Telehealth-Adapted Compensatory Training and Intervention for Cognition

N/ANot Yet RecruitingNCT07366346

University of Florida100 enrolled

Overview

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

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.

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 65 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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).

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)

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).

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).

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).

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).

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).

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).

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).

Secondary Outcomes

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.

Time frame: Baseline