What this study is
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 immediately after completing the training, and the tests of memory and thinking three months after completing the training
What's being tested
- Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT-MCI)
Intervention · BEHAVIORAL
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)
Intervention · BEHAVIORAL
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.
Study details
- Official title
- Telehealth-Adapted Compensatory Training and Intervention for Cognition for People With Mild Cognitive Impairment
- Sponsor
- University of Florida
- Conditions
- MCI · Mild Cognitive Impairment · Mild Cognitive Impairment (MCI)
- Enrolling
- 100 people
- Starts
- 2026-05-29
- Est. completion
- 2027-08
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 65 Years – 84 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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 or 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUniversity of Florida
Gainesville, Florida, United States
Recruiting
Study team
Sponsor
University of Florida
Study ID IRB202501616
Principal investigator
Cameron K Perrin, M.S.
University of Florida
Principal investigator
Joseph M Gullett, Ph.D.
University of Florida
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.