NCT06330844

Race-Based Stress and Cognitive Training for MCI

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Rosalind Franklin University of Medicine and Science · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-09-15
• Completion: 2028-03-15
• First posted: 2024-03-26
• Last updated: 2025-07-24

Locations

1 site across 1 country: United States