Race-Based Stress and Cognitive Training for MCI
Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rachael L Ellison, PhD
- Phone Number: (847) 578-3000
- Email: rachael.ellison@rosalindfranklin.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60064
- Recruiting
- Rosalind Franklin University of Medicine and Science
-
Principal Investigator:
- Rachael Ellison, PhD
-
Contact:
- Rachael Ellison, PhD
- Phone Number: 312-940-1718
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: RBSEF-CCT-MCI
Participants will complete the newly developed RBSE-CCT-MCI training program.
|
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.
|
|
Other: Control Group: ME-CCT
Participants will complete the original, ME-CCT training program.
|
ME-CCT focuses on:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Verbal learning and memory
Time Frame: up to eight weeks
|
Assessed by the California Verbal Learning Test- Second Edition (CVLT-II)
|
up to eight weeks
|
|
Basic auditory attention and working memory
Time Frame: up to eight weeks
|
Assessed by the Digit Span subtest of the Wechsler Adult Intelligence Scale (WAIS-IV)
|
up to eight weeks
|
|
Psychomotor processing speed
Time Frame: up to eight weeks
|
Assessed by the Coding and Symbol search subtests of the WAIS-IV
|
up to eight weeks
|
|
Psychomotor processing speed; executive functioning
Time Frame: up to eight weeks
|
As assessed by the Stroop Test
|
up to eight weeks
|
|
Self-report of prospective and retrospective memory
Time Frame: 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.
|
up to eight weeks
|
|
Self-report of cognitive concerns
Time Frame: up to eight weeks
|
Neuro-QOL (neuro-quality of life); applied cognition: general concerns & executive functioning (EF) subscales
|
up to eight weeks
|
|
The Patient Health Questionnaire-9
Time Frame: up to eight weeks
|
(i.e., PHQ-9; assessing self-report symptoms of depression)
|
up to eight weeks
|
|
Self-report symptoms of anxiety
Time Frame: up to eight weeks
|
As assessed by the Generalized Anxiety Disorder-7 questionnaire (i.e., GAD-7)
|
up to eight weeks
|
|
Self-reported daily functioning
Time Frame: up to eight weeks
|
As assessed by The World Health Organization Disability Assessment Schedule 2.0 (i.e., WHODAS 2.0)
|
up to eight weeks
|
|
The Racial Microaggressions Scale
Time Frame: 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.
|
up to eight weeks
|
|
The Trauma Symptoms of Discrimination Scale
Time Frame: 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
|
up to eight weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rachael L Ellison, PhD, Rosalind Franklin University of Medicine and Science
Publications and helpful links
General Publications
- 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.
- 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.
- Nayak US. Design participation by the thousand elders. Stud Health Technol Inform. 1998;48:423-7. No abstract available.
- Kremer A, Focaccia G, Ferreyra R, Kraly A, Sniechowski T. [The epidemiology of cancer in the Province of Neuquen, Argentina]. Medicina (B Aires). 1987;47(5):471-6. No abstract available. Spanish.
- Fritsch J, Wolf P. [Cog-rail extension corset in the surgical management of scoliosis]. Beitr Orthop Traumatol. 1973 Feb;20(2):124-7. No abstract available. German.
- Inoue S. Uptake of 3-H-DL-leucine and 3-H-uridine by the caudal neurosecretory system of the loach (Misgurnus anguillicaudatus) maintained in vitro. Endocrinol Jpn. 1968 Dec;15(4):505-7. doi: 10.1507/endocrj1954.15.505. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBSEF-MCI-CCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.