Telehealth-Adapted Compensatory Training and Intervention for Cognition

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07366346
Status
Recruiting
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Conditions

  • MCI
  • Mild Cognitive Impairment
  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
65 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

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

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

Key Dates

Start date
May 29, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32608-

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By research site
University of Florida· Gainesville, FL

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