Race-Based Stress and Cognitive Training for MCI

Официальное название

Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment

Обзор

This a two phase project that aims to pilot a new adaptation (Phase 1) of Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT; an originally VA-based cognitive rehabilitation manualized intervention for older adults with MCI, with a focus on the impact of stress on cognitive functioning; that integrates components from the Race Based Stress and Empowerment (RBSE) group for an increased focus on race-based stress and discrimination for racial minority older adults (i.e., RBSEF-CCT-MCI). In a pilot open trial, 75-150 participants will receive group-based intervention for 8 weeks, with 8-10 participants per group. Following the pilot study, the investigators will complete a randomized controlled trial (RCT) (Phase 2) to compare the efficacy of the RBSEF-CCT-MCI with the ME-CCT. In the RCT, 75-150 participants will be randomized into either 1) The active control group, who will complete the original, ME-CCT training program, or 2) The experimental group, who will complete the newly developed RBSE-CCT-MCI. Both research groups will complete the interventions for 8 weeks, with 8-10 participants per group. Hypothesis: Participation in this newly developed/updated intervention (i.e., RBSEF-CCT-MCI) will result in improvements in both (a) subjective and (b) objective cognitive functioning, and (c) self-reported mental health symptoms.

Подробное описание

African American (AA) individuals are at higher risk for non-normative cognitive decline, particularly due to increased rates of cardiovascular and cerebrovascular risk factors. These types of risk factors (e.g., hypertension, diabetes mellitus, obesity, hyperlipidemia, etc.) are independently associated with brain imaging changes, even before potential clinical manifestation of cardiovascular or cerebrovascular disease.

When compared to the general aging population, AA adults experience disproportionately higher rates of hypertension as well as both an earlier age of onset and higher concomitant morbidity and mortality from hypertension when compared to any other racial/ethnic group in the US. AA individuals experience greater exposure to specific chronic stressors, such as discrimination and low socioeconomic status, as well as report higher overall levels of stress compared to white individuals. However, racial disparities in hypertension rates persist even after controlling for socioeconomic status. Researchers have failed to demonstrate any risk factors that are biologically unique to AA patients. These findings have led researchers to consider other psychosocial and environmental factors that may explain the observed hypertension disparities, namely, racial discrimination and racial segregation.

AA older adults are not only at higher risk for non-normative cognitive decline due to both semi-direct (i.e., increased risk of cardiovascular/cerebrovascular risk factors, such as HTN), but other factors such as race-related stress may not only exacerbate these risk factors, but also interfere day-to-day with optimal cognitive performance due to overall increased stress and diversion of cognitive resources. Therefore, for AA older adults, there is an increased need not only for interventions that help to compensate for cognitive decline and increase daily functioning, but also an increased need for an intervention to reduce the effects of race-related stressors. The proposed Race-Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI) as proposed in this pilot, is one such intervention that would accomplish those aims and has the potential for a significant impact on patient care for AA older adults who could benefit from additional tools and strategies to improve cognitive functioning and increase day-to-day independent functioning.

Of note, original authors of both protocols have granted consent for modifications of their interventions, and the investigators already have a draft of the new protocol.

Вмешательства

• Поведенческое Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI)
  RBSEF-CCT-MCI differs from ME-CCT in that this intervention integrates psychoeducation and strategies for processing and coping with race/ethnicity-related stressors, as part of the larger conversation in ME-CCT regarding stress, and how stress interferes with attention, learning, and subsequently one's subjective sense of memory.
• Поведенческое Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT)
  ME-CCT focuses on: 1. Cognitive training, psychotherapeutic, and lifestyle techniques. 2. Incorporates CCT techniques designed to help patients manage problems with memory, attention, and executive functions (i.e., organization, planning, decision-making, and problem-solving). 3. Includes mindfulness-based stress reduction practice which has been shown to improve cognitive and neuropsychiatric function in various populations.

Первичные конечные точки

• Verbal learning and memory [Срок оценки: up to eight weeks]
• Basic auditory attention and working memory [Срок оценки: up to eight weeks]
• Psychomotor processing speed [Срок оценки: up to eight weeks]
• Psychomotor processing speed; executive functioning [Срок оценки: up to eight weeks]
• Self-report of prospective and retrospective memory [Срок оценки: up to eight weeks]
• Self-report of cognitive concerns [Срок оценки: up to eight weeks]
• The Patient Health Questionnaire-9 [Срок оценки: up to eight weeks]
• Self-report symptoms of anxiety [Срок оценки: up to eight weeks]
• Self-reported daily functioning [Срок оценки: up to eight weeks]
• The Racial Microaggressions Scale [Срок оценки: up to eight weeks]

Критерии участия

Критерии включения

• The study will be conducted in-person, so they must be able to travel to Rosalind Franklin University.
• The study will initially be limited to participants who self-identify as Black/African American, or who self-identify with other racial/ethnic groups in addition to self-identifying as Black/African-American; however, may be expanded to include participants that identify as Hispanic/Latine.

Критерии исключения

• Participants are ineligible to participate in this study if they are not at least 65 years of age and are not experiencing at least mild cognitive impairment or self-reported cognitive difficulties.
• Participants will also be excluded if they have a diagnosis of dementia (i.e., major neurocognitive disorder), intellectual disability, mild head injury (i.e., concussion) within the last six months, and/or a history of moderate to severe traumatic brain injury.
• Diagnosis of dementia may be from self-report or other medical records, or for participants to fail screening cognitive assessments (i.e., the RBANS) that would suggest they may be at the level of dementia (i.e., major neurocognitive disorder) as ultimately determined by study PI with objective scores less then 2 standard deviations below the mean on the RBANS.

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

• Rosalind Franklin University of Medicine and Science — Chicago

Публикации

• 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
• Cenat JM. Complex Racial Trauma: Evidence, Theory, Assessment, and Treatment. Perspect Psychol Sci. 2023 May;18(3):675-687. doi: 10.1177/17456916221120428. Epub 2022 Oct 26. PMID 36288462
• Mahdy Ali K, Wonnerth A, Huber K, Wojta J. Cardiovascular disease risk reduction by raising HDL cholesterol--current therapies and future opportunities. Br J Pharmacol. 2012 Nov;167(6):1177-94. doi: 10.1111/j.1476-5381.2012.02081.x. PMID 22725625
• Anazodo UC, Shoemaker JK, Suskin N, Ssali T, Wang DJ, St Lawrence KS. Impaired Cerebrovascular Function in Coronary Artery Disease Patients and Recovery Following Cardiac Rehabilitation. Front Aging Neurosci. 2016 Jan 5;7:224. doi: 10.3389/fnagi.2015.00224. eCollection 2015. PMID 26779011
• Spruill TM, Butler MJ, Thomas SJ, Tajeu GS, Kalinowski J, Castaneda SF, Langford AT, Abdalla M, Blackshear C, Allison M, Ogedegbe G, Sims M, Shimbo D. Association Between High Perceived Stress Over Time and Incident Hypertension in Black Adults: Findings From the Jackson Heart Study. J Am Heart Assoc. 2019 Nov 5;8(21):e012139. doi: 10.1161/JAHA.119.012139. Epub 2019 Oct 16. PMID 31615321
• Dolezsar CM, McGrath JJ, Herzig AJM, Miller SB. Perceived racial discrimination and hypertension: a comprehensive systematic review. Health Psychol. 2014 Jan;33(1):20-34. doi: 10.1037/a0033718. PMID 24417692

Идентификаторы

NCT: NCT06330844 · RBSEF-MCI-CCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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