brief, five-week version of cognitive training

active comparator: Full cognitive training (8 weeks)

Participants in this group will attend the full, eight-week version of cognitive training

Interventions

Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT-MCI)

ME-CCT-MCI is a publicly available manual for people with mild cognitive impairment (MCI) which has shown effectiveness in improving cognitive performance. Course material will be from the manualized protocol by Huckans and Twamley et al. (2018). The manual includes brief motivational interviewing techniques and modules designed to support behaviors that enhance cognition, such as physical activity, strategies to support learning and memory, mindfulness, and the use of day planners and calendars. It includes the use of frequent breaks, and at-home practice exercises. Each weekly session will be completed in groups of 8-10 participants, and will be led by trained intervention leaders.

Brief Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (bME-CCT-MCI)

bME-CCT-MCI is a shortened version of the full ME-CCT-MCI, from eight weeks to five weeks. It preserves core principles of cognitive compensation and habit learning, with a booster summary session in week 5 to reinforce retention. Other than the condensed material, sessions are the same as those in the full ME-CCT-MCI.

Primary outcome measure

  • Change in cognition [ Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline) ]
  • Change in quality of life [ Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline) ]
  • Change in subjective cognition [ Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline) ]
  • Change in reported daily functioning [ Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline) ]
  • Change in objective functional status [ Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline) ]
  • Change in anxiety [ Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline) ]
  • Change in depression [ Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline) ]
  • Change in caregiver burden [ Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline) ]

Central Contacts and Locations

Central contacts

Cameron K Perrin, M.S.

352-294-8765c.perrin@phhp.ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

More Information

Sponsor

University of Florida

Last update posted

Jun 3, 2026

Last verified

Jan, 2026

Keywords

  • cognitive training
  • compensatory cognitive training
  • mild cognitive impairment
  • cognitive decline
  • cognitive intervention
  • cognitive strategies
  • group intervention
  • everyday functioning
  • cognition
  • brain health
  • dementia prevention
  • dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-03.