Recruiting

RBSEF-CCT-MCI & ME-CCT

Sponsor:

Rosalind Franklin University of Medicine and Science

Code:

NCT06330844

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

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

Study ID

NCT06330844

Start date

Mar 1, 2025

Status verified date

Apr, 2025

Completion date

Mar 15, 2028

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

9 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: RBSEF-CCT-MCI

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

other: Control Group: ME-CCT

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

Interventions

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:

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.

Primary outcome measure

  • Verbal learning and memory [ Time Frame: up to eight weeks ]
  • Basic auditory attention and working memory [ Time Frame: up to eight weeks ]
  • Psychomotor processing speed [ Time Frame: up to eight weeks ]
  • Psychomotor processing speed; executive functioning [ Time Frame: up to eight weeks ]
  • Self-report of prospective and retrospective memory [ Time Frame: up to eight weeks ]
  • Self-report of cognitive concerns [ Time Frame: up to eight weeks ]
  • The Patient Health Questionnaire-9 [ Time Frame: up to eight weeks ]
  • Self-report symptoms of anxiety [ Time Frame: up to eight weeks ]
  • Self-reported daily functioning [ Time Frame: up to eight weeks ]
  • The Racial Microaggressions Scale [ Time Frame: up to eight weeks ]
  • The Trauma Symptoms of Discrimination Scale [ Time Frame: up to eight weeks ]

Central Contacts and Locations

Central contacts

Rachael L Ellison, PhD

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

Locations

Rosalind Franklin University of Medicine and Science

Recruiting

Chicago, Illinois, United States, 60064

Contacts

Rachael Ellison, PhD

312-940-1718

Principal Investigator:

Rachael Ellison, PhD

More Information

Sponsor

Rosalind Franklin University of Medicine and Science

Last update posted

Jul 24, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rosalind Franklin University of Medicine and Science on 2025-07-24.