MCITACTICNCT07366346
Telehealth-Adapted Compensatory Training and Intervention for Cognition
A study testing Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT-MCI) and Brief Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (bME-CCT-MCI) in people with MCI and Mild Cognitive Impairment, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 84 years
- Conditions the study is for
- MCI, Mild Cognitive Impairment, Mild Cognitive Impairment (MCI)
- What is being tested?
- Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT-MCI) and Brief Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (bME-CCT-MCI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 84 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
About this study
Official title: Telehealth-Adapted Compensatory Training and Intervention for Cognition for People With Mild Cognitive Impairment
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.
Read more
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
Read the detailed description
The purpose of this project is to assess the efficacy of brief and full compensatory cognitive training protocols in people diagnosed with Mild Cognitive Impairment (MCI), a state often thought of as a transitory stage between normal aging and dementia. According to the Alzheimer's Association, one in three older adults dies with Alzheimer's disease or another dementia. In 2024, Alzheimer's disease and other dementias were estimated to cost approximately $360 billion, and these costs are only expected to grow, with estimates rising over $1 trillion by 2050. Research on dementia interventions is growing, with research on neurotransmitter augmentation showing cognitive improvement, and more recently, brain stimulation showing gains in memory and general cognition. However, brain stimulation is not yet approved by the U.S. Food and Drug Administration, and eligibility for anti-amyloid medications is restricted to patients with Alzheimer's Disease pathology and low risk profiles, severely limiting accessibility for many patients. Cognitive rehabilitation is a low-cost solution that is not restricted to patients meeting certain requirements or with a specific etiology and can be utilized by any trained clinician.
Cognitive training and rehabilitation is typically categorized as either restorative or compensatory. Restorative training involves repetitive tasks targeting specific cognitive domains (e.g., attention, memory) by harnessing the brain's plasticity and is often completed via computer-based exercises, but often lacks generalizability. Compensatory rehabilitation focuses on individualized strategies that use alternative cognitive processes and supportive aids to compensate for impairment rather than improving it. Cognitive training generally improves quality of life more than pharmacological treatments, and cognitive rehabilitation is particularly effective at improving functional ability and reducing caregiver burden.
Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) is a compensatory cognitive training program which uses cognitive strategies to improve cognition and daily functioning. Originally developed for veterans with traumatic brain injury, it includes a publicly available manual for people with MCI called Motivationally Enhanced Compensatory Cognitive Training for MCI (ME-CCT-MCI), which has shown effectiveness in improving functional ability. This program consists of eight two-hour sessions delivered once per week over eight weeks. However, approximately 74% of providers report modifying CogSMART by combining, modifying, or omitting exercises. Despite this, no research to date has examined the effectiveness of an abbreviated version, though evidence from shorter-term psychotherapy suggests it is not significantly less effective than longer-term approaches. This study will develop and implement a five-session version of ME-CCT-MCI, to reduce time burdens and increase accessibility, feasibility, and adherence for patients, caregivers, and providers.
This proposal advances current science in several ways. First, it further validates the ME-CCT-MCI manual. Though extensive research supported the development of this manual, there has been only one randomized controlled trial validating its use, and only a small number of studies that have since validated its use outside of a Veterans Affairs setting. Of these studies, only two include an assessment of effects on cognition, one of which cites the Indian Adapted ME-CCT-MCI, and the other uses a similar manual adapted for addictions, with no study validating the original manual's effect on cognition. Second, creating and testing a brief version of this manual allows for improved accessibility and feasibility, reducing the risk of dropout. Third, the use of an extensive neuropsychological battery (the National Alzheimer's Coordinating Center Uniform Data Set [NACC-UDS]) allows assessment of improvement in specific cognitive domains. Though the randomized controlled trial did assess effects on objective cognition, it found only a nonsignificant trend and assessed general cognition rather than specific domains. Other research has shown that compensatory cognitive rehabilitation is beneficial to cognition, but there is less clear evidence of the specific pattern of effect on cognitive domains, which may help inform clinical decision making in determining which patients may benefit the most from this intervention. Fourth, this study will investigate what participant factors (i.e., education, baseline cognition, lifestyle, and hippocampal volume) predict benefit of intervention, further determining which patients may benefit from this intervention and contributing to future development of personalized medicine.
- Being tested
- 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)
- 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
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT-MCI)Behavioural
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)Behavioural
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 group | Role | What they receive |
|---|---|---|
| Brief cognitive training (5 weeks) | Experimental | Participants in this group will attend the brief, five-week version of cognitive training Receives: Behavioral: Brief Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (bME-CCT-MCI) |
| Full cognitive training (8 weeks) | Active comparator | Participants in this group will attend the full, eight-week version of cognitive training Receives: Behavioral: Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT-MCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognition
As assessed by the National Alzheimer's Coordinating Center Uniform Data Set version 4 (NACC-UDSv4). This full neuropsychological assessment consists of neuropsychological tests including: Montreal Cognitive Assessment (MoCA)-BLIND, Craft Story 21, Benson Complex Figure, Number Span Test (Forward and Backward), Category Fluency, Trail Making Test, Verbal Fluency: Phonemic Test, Rey Auditory Verbal Learning Test (RAVLT), and Multilingual Naming Test (MINT). On most of these tasks a higher score indicates better cognition, except for on Trail Making Test, where a lower score indicates faster time (better cognition).
Measured: 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
As assessed by the Quality of Life in Alzheimer's Disease (QOL-AD), completed by participant and study partner, where higher scores indicate better quality of life (range 13-52).
Measured: 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
As assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 Cognitive Function 8a, a self-report cognitive functioning questionnaire, where a higher score indicates better reported cognition (range 8-40).
Measured: 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
As assessed by the National Alzheimer's Coordinating Center (NACC) Functional Assessment Scale (FAS), completed by the study partner, where a lower score indicates more independence (range 0 to 30).
Measured: 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
As assessed by the internet-based Bill-Paying Task, an objective measure of functional status which can be administered online, as a test of participants' ability to pay fictional bills. A higher score indicates more severe deficits (range 0-25).
Measured: 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
As assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale, a self-report questionnaire of anxiety, where higher scores indicate higher levels of anxiety (range 0 to 21).
Measured: 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
As assessed by the Geriatric Depression Scale (GDS), a self-report questionnaire of depression, where higher scores indicate higher levels of depression (range 0 to 15).
Measured: 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
As assessed by the Zarit Burden Interview (ZBI), completed by study partner, where a higher score indicates higher burden (range 0 to 48).
Measured: 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)
Secondary outcomes (1)
Individual characteristics that predict cognitive benefits of intervention
Assess moderation effects of education, baseline cognitive scores, baseline physical activity levels and sleep, and neuroimaging (Magnetic Resonance Imaging [MRI]) on predicting a greater benefit of intervention on cognition.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start29 May 2026
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for MCIStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cameron K Perrin, M.S., Principal investigator, University of FloridaJoseph M Gullett, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366346
- Sponsor's protocol ID
- IRB202501616
- Acronym
- TACTIC
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The cognitive assessment data will be deidentified and made publicly available upon study completion. Permission to disseminate the neuroimaging data to a larger audience has not been granted so this will not be included in the publicly available dataset. A data dictionary will be available accompanying the cognitive assessment data. The manual for the compensatory training intervention (Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment) is already publicly available, and any changes made in this study to create a brief version will also be shared. Code created to analyze the results data (in R, python, or MATLAB) will be cleaned for comprehension and shared to support replication.
Publications
Campbell, L., Maye, J., Thomas, K., Pickell, D., Keller, A., Mahmood, Z., Sano, E., Austin, T., Zakrzewski, J., Silverman, I., Thomas, M., Jak, A., O'Neill, M., & Twamley, E. (2026, February 6). Motivationally Enhanced Compensatory Cognitive Training for Older Veterans with Mild Cognitive Impairment: A Randomized Controlled Trial. INS Philadelphia 2026: The 54th Annual Meeting.
Huckans M, Hutson L, Twamley E, Jak A, Kaye J, Storzbach D. Efficacy of cognitive rehabilitation therapies for mild cognitive impairment (MCI) in older adults: working toward a theoretical model and evidence-based interventions. Neuropsychol Rev. 2013 Mar;23(1):63-80. doi: 10.1007/s11065-013-9230-9. Epub 2013 Mar 8.
PubMed 23471631Lindamer L, Almklov E, Pittman JOE, Shi S, Maye J, Jak A, Twamley E, Rabin B. Multi-method study of the implementation of Cognitive Symptom Management and Rehabilitation Training (CogSMART) in real-world settings. BMC Health Serv Res. 2022 Dec 17;22(1):1542. doi: 10.1186/s12913-022-08941-z.
PubMed 36528588Juul S, Jakobsen JC, Jorgensen CK, Poulsen S, Sorensen P, Simonsen S. The difference between shorter- versus longer-term psychotherapy for adult mental health disorders: a systematic review with meta-analysis. BMC Psychiatry. 2023 Jun 16;23(1):438. doi: 10.1186/s12888-023-04895-6.
PubMed 37328755Stypulkowski K, Anquillare E, Twamley EW, Thayer RE. Feasibility of a Telehealth Compensatory Cognitive Training Program for Older Adults with Mild Cognitive Impairment. Clin Gerontol. 2024 Jan-Dec;47(1):17-25. doi: 10.1080/07317115.2023.2213694. Epub 2023 May 17.
PubMed 37195804Beekly DL, Ramos EM, Lee WW, Deitrich WD, Jacka ME, Wu J, Hubbard JL, Koepsell TD, Morris JC, Kukull WA; NIA Alzheimer's Disease Centers. The National Alzheimer's Coordinating Center (NACC) database: the Uniform Data Set. Alzheimer Dis Assoc Disord. 2007 Jul-Sep;21(3):249-58. doi: 10.1097/WAD.0b013e318142774e.
PubMed 17804958Huang HC, Tseng YM, Chen YC, Chen PY, Chiu HY. Diagnostic accuracy of the Clinical Dementia Rating Scale for detecting mild cognitive impairment and dementia: A bivariate meta-analysis. Int J Geriatr Psychiatry. 2021 Feb;36(2):239-251. doi: 10.1002/gps.5436. Epub 2020 Oct 9.
PubMed 32955146Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Lai JS, Wagner LI, Jacobsen PB, Cella D. Self-reported cognitive concerns and abilities: two sides of one coin? Psychooncology. 2014 Oct;23(10):1133-41. doi: 10.1002/pon.3522. Epub 2014 Apr 3.
PubMed 24700645Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
PubMed 7203086Gullett JM, Albizu A, Fang R, Loewenstein DA, Duara R, Rosselli M, Armstrong MJ, Rundek T, Hausman HK, Dekosky ST, Woods AJ, Cohen RA. Baseline Neuroimaging Predicts Decline to Dementia From Amnestic Mild Cognitive Impairment. Front Aging Neurosci. 2021 Dec 7;13:758298. doi: 10.3389/fnagi.2021.758298. eCollection 2021.
PubMed 34950021Twamley EW, Jak AJ, Delis DC, Bondi MW, Lohr JB. Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for veterans with traumatic brain injury: pilot randomized controlled trial. J Rehabil Res Dev. 2014;51(1):59-70. doi: 10.1682/JRRD.2013.01.0020.
PubMed 24805894Paggetti A, Druda Y, Sciancalepore F, Della Gatta F, Ancidoni A, Locuratolo N, Piscopo P, Vignatelli L, Sagliocca L, Guaita A, Secreto P, Stracciari A, Caffarra P, Vanacore N, Fabrizi E, Lacorte E; Italian Dementia Guideline Working Group. The efficacy of cognitive stimulation, cognitive training, and cognitive rehabilitation for people living with dementia: a systematic review and meta-analysis. Geroscience. 2025 Feb;47(1):409-444. doi: 10.1007/s11357-024-01400-z. Epub 2024 Nov 1.
PubMed 39485657Luxton D, Thorpe N, Crane E, Warne M, Cornwall O, El-Dalil D, Matthews J, Rajkumar AP. Systematic review of the efficacy of pharmacological and non-pharmacological interventions for improving quality of life of people with dementia. Br J Psychiatry. 2026 Jan;228(1):55-67. doi: 10.1192/bjp.2025.11. Epub 2025 Apr 1.
PubMed 40166965
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth-Adapted Compensatory Training and Intervention for Cognition for People With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07366346
- Acronym / sponsor ID
- TACTIC / IRB202501616
- Keywords
- cognitive training, compensatory cognitive training, mild cognitive impairment, cognitive decline, cognitive intervention, cognitive strategies, group intervention, everyday functioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 29 May 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The purpose of this project is to assess the efficacy of brief and full compensatory cognitive training protocols in people diagnosed with Mild Cognitive Impairment (MCI), a state often thought of as a transitory stage between normal aging and dementia. According to the Alzheimer's Association, one in three older adults dies with Alzheimer's disease or another dementia. In 2024, Alzheimer's disease and other dementias were estimated to cost approximately $360 billion, and these costs are only expected to grow, with estimates rising over $1 trillion by 2050. Research on dementia interventions is growing, with research on neurotransmitter augmentation showing cognitive improvement, and more recently, brain stimulation showing gains in memory and general cognition. However, brain stimulation is not yet approved by the U.S. Food and Drug Administration, and eligibility for anti-amyloid medications is restricted to patients with Alzheimer's Disease pathology and low risk profiles, severely limiting accessibility for many patients. Cognitive rehabilitation is a low-cost solution that is not restricted to patients meeting certain requirements or with a specific etiology and can be utilized by any trained clinician.
Cognitive training and rehabilitation is typically categorized as either restorative or compensatory. Restorative training involves repetitive tasks targeting specific cognitive domains (e.g., attention, memory) by harnessing the brain's plasticity and is often completed via computer-based exercises, but often lacks generalizability. Compensatory rehabilitation focuses on individualized strategies that use alternative cognitive processes and supportive aids to compensate for impairment rather than improving it. Cognitive training generally improves quality of life more than pharmacological treatments, and cognitive rehabilitation is particularly effective at improving functional ability and reducing caregiver burden.
Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) is a compensatory cognitive training program which uses cognitive strategies to improve cognition and daily functioning. Originally developed for veterans with traumatic brain injury, it includes a publicly available manual for people with MCI called Motivationally Enhanced Compensatory Cognitive Training for MCI (ME-CCT-MCI), which has shown effectiveness in improving functional ability. This program consists of eight two-hour sessions delivered once per week over eight weeks. However, approximately 74% of providers report modifying CogSMART by combining, modifying, or omitting exercises. Despite this, no research to date has examined the effectiveness of an abbreviated version, though evidence from shorter-term psychotherapy suggests it is not significantly less effective than longer-term approaches. This study will develop and implement a five-session version of ME-CCT-MCI, to reduce time burdens and increase accessibility, feasibility, and adherence for patients, caregivers, and providers.
This proposal advances current science in several ways. First, it further validates the ME-CCT-MCI manual. Though extensive research supported the development of this manual, there has been only one randomized controlled trial validating its use, and only a small number of studies that have since validated its use outside of a Veterans Affairs setting. Of these studies, only two include an assessment of effects on cognition, one of which cites the Indian Adapted ME-CCT-MCI, and the other uses a similar manual adapted for addictions, with no study validating the original manual's effect on cognition. Second, creating and testing a brief version of this manual allows for improved accessibility and feasibility, reducing the risk of dropout. Third, the use of an extensive neuropsychological battery (the National Alzheimer's Coordinating Center Uniform Data Set [NACC-UDS]) allows assessment of improvement in specific cognitive domains. Though the randomized controlled trial did assess effects on objective cognition, it found only a nonsignificant trend and assessed general cognition rather than specific domains. Other research has shown that compensatory cognitive rehabilitation is beneficial to cognition, but there is less clear evidence of the specific pattern of effect on cognitive domains, which may help inform clinical decision making in determining which patients may benefit the most from this intervention. Fourth, this study will investigate what participant factors (i.e., education, baseline cognition, lifestyle, and hippocampal volume) predict benefit of intervention, further determining which patients may benefit from this intervention and contributing to future development of personalized medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief cognitive training (5 weeks) | Experimental | Behavioral: Brief Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (bME-CCT-MCI)Participants in this group will attend the brief, five-week version of cognitive training |
| Full cognitive training (8 weeks) | Active comparator | Behavioral: Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT-MCI)Participants in this group will attend the full, eight-week version of cognitive training |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Full cognitive training (8 weeks) |
| 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. | Behavioural | Brief cognitive training (5 weeks) |
Primary outcome
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)
As assessed by the National Alzheimer's Coordinating Center Uniform Data Set version 4 (NACC-UDSv4). This full neuropsychological assessment consists of neuropsychological tests including: Montreal Cognitive Assessment (MoCA)-BLIND, Craft Story 21, Benson Complex Figure, Number Span Test (Forward and Backward), Category Fluency, Trail Making Test, Verbal Fluency: Phonemic Test, Rey Auditory Verbal Learning Test (RAVLT), and Multilingual Naming Test (MINT). On most of these tasks a higher score indicates better cognition, except for on Trail Making Test, where a lower score indicates faster time (better cognition).
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)
As assessed by the Quality of Life in Alzheimer's Disease (QOL-AD), completed by participant and study partner, where higher scores indicate better quality of life (range 13-52).
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)
As assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 Cognitive Function 8a, a self-report cognitive functioning questionnaire, where a higher score indicates better reported cognition (range 8-40).
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)
As assessed by the National Alzheimer's Coordinating Center (NACC) Functional Assessment Scale (FAS), completed by the study partner, where a lower score indicates more independence (range 0 to 30).
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)
As assessed by the internet-based Bill-Paying Task, an objective measure of functional status which can be administered online, as a test of participants' ability to pay fictional bills. A higher score indicates more severe deficits (range 0-25).
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)
As assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale, a self-report questionnaire of anxiety, where higher scores indicate higher levels of anxiety (range 0 to 21).
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)
As assessed by the Geriatric Depression Scale (GDS), a self-report questionnaire of depression, where higher scores indicate higher levels of depression (range 0 to 15).
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)
As assessed by the Zarit Burden Interview (ZBI), completed by study partner, where a higher score indicates higher burden (range 0 to 48).
1 secondary outcome
Individual characteristics that predict cognitive benefits of intervention
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- BackgroundCampbell, L., Maye, J., Thomas, K., Pickell, D., Keller, A., Mahmood, Z., Sano, E., Austin, T., Zakrzewski, J., Silverman, I., Thomas, M., Jak, A., O'Neill, M., & Twamley, E. (2026, February 6). Motivationally Enhanced Compensatory Cognitive Training for Older Veterans with Mild Cognitive Impairment: A Randomized Controlled Trial. INS Philadelphia 2026: The 54th Annual Meeting.
- Background: PubMed 23471631Huckans M, Hutson L, Twamley E, Jak A, Kaye J, Storzbach D. Efficacy of cognitive rehabilitation therapies for mild cognitive impairment (MCI) in older adults: working toward a theoretical model and evidence-based interventions. Neuropsychol Rev. 2013 Mar;23(1):63-80. doi: 10.1007/s11065-013-9230-9. Epub 2013 Mar 8.
- Background: PubMed 36528588Lindamer L, Almklov E, Pittman JOE, Shi S, Maye J, Jak A, Twamley E, Rabin B. Multi-method study of the implementation of Cognitive Symptom Management and Rehabilitation Training (CogSMART) in real-world settings. BMC Health Serv Res. 2022 Dec 17;22(1):1542. doi: 10.1186/s12913-022-08941-z.
- Background: PubMed 37328755Juul S, Jakobsen JC, Jorgensen CK, Poulsen S, Sorensen P, Simonsen S. The difference between shorter- versus longer-term psychotherapy for adult mental health disorders: a systematic review with meta-analysis. BMC Psychiatry. 2023 Jun 16;23(1):438. doi: 10.1186/s12888-023-04895-6.
- Background: PubMed 37195804Stypulkowski K, Anquillare E, Twamley EW, Thayer RE. Feasibility of a Telehealth Compensatory Cognitive Training Program for Older Adults with Mild Cognitive Impairment. Clin Gerontol. 2024 Jan-Dec;47(1):17-25. doi: 10.1080/07317115.2023.2213694. Epub 2023 May 17.
- Background: PubMed 17804958Beekly DL, Ramos EM, Lee WW, Deitrich WD, Jacka ME, Wu J, Hubbard JL, Koepsell TD, Morris JC, Kukull WA; NIA Alzheimer's Disease Centers. The National Alzheimer's Coordinating Center (NACC) database: the Uniform Data Set. Alzheimer Dis Assoc Disord. 2007 Jul-Sep;21(3):249-58. doi: 10.1097/WAD.0b013e318142774e.
- Background: PubMed 32955146Huang HC, Tseng YM, Chen YC, Chen PY, Chiu HY. Diagnostic accuracy of the Clinical Dementia Rating Scale for detecting mild cognitive impairment and dementia: A bivariate meta-analysis. Int J Geriatr Psychiatry. 2021 Feb;36(2):239-251. doi: 10.1002/gps.5436. Epub 2020 Oct 9.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 24700645Lai JS, Wagner LI, Jacobsen PB, Cella D. Self-reported cognitive concerns and abilities: two sides of one coin? Psychooncology. 2014 Oct;23(10):1133-41. doi: 10.1002/pon.3522. Epub 2014 Apr 3.
- Background: PubMed 7203086Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
- Background: PubMed 34950021Gullett JM, Albizu A, Fang R, Loewenstein DA, Duara R, Rosselli M, Armstrong MJ, Rundek T, Hausman HK, Dekosky ST, Woods AJ, Cohen RA. Baseline Neuroimaging Predicts Decline to Dementia From Amnestic Mild Cognitive Impairment. Front Aging Neurosci. 2021 Dec 7;13:758298. doi: 10.3389/fnagi.2021.758298. eCollection 2021.
- Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT-MCI) manualLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The cognitive assessment data will be deidentified and made publicly available upon study completion. Permission to disseminate the neuroimaging data to a larger audience has not been granted so this will not be included in the publicly available dataset. A data dictionary will be available accompanying the cognitive assessment data. The manual for the compensatory training intervention (Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment) is already publicly available, and any changes made in this study to create a brief version will also be shared. Code created to analyze the results data (in R, python, or MATLAB) will be cleaned for comprehension and shared to support replication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cameron K Perrin, M.S. principal investigator
University of Florida
Joseph M Gullett, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT-MCI) and Brief Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (bME-CCT-MCI) in people with MCI and Mild Cognitive Impairment, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cameron K Perrin, M.S. (352-294-8765, c.perrin@phhp.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07366346, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.