NCT06330844 Race-Based Stress and Cognitive Training for MCI
| NCT ID | NCT06330844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rosalind Franklin University of Medicine and Science |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2027-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 9 participants in total. It began in 2025-03-01 with a primary completion date of 2027-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Rachael L Ellison, PhD
PRINCIPAL INVESTIGATOR
Rosalind Franklin University of Medicine and Science
Frequently Asked Questions
Who can join the NCT06330844 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06330844 currently recruiting?
Yes, NCT06330844 is actively recruiting participants. Contact the research team at rachael.ellison@rosalindfranklin.edu for enrollment information.
Where is the NCT06330844 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06330844 clinical trial?
NCT06330844 is sponsored by Rosalind Franklin University of Medicine and Science. The principal investigator is Rachael L Ellison, PhD at Rosalind Franklin University of Medicine and Science. The trial plans to enroll 9 participants.