Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Verbal learning and memory
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Verbal learning and memory
时间窗: up to eight weeks
Assessed by the California Verbal Learning Test- Second Edition (CVLT-II)
Basic auditory attention and working memory
时间窗: up to eight weeks
Assessed by the Digit Span subtest of the Wechsler Adult Intelligence Scale (WAIS-IV)
Psychomotor processing speed
时间窗: up to eight weeks
Assessed by the Coding and Symbol search subtests of the WAIS-IV
Self-report of cognitive concerns
时间窗: up to eight weeks
Neuro-QOL (neuro-quality of life); applied cognition: general concerns \& executive functioning (EF) subscales
The Patient Health Questionnaire-9
时间窗: up to eight weeks
(i.e., PHQ-9; assessing self-report symptoms of depression)
Psychomotor processing speed; executive functioning
时间窗: up to eight weeks
As assessed by the Stroop Test
Self-reported daily functioning
时间窗: up to eight weeks
As assessed by The World Health Organization Disability Assessment Schedule 2.0 (i.e., WHODAS 2.0)
Self-report of prospective and retrospective memory
时间窗: up to eight weeks
The Prospective and Retrospective Memory Questionnaire (PRMQ). The PRMQ developed to provide a self-report measure of prospective and retrospective memory slips in everyday life. It consists of sixteen items, eight asking about prospective memory failures, and eight concerning retrospective failures.
Self-report symptoms of anxiety
时间窗: up to eight weeks
As assessed by the Generalized Anxiety Disorder-7 questionnaire (i.e., GAD-7)
The Racial Microaggressions Scale
时间窗: up to eight weeks
Assessing the occurrence and distress elicited by racial indignities, slights, mistreatment, or offenses that people of color may face on a recurrent or consistent basis.
The Trauma Symptoms of Discrimination Scale
时间窗: up to eight weeks
Self-report measure assessing the traumatizing impact of discrimination broadly by measuring anxiety-related symptoms of trauma due to discriminatory experiences
次要结局
未报告次要终点
研究者
Rachael Ellison
Principle Investigator
Rosalind Franklin University of Medicine and Science