NCT06330844 · Rosalind Franklin University of Medicine and Science
Race-Based Stress and Cognitive Training for MCI
What this study is about
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 randomly assigned controlled trial (RCT) (Phase 2) to compare the effectiveness of the RBSEF-CCT-MCI with the ME-CCT. In the RCT, 75-150 participants will be randomly assigned 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Verbal learning and memory
Time frame: up to eight weeks
Assessed by the California Verbal Learning Test- Second Edition (CVLT-II)
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)
Psychomotor processing speed
Time frame: up to eight weeks
Assessed by the Coding and Symbol search subtests of the WAIS-IV
Psychomotor processing speed; executive functioning
Time frame: up to eight weeks
As assessed by the Stroop Test
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.
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
The Patient Health Questionnaire-9
Time frame: up to eight weeks
(i.e., PHQ-9; assessing self-report symptoms of depression)
Self-report symptoms of anxiety
Time frame: up to eight weeks
As assessed by the Generalized Anxiety Disorder-7 questionnaire (i.e., GAD-7)
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)
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.
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2025 · Source of record for eligibility and locations