Telehealth-Adapted Compensatory Training and Intervention for Cognition

Официальное название

Telehealth-Adapted Compensatory Training and Intervention for Cognition for People With Mild Cognitive Impairment

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Change in cognition [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]

Вторичные конечные точки (1)

• Individual characteristics that predict cognitive benefits of intervention [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Florida — Gainesville

Публикации

• 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. PMID 23471631
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07366346 · IRB202501616

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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