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Race-Based Stress and Cognitive Training for MCI - Trial NCT06330844

Access comprehensive clinical trial information for NCT06330844 through Pure Global AI's free database. This phase not specified trial is sponsored by Rosalind Franklin University of Medicine and Science and is currently Not yet recruiting. The study focuses on Mild Cognitive Impairment. Target enrollment is 9 participants.

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NCT06330844
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behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06330844
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Race-Based Stress and Cognitive Training for MCI
Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment

Study Focus

Mild Cognitive Impairment

Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI)

Interventional

behavioral

Sponsor & Location

Rosalind Franklin University of Medicine and Science

Chicago, United States of America

Timeline & Enrollment

N/A

Jun 15, 2024

Mar 15, 2027

9 participants

Primary Outcome

Verbal learning and memory,Basic auditory attention and working memory,Psychomotor processing speed,Psychomotor processing speed; executive functioning,Self-report of prospective and retrospective memory,Self-report of cognitive concerns,The Patient Health Questionnaire-9,Self-report symptoms of anxiety,Self-reported daily functioning,The Racial Microaggressions Scale,The Trauma Symptoms of Discrimination Scale

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.

ICD-10 Classifications

Mild cognitive disorder
Alzheimer disease
Dementia in other specified diseases classified elsewhere
Dementia in other diseases classified elsewhere
Dementia in Alzheimer disease

Data Source

ClinicalTrials.gov

NCT06330844

Non-Device Trial