Race-Based Stress and Cognitive Training for MCI

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rosalind Franklin University of Medicine and Science
Study ID
NCT06330844
Status
Recruiting
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Conditions

  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Mar 26, 2024
Start date
Mar 1, 2025
Status verified
Apr 2025
Primary completion
Sep 15, 2027
Completion
Mar 15, 2028

Study Design

Enrollment
9 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Verbal learning and memory [ Time Frame: up to eight weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rosalind Franklin University of Medicine and ScienceChicagoIllinois60064
Rachael Ellison, PhD
312-940-1718
Rachael Ellison, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Rosalind Franklin University of Medicine and Science· Chicago, IL

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