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

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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