RECRUITING

Race-Based Stress and Cognitive Training for MCI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment

Quick Facts

Study Start:2025-03-01

Study Completion:2028-03-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06330844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Rachael L Ellison, PhD

CONTACT

(847) 578-3000

rachael.ellison@rosalindfranklin.edu

Principal Investigator

Rachael L Ellison, PhD

PRINCIPAL_INVESTIGATOR

Rosalind Franklin University of Medicine and Science

Study Locations (Sites)

Rosalind Franklin University of Medicine and Science

Chicago, Illinois, 60064

United States

Collaborators and Investigators

Sponsor: Rosalind Franklin University of Medicine and Science

Rachael L Ellison, PhD, PRINCIPAL_INVESTIGATOR, Rosalind Franklin University of Medicine and Science

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01

Study Completion Date2028-03-15

Study Record Updates

Study Start Date2025-03-01

Study Completion Date2028-03-15

Terms related to this study

Additional Relevant MeSH Terms

Mild Cognitive Impairment