Race-Based Stress and Cognitive Training for MCI

NCT06330844 | Recruiting

• 1 other identifier: RBSEF-MCI-CCT
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (11)

• Verbal learning and memory

  Assessed by the California Verbal Learning Test- Second Edition (CVLT-II)

  up to eight weeks

• Basic auditory attention and working memory

  Assessed by the Digit Span subtest of the Wechsler Adult Intelligence Scale (WAIS-IV)

  up to eight weeks

• Psychomotor processing speed

  Assessed by the Coding and Symbol search subtests of the WAIS-IV

  up to eight weeks

• Psychomotor processing speed; executive functioning

  As assessed by the Stroop Test

  up to eight weeks

• 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

• Self-report of cognitive concerns

  Neuro-QOL (neuro-quality of life); applied cognition: general concerns \& executive functioning (EF) subscales

  up to eight weeks

• The Patient Health Questionnaire-9

  (i.e., PHQ-9; assessing self-report symptoms of depression)

  up to eight weeks

• Self-report symptoms of anxiety

  As assessed by the Generalized Anxiety Disorder-7 questionnaire (i.e., GAD-7)

  up to eight weeks

• 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

• 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

• 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

Study Arms (2)

Experimental: RBSEF-CCT-MCI

EXPERIMENTAL

Participants will complete the newly developed RBSE-CCT-MCI training program.

Behavioral: Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI)

Control Group: ME-CCT

OTHER

Participants will complete the original, ME-CCT training program.

Behavioral: Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT)

Interventions

Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI) BEHAVIORAL

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.

Experimental: RBSEF-CCT-MCI

Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT) BEHAVIORAL

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.

Control Group: ME-CCT

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rosalind Franklin University of Medicine and Science: lead

Study Sites (1)

Rosalind Franklin University of Medicine and Science

Chicago, Illinois, 60064, United States

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• Nayak US. Design participation by the thousand elders. Stud Health Technol Inform. 1998;48:423-7. No abstract available.

  PMID: 10186562 BACKGROUND

• 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.

  PMID: 3504986 BACKGROUND

• 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.

  PMID: 4700211 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 5756074 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Rachael L Ellison, PhD

  Rosalind Franklin University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachael L Ellison, PhD

CONTACT

(847) 578-3000; rachael.ellison@rosalindfranklin.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Two groups assignment - One group will complete the original ME-CCT training program. The other group will complete the newly developed RBSE-CCT-MCI.

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: March 26, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): March 15, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)