Telehealth-Adapted Compensatory Training and Intervention for Cognition

NCT07366346 | Not Yet Recruiting

• 1 other identifier: IRB202501616
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

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

Outcome Measures

Primary Outcomes (8)

• 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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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

  Baseline

Other Outcomes (2)

• Treatment satisfaction

  End of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)

• Familiarity with Telehealth

  Baseline

Study Arms (2)

Brief cognitive training (5 weeks)

EXPERIMENTAL

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

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

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

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.

Full cognitive training (8 weeks)

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.

Brief cognitive training (5 weeks)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older
• 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.

You may not qualify if:

• Self-reported diagnosis of dementia, stroke, traumatic brain injury, brain tumor, or a neurological disorder that affects cognition or would interfere with the ability to benefit from the study intervention (e.g., Parkinson disease, multiple sclerosis, essential tremors), or any other unstable medical condition that is predisposing to imminent cognitive or functional decline (e.g., congestive heart failure, chronic obstructive pulmonary disorder dependent on oxygen, or undergoing chemotherapy or radiation)
• Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality) or any history of agitation and/or delirium
• Hearing or vision deficits that would interfere with standardized cognitive assessment or participation in study interventions: i.e. inability to hear through headphones (with or without hearing aids), macular degeneration or other significant diseases that cause severe loss of vision. If vision is corrected with lenses to appropriate levels, then participant will be eligible.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

Related Publications (24)

• 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.

  BACKGROUND

• 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.

  PMID: 23471631 BACKGROUND

• Lindamer 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.

  PMID: 36528588 BACKGROUND

• Juul 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.

  PMID: 37328755 BACKGROUND

• Stypulkowski 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.

  PMID: 37195804 BACKGROUND

• Beekly 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.

  PMID: 17804958 BACKGROUND

• Huang 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.

  PMID: 32955146 BACKGROUND

• Nasreddine 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.

  PMID: 15817019 BACKGROUND

• Spitzer 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.

  PMID: 16717171 BACKGROUND

• Lai 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.

  PMID: 24700645 BACKGROUND

• Zarit 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.

  PMID: 7203086 BACKGROUND

• Gullett 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.

  PMID: 34950021 BACKGROUND

• Twamley 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.

  PMID: 24805894 BACKGROUND

• Paggetti 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.

  PMID: 39485657 BACKGROUND

• Luxton 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.

  PMID: 40166965 BACKGROUND

• Gopi Y, Wilding E, Madan CR. Memory rehabilitation: restorative, specific knowledge acquisition, compensatory, and holistic approaches. Cogn Process. 2022 Nov;23(4):537-557. doi: 10.1007/s10339-022-01099-w. Epub 2022 Jul 5.

  PMID: 35790619 BACKGROUND

• Jak A. Cognitive Rehabilitation for Adults with a History of Traumatic Brain Injury. Neurol Clin. 2024 Nov;42(4):931-941. doi: 10.1016/j.ncl.2024.05.015. Epub 2024 Jun 15.

  PMID: 39343485 BACKGROUND

• Fox NC, Belder C, Ballard C, Kales HC, Mummery C, Caramelli P, Ciccarelli O, Frederiksen KS, Gomez-Isla T, Ismail Z, Paquet C, Petersen RC, Perneczky R, Robinson L, Sayin O, Frisoni GB. Treatment for Alzheimer's disease. Lancet. 2025 Sep 27;406(10510):1408-1423. doi: 10.1016/S0140-6736(25)01329-7. Epub 2025 Sep 22.

  PMID: 40997839 BACKGROUND

• Majdi A, van Boekholdt L, Sadigh-Eteghad S, Mc Laughlin M. A systematic review and meta-analysis of transcranial direct-current stimulation effects on cognitive function in patients with Alzheimer's disease. Mol Psychiatry. 2022 Apr;27(4):2000-2009. doi: 10.1038/s41380-022-01444-7. Epub 2022 Feb 3.

  PMID: 35115703 BACKGROUND

• Heidebrink JL, Paulson HL. Lessons Learned from Approval of Aducanumab for Alzheimer's Disease. Annu Rev Med. 2024 Jan 29;75:99-111. doi: 10.1146/annurev-med-051022-043645.

  PMID: 38285515 BACKGROUND

• Olivares D, Deshpande VK, Shi Y, Lahiri DK, Greig NH, Rogers JT, Huang X. N-methyl D-aspartate (NMDA) receptor antagonists and memantine treatment for Alzheimer's disease, vascular dementia and Parkinson's disease. Curr Alzheimer Res. 2012 Jul;9(6):746-58. doi: 10.2174/156720512801322564.

  PMID: 21875407 BACKGROUND

• Danysz W, Parsons CG. The NMDA receptor antagonist memantine as a symptomatological and neuroprotective treatment for Alzheimer's disease: preclinical evidence. Int J Geriatr Psychiatry. 2003 Sep;18(Suppl 1):S23-32. doi: 10.1002/gps.938.

  PMID: 12973747 BACKGROUND

• Anand P, Singh B. A review on cholinesterase inhibitors for Alzheimer's disease. Arch Pharm Res. 2013 Apr;36(4):375-99. doi: 10.1007/s12272-013-0036-3. Epub 2013 Feb 24.

  PMID: 23435942 BACKGROUND

• Birks J. Cholinesterase inhibitors for Alzheimer's disease. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD005593. doi: 10.1002/14651858.CD005593.

  PMID: 16437532 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Cameron K Perrin, M.S.

  University of Florida

  PRINCIPAL INVESTIGATOR

• Joseph M Gullett, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cameron K Perrin, M.S.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 26, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made fully accessible after the study is completed and published, and before the PI (Cameron Perrin) has graduated in 2028. Open Science Framework is designed to support long-term preservation of research data, so the data will be accessible for as long as this service is available.
• Access Criteria: Access to this scientific data will not be controlled and will be made publicly available on Open Science Framework.

Locations

US (1)