Race-Based Stress and Cognitive Training for MCI

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06330844
• Other study ID #: RBSEF-MCI-CCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: March 15, 2027

Study information

• Verified date: March 2024
• Source: Rosalind Franklin University of Medicine and Science
• Contact: Rachael L Ellison, PhD
• Phone: (847) 578-3000
• Email: rachael.ellison[@]rosalindfranklin.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: March 15, 2027
• Est. primary completion date: September 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.
• Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT)
ME-CCT focuses on: Cognitive training, psychotherapeutic, and lifestyle techniques. Incorporates CCT techniques designed to help patients manage problems with memory, attention, and executive functions (i.e., organization, planning, decision-making, and problem-solving). Includes mindfulness-based stress reduction practice which has been shown to improve cognitive and neuropsychiatric function in various populations.

Locations

Country	Name	City	State
United States	Rosalind Franklin University of Medicine and Science	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rosalind Franklin University of Medicine and Science

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal learning and memory	Assessed by the California Verbal Learning Test- Second Edition (CVLT-II)	up to eight weeks
Primary	Basic auditory attention and working memory	Assessed by the Digit Span subtest of the Wechsler Adult Intelligence Scale (WAIS-IV)	up to eight weeks
Primary	Psychomotor processing speed	Assessed by the Coding and Symbol search subtests of the WAIS-IV	up to eight weeks
Primary	Psychomotor processing speed; executive functioning	As assessed by the Stroop Test	up to eight weeks
Primary	Self-report of prospective and retrospective memory	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.	up to eight weeks
Primary	Self-report of cognitive concerns	Neuro-QOL (neuro-quality of life); applied cognition: general concerns & executive functioning (EF) subscales	up to eight weeks
Primary	The Patient Health Questionnaire-9	(i.e., PHQ-9; assessing self-report symptoms of depression)	up to eight weeks
Primary	Self-report symptoms of anxiety	As assessed by the Generalized Anxiety Disorder-7 questionnaire (i.e., GAD-7)	up to eight weeks
Primary	Self-reported daily functioning	As assessed by The World Health Organization Disability Assessment Schedule 2.0 (i.e., WHODAS 2.0)	up to eight weeks
Primary	The Racial Microaggressions Scale	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.	up to eight weeks
Primary	The Trauma Symptoms of Discrimination Scale	Self-report measure assessing the traumatizing impact of discrimination broadly by measuring anxiety-related symptoms of trauma due to discriminatory experiences	up to eight weeks